- Email: [email protected]
Comparison of the Performance of Mask Ventilation Between Face Masks With and Without Air Cushion
Journal Pre-proof The comparison of the performance of mask ventilation between face masks with and without air cushion. Masanori Tsukamoto, DDS, Ph.D., Assistant Professor, Shiori Taura, DDS, Graduate student, Takashi Hitosugi, DDS, Ph.D., Assistant Professor, Takeshi Yokoyama, DDS, Ph.D., Professor PII:
S0278-2391(19)31050-X
DOI:
https://doi.org/10.1016/j.joms.2019.08.025
Reference:
YJOMS 58901
To appear in:
Journal of Oral and Maxillofacial Surgery
Received Date: 16 July 2019 Revised Date:
29 August 2019
Accepted Date: 29 August 2019
Please cite this article as: Tsukamoto M, Taura S, Hitosugi T, Yokoyama T, The comparison of the performance of mask ventilation between face masks with and without air cushion., Journal of Oral and Maxillofacial Surgery (2019), doi: https://doi.org/10.1016/j.joms.2019.08.025. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Published by Elsevier Inc on behalf of the American Association of Oral and Maxillofacial Surgeons
Title: The comparison of the performance of mask ventilation between face masks with and without air cushion. Short title: The comparison of mask ventilation between face masks. Key word: face mask; tidal volume; difficult ventilation.
1
Masanori Tsukamoto (DDS, Ph.D., Assistant Professor, email address: [email protected])
2
Shiori Taura (DDS, Graduate student, email address: [email protected])
3
Takashi Hitosugi (DDS, Ph.D., Assistant Professor, email address: [email protected])
3
Takeshi Yokoyama (DDS, Ph.D., Professor, email address: [email protected])
1
Department of Dental Anesthesiology, Kyushu University Hospital, Fukuoka, Japan
2
Department of Dental Anesthesiology, Graduate School of Dental Science, Kyushu University, Fukuoka, Japan 3
Department of Dental Anesthesiology, Faculty of Dental Science, Kyushu University, Fukuoka, Japan
Corresponding author Masanori Tsukamoto Department of Dental Anesthesiology, Kyushu University Hospital, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan Tel: +81 92 642 6480 Fax: +81 92 642 6481 Email: [email protected]
1
Abstract Objectives Mask ventilation is a basic technique for induction of anesthesia. In head and neck surgery, we encountered difficulty in ventilation due to facial deformities. Recently, a new type of face mask without air cushion, QuadraLite face mask [QuadraLite], was developed. The aim of this study was to compare the performance for cases with predicted difficult mask ventilation between the new type face mask and a traditional face mask. Methods This study was a crossover prospective study. Participants were patients (>18 yrs) who underwent oral maxillofacial surgery under general anesthesia. The risk factors of difficult airway were checked. Patients were divided into three groups; Low risk: predicted none or 1 risk factor in predicted difficult mask ventilation, Medium risk: 2 or 3 risk factors and High risk: 4 or more risk factors. Air cushion face mask [Cushion] and the QuadraLite was applied by turns under the setting of pressure-controlled ventilation. The expiratory tidal volumes were compared between these face masks. Results A total of 48 patients were included; 16 in Low risk, 16 in Medium risk and 16 in High risk. Higher expiratory tidal volumes were observed in the QuadraLite compared to the Cushion, although it did not reach to the statistically significant level; 574.3 ± 62.7 mL vs 553.1 ± 60.6 mL in Low risk (p=0.44), 553.1 ± 112.9 mL vs 536.4 ± 114.2 mL in Medium risk (p=0.38), 560.0 ± 98.6 mL vs 548.2 ± 07.1 mL in High risk (p=0.22). In all cases, sufficient ventilation volume was obtained by the QuadraLite. Conclusion The QuadraLite is compact due to no air cushion, and it could provide sufficient mask ventilation as well as traditional face mask with air cushion even in patients with difficult airway.
1
Introduction Mask ventilation is a basic technique for airway management, and maintenance of a patent airway is a primary responsibility of anesthesiologists in general anesthesia [1-3]. However, difficult mask ventilation occurs at a certain frequency, which might lead to permanent brain damage or death. [4-6] The better prediction of difficult mask ventilation could reduce morbidity and mortality by adequate allocation of relevant personnel and/or the use of appropriate devices. [7, 8] In head and neck surgery, we encounter difficulty in mask ventilation due to deformities of facial and pharyngeal structures. A lot of parameters have been used to evaluate difficulty of the airway; Mallampati classification, mouth opening and head and neck extension. [1-4, 6, 8] However, the difficulty of achieving a patent airway varies with anatomical and other individual factors. [9-12] On the other hand, there are several types of facemasks, which vary in their fit to the patient’s face and in their efficiency for gas delivery to the patient. Their fitting efficacy may depend on the patient’s face. In addition, the face mask designs also may influence on mask ventilation performance during induction of anesthesia [11-13]. Recently, a new type of face mask without air cushion, QuadraLite face mask [QuadraLite] (Intersurgical Ltd., Berkshire, England), was appeared, although face masks with air cushion are commonly used in anesthesia. Regardless of the type or design of face masks, it is important to obtain a tight seal with the face. A loose seal due to an improper sized mask usually increases air leaks, and might causes difficult ventilation. [6, 10]. The aim of this study was to compare the performance between the new type face mask and a traditional face mask in the patients with parameters of predicted difficult mask ventilation. 2
Methods This prospective randomized crossover study was approved by the Ethics Committee of Kyushu University Hospital (29-497), and has been registered with the UMIN Clinical Trials Registry (No.000036698). The patients were recruited between January 2018 and November 2018. They were American Society of Anesthesiologists physical status 1 or 2, and underwent elective oral maxillofacial surgery under general anesthesia. Exclusion criteria were the patients with history of cardiac disease, gastric regurgitation, respiratory disease, emergency case and/or an inability to communicate. The risk parameters were checked in preoperative airway assessment for prediction of difficult mask ventilation; male gender, age>45 yrs, BMI>30 kg/m2, history of snoring, limitation of neck movement, lack of teeth, Mallampati class 3 or 4, presence of beard, mouth opening < 30 mm and facial deformation [3, 5, 13]. Patients (20-80 yrs) were divided into three groups according to the numbers of predicted risk factors for mask ventolation; low risk group: predicted 0 or 1 risk factor, medium risk group: 2 or 3 risk factors and high risk group: 4 or more risk factors. The appropriate size of face mask was applied for each patient, and the mask size was noted. Two types of face masks were prepared for this study. One equipped air cushion and another has no air cushon; air cushion face mask [Cushion] (Koo® Medical, Shanghai, China) and no air cushion face mask [QuadraLite] (Fig.1). The patients received no premedication. The patients were taken into the sniffing position with a pillow (5 cm in thickness) ensuring that the lower level of the pillow did not extend beyond the shoulders. The patients were continuously monitored with electrocardiogram (ECG), bispectral index (BIS), arterial oxygen 3
saturation measured by pulse oximetry (SpO2), heart rate (HR) and noninvasive blood pressure (BP). General anesthesia was induced with propofol (1-2 mg/kg), atropine (5 µg/kg), remifentanil (0.1-0.25 µg/kg/min), fentanyl (1-2 µg/kg) and rocuronium (0.6 mg/kg). During evaluation of the performance of the masks, anesthesia was maintained with 1 minimum alveolar concentration (MAC) of inhalational anesthetic in 6 L/min of fresh gas flow and intravenous remifentanil 0.05-0.25 µg/kg/min. After getting sufficient muscle relaxation, the patient was ventilated with a face mask under pressure-controlled ventilation at 15 cmH2O with a rate of 15 breaths per minute with an inspiratory to expiratory time ration of 1:2 and PEEP 4 cmH2O for 3 minutes. After then, another face mask was applied at the same ventilation condition. The order of two face masks was determined by computer randomization. Both face masks were routinely used in our department and they were familiar to us. If it was difficult to obtain chest excursion sufficient to maintain a clinically acceptable end-tidal CO2 capnogram waveform or to maintain SpO2 >90%, an appropriate sized oral airway was inserted. The mask was held with left hand to achieve an adequate expired tidal volume by using EC technique. Anesthesiologist was blinded to the monitor display so that he could not compensate for the mask leak based on the measured values. Respiratory complications such as desaturation, laryngospasm and breath holding were recorded. All recordings were performed by one experienced anesthesiologist, and the data were recorded by independent residents. Based on results from a preliminary, unpublished study by the authors and previous report, a sample size of 14 patients would have 80% power to detect a difference of at least 50% at an α level of 0.05 for each parameter [13]. With a projected dropout rate of 10%, the sample size was finally determined to be 16 4
patients. All statistical analyses were performed using JMP® 11 (SAS Institute Inc., Cary, NC, USA). In the variate analysis, parametric data were analyzed by using a paired t-test. All values are expressed as mean ± standard deviation (SD) or the number (n). P value < 0.05 was considered statistically significant.
5
Results A total of 48 patients completed the study, and the predicted risk factors were presented in Table.1. The anesthesiologist had ventilated by using two face masks with size 3 of all patients. Respiratory complications did not occur for either mask. Some patients had facial deformity; jaw deformity (4 cases), mandibular fracture (2 cases), post-mandibular reconstruction surgery using fibula (3 cases) and submandibular swelling due to postoperative infection (1 case). Neither Cushion nor QuadraLite could provide sufficient mask ventilation in 3 patients in Low risk and 4 patients in High risk. Therefore, oral airway device was inserted to maintain airway. Except these 7 patients, mask ventilation was not difficult. There were no cases with insufficient ventilation only in either mask. The QuadraLite had be inclined to higher expired tidal volumes compared to the Cushion, respectively; 574.3 ± 62.7 mL [range: 450-680 mL] vs 553.1 ± 60.6 mL [range: 470-710 mL] in Low risk (p=0.44), 553.1 ± 112.9 mL [range: 390-760 mL] vs 536.4 ± 114.2 mL [range: 320-760 mL] in Medium risk (p=0.38), 560.0 ± 98.6 mL [range: 412-810 mL] vs 548.2 ± 07.1 mL [range: 388-790 mL] in High risk (p=0.22) ( Fig.2).
6
Discussion Our results showed that the QuadraLite is as useful as a traditional face mask with air cushion. In fact, the mean volume of mask ventilation of the QuadraLite was larger by 10-20 mL than that of Cushion mask, although it did not reach statistically significant level. Mask ventilation is very important as life threatening hypoxemia may occur during induction of anesthesia, if delivery of oxygen into the alveoli of the lung became insufficient. [4] Previous reports described that average oxygen consumption in a healthy patient is around to 250 mL/min [14-16]. However, it depends on patient physique or metabolic conditions. Therefore, around 300 mL/min of minute volume should be provided during mask ventilation, although hyper-ventilation also should be avoided. The improvement in tidal volume could be attributed to anatomical and physiological factors. During induction of anesthesia, airway obstruction may occur as the tongue falls back and/or pharyngeal space become narrow due to relaxation of the pharyngeal muscles. [3, 6] Difficult mask ventilation is not well defined and is subject to physician variability, but they occur in 0.01–1.4%. [1, 2, 17] In addition, the more risky condition could make clinical situations worse. [1, 6] Facial deformity due to surgical resection of tumors or inflammational swelling may lead to an impossible mask fit and/or mask ventilation. [3, 6, 18, 19] The history of snoring, limitation of neck extension and/or mouth opening may make the airway difficult. [1-4] Anesthesiologists often become nervous about air leak due to insufficient fitting between the face and the face mask. There are several factors that may contribute to the mask leak: the operator's performance including hand size and facial anatomy of the patient [4, 9, 12, 13]. There are some predictors for difficult airway. Mallampati grade is highly related to difficult ventilation. The higher grade indicates the longer soft palate and narrow space between the floor of the mouth and soft 7
palate. [1] Age has been found to be closely correlated with an increased pharyngeal resistance to airflow in men. [3] A reduced posterior airway space behind the base of the tongue is associated with an increased BMI [2- 4]. Upper airway obstruction can occur after induction of general anesthesia with posterior displacements of the soft palate and base of tongue. Getting back of the epiglottis may lead to airway obstruction. Lack of teeth and the presence of a beard were also associated with difficult mask ventilation, decreasing the tight seal of the face mask and increasing air leakage around the mask with difficult ventilation [3].
However, they could be overcome with maneuvers such as jaw thrust or oral airway with or without presence of air cushion in face mask. The impact of the mask design on the quality of the mask seal has been examined, and the performance of disposable facemasks with a soft cuff and body was better than that of a reusable black rubber mask [10]. In the QuadraLite, mask ventilation was easier for female anesthesiologists, smaller in stature, hand size and/or weaker in grip power. As the QuadraLite is compact due to no air cushion, we could achieve better and easier tight air seal with the face. In our study, we could get sufficient expiratory tidal volume even in the cases with many risk factors of difficult mask ventilation. In this study, all of the patients were ventilated by the same anesthesiologist; the widely adopted classic EC technique was used as an active comparator for the adult mask [4, 12, 13, 20]. The EC technique of mask holding is used to hold the mask over the patient’s face in a way that the little finger provides jaw thrust, while the ring and middle fingers rest softly on the rim of the mandible forming an E shape, while the thumb and the index finger form C shape attempting to secure the mask tightly around the patient’s mouth and nose. Various mask types and mask techniques have been investigated in diverse clinical situations to manage 8
difficult mask ventilation [13]. A 2-handed ventilation technique compared with 1-handed is often used to compensate for gas leakage around the mask in the case of difficult airway, but this could inflate the stomach and increase the risk of regurgitation and/or pulmonary aspiration [4, 13]. In this study, muscle relaxant was administered for effective and safest practice. It was previously reported that muscle relaxant does not worsen the quality of facemask ventilation [5, 6, 14, 15]. Preferably, it could improve face mask ventilation by facilitating optimal sniffing position and jaw thrust [5, 17]. In this study, the peak airway pressure was kept constant (15 cmH2O) to minimize the risk of gastric insufflation [15]. Our study has several limitations. The study included only one size of masks, and did not attempt to evaluate another size of face masks. Appropriate mask size may be obtained by ensuring that the selected mask base rests on mandibular margin while the mask apex rests at the nasion of the patient[12]. However, it is likely that similar results would be obtained when comparing the other size.
Conclusion: The QuadraLite could provide sufficient mask ventilation as well as a traditional face mask with air cushion even in patients with difficult airway.
9
Reference 1 Yildiz TS, Solak M, Toker K,The incidence and risk factors of difficult mask ventilation, J Anesth, 2005;19(1):7-11. 2 Carron M, Predicting difficult mask ventilation: a crucial point of airway management in obese patients, Minerva Anestesiol, 2014;80(2):143-5. 3 Langeron O, Masso E, Huraux C, Guggiari M, Bianchi A, Coriat P, Riou B,Prediction of difficult mask ventilation. Anesthesiology, 2000;92(5):1229-36. 4 Japanese Society of Anesthesiologists, JSA airway management guideline 2014: to improve the safety of induction of anesthesia, J Anesth. 2014;28(4):482-93. 5 Fei M, Blair JL, Rice MJ, Edwards DA, Liang Y, Pilla MA, Shotwell MS, Jiang Y, Comparison of effectiveness of two commonly used two-handed mask ventilation techniques on unconscious apnoeic obese adults, Br J Anaesth, 2017;118(4):618-624. 6 El-Orbany M, Woehlck HJ, Difficult mask ventilation, Anesth Analg, 2009;109(6):1870-80. 7 Finer NN,, Rich W, Craft A, Henderson C, Comparison of methods of bag and mask ventilation for neonatal resuscitation, Resuscitation, 2001;49(3):299-305. 8 Kheterpal S, Martin L, Shanks AM, Tremper KK, Prediction and outcomes of impossible mask ventilation: a review of 50,000 anesthetics, Anesthesiology, 2009;110(4):891-7. 9 Nandalan SP, Waters JH, A comparison of three facemasks used during the induction of general anaesthesia, Eur J Anaesthesiol, 2006;23(10):869-73. 10 Redfern D, Rassam S, Stacey MR, Mecklenburgh JS, Comparison of face masks in the bag-mask ventilation of a manikin. Eur J Anaesthesiol, 2006;23(2):169-72. 11 Na JU, Han SK, Choi PC, Cho JH, Shin DH, Influence of face mask design on bag-valve-mask ventilation performance: a randomized simulation study. Acta Anaesthesiol Scand. 2013;57(9):1186-92. 12 Umesh G, Krishna R, Chaudhuri S, Tim TJ, Shwethapriya R, E-O technique is superior to E-C technique in manikins during single person bag mask ventilation performed by novices. J Clin Monit Comput, 2014;28(3):269-73. 13 Yazicioğlu D, Baran I, Uzumcugil F, Ozturk I, Utebey G, Sayın MM, Oral mask ventilation is more effective than face mask ventilation after nasal surgery, J Clin Anesth, 2016;31:64-70. 10
14 Nimmagadda U, Salem MR, Crystal GJ, Preoxygenation: Physiologic Basis, Benefits, and Potential Risks. Anesth Analg, 2017;124(2):507-517. 15 Priebe HJ, Should anesthesiologists have to confirm effective facemask ventilation before administering the muscle relaxant? J Anesth. 2016;30(1):132-7. 16 Sachdeva R, Kannan TR, Mendonca C, Patteril M, Evaluation of changes in tidal volume during mask ventilation following administration of neuromuscular blocking drugs, Anaesthesia. 2014;69(8):826-31. 17 Cattano D, Panicucci E, Paolicchi A, Forfori F, Giunta F, Hagberg C. Risk factors assessment of the difficult airway: an italian survey of 1956 patients. Anesth Analg. 2004;99(6):1774-9, 18 Aiello G1, Metcalf I, Anaesthetic implications of temporomandibular joint disease. Can J Anaesth. 1992;39(6):610-6. 19 Tsukamoto M, Hitosugi T,Yokoyama T, Awake fiberoptic nasotracheal intubation for patients with difficult airway, J Dent Anesth Pain Med. 2018;18(5):301-304. 20 Umesh G, Krishna R, Chaudhuri S, Tim TJ, Shwethapriya R,E-O technique is superior to E-C technique in manikins during single person bag mask ventilation performed by novices, J Clin Monit Comput. 2014;28(3):269-73.
11
Table Table.1 Demographic characteristics of patients and the list of risk factor in predicted difficult ventilation. Low risk (n=16)
Medium risk (n=16)
High risk (n=16)
5/11
10/6
13/3
Age (yrs)
29.3 ± 11.7
53.9 ± 19.1
62.1 ± 15.7
Height (cm)
163.1 ± 8.5
165.3 ± 8.9
162.3 ± 7.2
Weight (kg)
55.1 ± 6.7
61.9 ± 10.6
57.8 ± 10.5
BMI (kg/m2)
20.7 ± 1.6
22.7 ± 3.3
22.0 ± 3.9
Gender (M/F)
The number of risk factor of difficult ventilation (n=0/1/2/3/4/5/6)
2/14/0/0/0/0/0 0/0/6/10/0/0/0 0/0/0/0/12/2/2
Age>45 (yrs)
( n=2)
( n=11)
( n=13)
History of snoring
( n=0)
( n=2)
( n=3)
BMI > 30( kg/m2)
( n= 0)
( n= 1)
( n=0)
Lack of teeth
( n=0)
( n=6)
( n=9)
Presence of beard
( n=0)
( n=0)
( n=0)
( n=2/2)
( n=8/2)
( n=4/9)
Mouth opening < 30 mm
( n=1)
( n=0)
( n=7)
Limitation of neck extension
( n=0)
( n=0)
( n=2)
Facial deformity
( n=2)
( n=2)
( n=7)
Mallampati classification (3/4)
12
Figures Fig.1 Two types of face mask: (1) QuadraLite face mask (Intersurgical LTD., Berkshire, England) and (2) Air cushion face mask (Koo® Medical, Shanghai, China).
13
Fig.2 The comparison of expired tidal volume in each risk; Low risk (n=16), Medium risk (n=16) and High risk (n=16) between two face masks.
QuadraLite; QuadraLite face mask: Intersurgical Ltd., Berkshire, England. Cushion; Air cushion face mask: Koo® Medical, Shanghai, China. Low risk: predicted none or 1 risk factor in predicted difficult mask ventilation, Medium risk: 2 or 3 risk factors and High risk: 4 or more risk factors.
A paired t-test. All values are expressed as mean ± standard deviation.
The QuadraLite had be inclined to higher expired tidal volumes compared to Cushion. In Low risk: 574.3 ± 62.7 mL [range: 450-680 mL] vs 553.1 ± 60.6 mL [range: 470-710 mL], p=0.44. In Medium risk 553.1 ± 112.9 mL [range: 390-760 mL] vs 536.4 ± 114.2 mL [range: 320-760 mL], p=0.38. In High risk 560.0 ± 98.6 mL [range: 412-810 mL] vs 548.2 ± 07.1 mL [range: 388-790 mL], p=0.22.
14
S0278-2391(19)31050-X
DOI:
https://doi.org/10.1016/j.joms.2019.08.025
Reference:
YJOMS 58901
To appear in:
Journal of Oral and Maxillofacial Surgery
Received Date: 16 July 2019 Revised Date:
29 August 2019
Accepted Date: 29 August 2019
Please cite this article as: Tsukamoto M, Taura S, Hitosugi T, Yokoyama T, The comparison of the performance of mask ventilation between face masks with and without air cushion., Journal of Oral and Maxillofacial Surgery (2019), doi: https://doi.org/10.1016/j.joms.2019.08.025. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Published by Elsevier Inc on behalf of the American Association of Oral and Maxillofacial Surgeons
Title: The comparison of the performance of mask ventilation between face masks with and without air cushion. Short title: The comparison of mask ventilation between face masks. Key word: face mask; tidal volume; difficult ventilation.
1
Masanori Tsukamoto (DDS, Ph.D., Assistant Professor, email address: [email protected])
2
Shiori Taura (DDS, Graduate student, email address: [email protected])
3
Takashi Hitosugi (DDS, Ph.D., Assistant Professor, email address: [email protected])
3
Takeshi Yokoyama (DDS, Ph.D., Professor, email address: [email protected])
1
Department of Dental Anesthesiology, Kyushu University Hospital, Fukuoka, Japan
2
Department of Dental Anesthesiology, Graduate School of Dental Science, Kyushu University, Fukuoka, Japan 3
Department of Dental Anesthesiology, Faculty of Dental Science, Kyushu University, Fukuoka, Japan
Corresponding author Masanori Tsukamoto Department of Dental Anesthesiology, Kyushu University Hospital, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan Tel: +81 92 642 6480 Fax: +81 92 642 6481 Email: [email protected]
1
Abstract Objectives Mask ventilation is a basic technique for induction of anesthesia. In head and neck surgery, we encountered difficulty in ventilation due to facial deformities. Recently, a new type of face mask without air cushion, QuadraLite face mask [QuadraLite], was developed. The aim of this study was to compare the performance for cases with predicted difficult mask ventilation between the new type face mask and a traditional face mask. Methods This study was a crossover prospective study. Participants were patients (>18 yrs) who underwent oral maxillofacial surgery under general anesthesia. The risk factors of difficult airway were checked. Patients were divided into three groups; Low risk: predicted none or 1 risk factor in predicted difficult mask ventilation, Medium risk: 2 or 3 risk factors and High risk: 4 or more risk factors. Air cushion face mask [Cushion] and the QuadraLite was applied by turns under the setting of pressure-controlled ventilation. The expiratory tidal volumes were compared between these face masks. Results A total of 48 patients were included; 16 in Low risk, 16 in Medium risk and 16 in High risk. Higher expiratory tidal volumes were observed in the QuadraLite compared to the Cushion, although it did not reach to the statistically significant level; 574.3 ± 62.7 mL vs 553.1 ± 60.6 mL in Low risk (p=0.44), 553.1 ± 112.9 mL vs 536.4 ± 114.2 mL in Medium risk (p=0.38), 560.0 ± 98.6 mL vs 548.2 ± 07.1 mL in High risk (p=0.22). In all cases, sufficient ventilation volume was obtained by the QuadraLite. Conclusion The QuadraLite is compact due to no air cushion, and it could provide sufficient mask ventilation as well as traditional face mask with air cushion even in patients with difficult airway.
1
Introduction Mask ventilation is a basic technique for airway management, and maintenance of a patent airway is a primary responsibility of anesthesiologists in general anesthesia [1-3]. However, difficult mask ventilation occurs at a certain frequency, which might lead to permanent brain damage or death. [4-6] The better prediction of difficult mask ventilation could reduce morbidity and mortality by adequate allocation of relevant personnel and/or the use of appropriate devices. [7, 8] In head and neck surgery, we encounter difficulty in mask ventilation due to deformities of facial and pharyngeal structures. A lot of parameters have been used to evaluate difficulty of the airway; Mallampati classification, mouth opening and head and neck extension. [1-4, 6, 8] However, the difficulty of achieving a patent airway varies with anatomical and other individual factors. [9-12] On the other hand, there are several types of facemasks, which vary in their fit to the patient’s face and in their efficiency for gas delivery to the patient. Their fitting efficacy may depend on the patient’s face. In addition, the face mask designs also may influence on mask ventilation performance during induction of anesthesia [11-13]. Recently, a new type of face mask without air cushion, QuadraLite face mask [QuadraLite] (Intersurgical Ltd., Berkshire, England), was appeared, although face masks with air cushion are commonly used in anesthesia. Regardless of the type or design of face masks, it is important to obtain a tight seal with the face. A loose seal due to an improper sized mask usually increases air leaks, and might causes difficult ventilation. [6, 10]. The aim of this study was to compare the performance between the new type face mask and a traditional face mask in the patients with parameters of predicted difficult mask ventilation. 2
Methods This prospective randomized crossover study was approved by the Ethics Committee of Kyushu University Hospital (29-497), and has been registered with the UMIN Clinical Trials Registry (No.000036698). The patients were recruited between January 2018 and November 2018. They were American Society of Anesthesiologists physical status 1 or 2, and underwent elective oral maxillofacial surgery under general anesthesia. Exclusion criteria were the patients with history of cardiac disease, gastric regurgitation, respiratory disease, emergency case and/or an inability to communicate. The risk parameters were checked in preoperative airway assessment for prediction of difficult mask ventilation; male gender, age>45 yrs, BMI>30 kg/m2, history of snoring, limitation of neck movement, lack of teeth, Mallampati class 3 or 4, presence of beard, mouth opening < 30 mm and facial deformation [3, 5, 13]. Patients (20-80 yrs) were divided into three groups according to the numbers of predicted risk factors for mask ventolation; low risk group: predicted 0 or 1 risk factor, medium risk group: 2 or 3 risk factors and high risk group: 4 or more risk factors. The appropriate size of face mask was applied for each patient, and the mask size was noted. Two types of face masks were prepared for this study. One equipped air cushion and another has no air cushon; air cushion face mask [Cushion] (Koo® Medical, Shanghai, China) and no air cushion face mask [QuadraLite] (Fig.1). The patients received no premedication. The patients were taken into the sniffing position with a pillow (5 cm in thickness) ensuring that the lower level of the pillow did not extend beyond the shoulders. The patients were continuously monitored with electrocardiogram (ECG), bispectral index (BIS), arterial oxygen 3
saturation measured by pulse oximetry (SpO2), heart rate (HR) and noninvasive blood pressure (BP). General anesthesia was induced with propofol (1-2 mg/kg), atropine (5 µg/kg), remifentanil (0.1-0.25 µg/kg/min), fentanyl (1-2 µg/kg) and rocuronium (0.6 mg/kg). During evaluation of the performance of the masks, anesthesia was maintained with 1 minimum alveolar concentration (MAC) of inhalational anesthetic in 6 L/min of fresh gas flow and intravenous remifentanil 0.05-0.25 µg/kg/min. After getting sufficient muscle relaxation, the patient was ventilated with a face mask under pressure-controlled ventilation at 15 cmH2O with a rate of 15 breaths per minute with an inspiratory to expiratory time ration of 1:2 and PEEP 4 cmH2O for 3 minutes. After then, another face mask was applied at the same ventilation condition. The order of two face masks was determined by computer randomization. Both face masks were routinely used in our department and they were familiar to us. If it was difficult to obtain chest excursion sufficient to maintain a clinically acceptable end-tidal CO2 capnogram waveform or to maintain SpO2 >90%, an appropriate sized oral airway was inserted. The mask was held with left hand to achieve an adequate expired tidal volume by using EC technique. Anesthesiologist was blinded to the monitor display so that he could not compensate for the mask leak based on the measured values. Respiratory complications such as desaturation, laryngospasm and breath holding were recorded. All recordings were performed by one experienced anesthesiologist, and the data were recorded by independent residents. Based on results from a preliminary, unpublished study by the authors and previous report, a sample size of 14 patients would have 80% power to detect a difference of at least 50% at an α level of 0.05 for each parameter [13]. With a projected dropout rate of 10%, the sample size was finally determined to be 16 4
patients. All statistical analyses were performed using JMP® 11 (SAS Institute Inc., Cary, NC, USA). In the variate analysis, parametric data were analyzed by using a paired t-test. All values are expressed as mean ± standard deviation (SD) or the number (n). P value < 0.05 was considered statistically significant.
5
Results A total of 48 patients completed the study, and the predicted risk factors were presented in Table.1. The anesthesiologist had ventilated by using two face masks with size 3 of all patients. Respiratory complications did not occur for either mask. Some patients had facial deformity; jaw deformity (4 cases), mandibular fracture (2 cases), post-mandibular reconstruction surgery using fibula (3 cases) and submandibular swelling due to postoperative infection (1 case). Neither Cushion nor QuadraLite could provide sufficient mask ventilation in 3 patients in Low risk and 4 patients in High risk. Therefore, oral airway device was inserted to maintain airway. Except these 7 patients, mask ventilation was not difficult. There were no cases with insufficient ventilation only in either mask. The QuadraLite had be inclined to higher expired tidal volumes compared to the Cushion, respectively; 574.3 ± 62.7 mL [range: 450-680 mL] vs 553.1 ± 60.6 mL [range: 470-710 mL] in Low risk (p=0.44), 553.1 ± 112.9 mL [range: 390-760 mL] vs 536.4 ± 114.2 mL [range: 320-760 mL] in Medium risk (p=0.38), 560.0 ± 98.6 mL [range: 412-810 mL] vs 548.2 ± 07.1 mL [range: 388-790 mL] in High risk (p=0.22) ( Fig.2).
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Discussion Our results showed that the QuadraLite is as useful as a traditional face mask with air cushion. In fact, the mean volume of mask ventilation of the QuadraLite was larger by 10-20 mL than that of Cushion mask, although it did not reach statistically significant level. Mask ventilation is very important as life threatening hypoxemia may occur during induction of anesthesia, if delivery of oxygen into the alveoli of the lung became insufficient. [4] Previous reports described that average oxygen consumption in a healthy patient is around to 250 mL/min [14-16]. However, it depends on patient physique or metabolic conditions. Therefore, around 300 mL/min of minute volume should be provided during mask ventilation, although hyper-ventilation also should be avoided. The improvement in tidal volume could be attributed to anatomical and physiological factors. During induction of anesthesia, airway obstruction may occur as the tongue falls back and/or pharyngeal space become narrow due to relaxation of the pharyngeal muscles. [3, 6] Difficult mask ventilation is not well defined and is subject to physician variability, but they occur in 0.01–1.4%. [1, 2, 17] In addition, the more risky condition could make clinical situations worse. [1, 6] Facial deformity due to surgical resection of tumors or inflammational swelling may lead to an impossible mask fit and/or mask ventilation. [3, 6, 18, 19] The history of snoring, limitation of neck extension and/or mouth opening may make the airway difficult. [1-4] Anesthesiologists often become nervous about air leak due to insufficient fitting between the face and the face mask. There are several factors that may contribute to the mask leak: the operator's performance including hand size and facial anatomy of the patient [4, 9, 12, 13]. There are some predictors for difficult airway. Mallampati grade is highly related to difficult ventilation. The higher grade indicates the longer soft palate and narrow space between the floor of the mouth and soft 7
palate. [1] Age has been found to be closely correlated with an increased pharyngeal resistance to airflow in men. [3] A reduced posterior airway space behind the base of the tongue is associated with an increased BMI [2- 4]. Upper airway obstruction can occur after induction of general anesthesia with posterior displacements of the soft palate and base of tongue. Getting back of the epiglottis may lead to airway obstruction. Lack of teeth and the presence of a beard were also associated with difficult mask ventilation, decreasing the tight seal of the face mask and increasing air leakage around the mask with difficult ventilation [3].
However, they could be overcome with maneuvers such as jaw thrust or oral airway with or without presence of air cushion in face mask. The impact of the mask design on the quality of the mask seal has been examined, and the performance of disposable facemasks with a soft cuff and body was better than that of a reusable black rubber mask [10]. In the QuadraLite, mask ventilation was easier for female anesthesiologists, smaller in stature, hand size and/or weaker in grip power. As the QuadraLite is compact due to no air cushion, we could achieve better and easier tight air seal with the face. In our study, we could get sufficient expiratory tidal volume even in the cases with many risk factors of difficult mask ventilation. In this study, all of the patients were ventilated by the same anesthesiologist; the widely adopted classic EC technique was used as an active comparator for the adult mask [4, 12, 13, 20]. The EC technique of mask holding is used to hold the mask over the patient’s face in a way that the little finger provides jaw thrust, while the ring and middle fingers rest softly on the rim of the mandible forming an E shape, while the thumb and the index finger form C shape attempting to secure the mask tightly around the patient’s mouth and nose. Various mask types and mask techniques have been investigated in diverse clinical situations to manage 8
difficult mask ventilation [13]. A 2-handed ventilation technique compared with 1-handed is often used to compensate for gas leakage around the mask in the case of difficult airway, but this could inflate the stomach and increase the risk of regurgitation and/or pulmonary aspiration [4, 13]. In this study, muscle relaxant was administered for effective and safest practice. It was previously reported that muscle relaxant does not worsen the quality of facemask ventilation [5, 6, 14, 15]. Preferably, it could improve face mask ventilation by facilitating optimal sniffing position and jaw thrust [5, 17]. In this study, the peak airway pressure was kept constant (15 cmH2O) to minimize the risk of gastric insufflation [15]. Our study has several limitations. The study included only one size of masks, and did not attempt to evaluate another size of face masks. Appropriate mask size may be obtained by ensuring that the selected mask base rests on mandibular margin while the mask apex rests at the nasion of the patient[12]. However, it is likely that similar results would be obtained when comparing the other size.
Conclusion: The QuadraLite could provide sufficient mask ventilation as well as a traditional face mask with air cushion even in patients with difficult airway.
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Reference 1 Yildiz TS, Solak M, Toker K,The incidence and risk factors of difficult mask ventilation, J Anesth, 2005;19(1):7-11. 2 Carron M, Predicting difficult mask ventilation: a crucial point of airway management in obese patients, Minerva Anestesiol, 2014;80(2):143-5. 3 Langeron O, Masso E, Huraux C, Guggiari M, Bianchi A, Coriat P, Riou B,Prediction of difficult mask ventilation. Anesthesiology, 2000;92(5):1229-36. 4 Japanese Society of Anesthesiologists, JSA airway management guideline 2014: to improve the safety of induction of anesthesia, J Anesth. 2014;28(4):482-93. 5 Fei M, Blair JL, Rice MJ, Edwards DA, Liang Y, Pilla MA, Shotwell MS, Jiang Y, Comparison of effectiveness of two commonly used two-handed mask ventilation techniques on unconscious apnoeic obese adults, Br J Anaesth, 2017;118(4):618-624. 6 El-Orbany M, Woehlck HJ, Difficult mask ventilation, Anesth Analg, 2009;109(6):1870-80. 7 Finer NN,, Rich W, Craft A, Henderson C, Comparison of methods of bag and mask ventilation for neonatal resuscitation, Resuscitation, 2001;49(3):299-305. 8 Kheterpal S, Martin L, Shanks AM, Tremper KK, Prediction and outcomes of impossible mask ventilation: a review of 50,000 anesthetics, Anesthesiology, 2009;110(4):891-7. 9 Nandalan SP, Waters JH, A comparison of three facemasks used during the induction of general anaesthesia, Eur J Anaesthesiol, 2006;23(10):869-73. 10 Redfern D, Rassam S, Stacey MR, Mecklenburgh JS, Comparison of face masks in the bag-mask ventilation of a manikin. Eur J Anaesthesiol, 2006;23(2):169-72. 11 Na JU, Han SK, Choi PC, Cho JH, Shin DH, Influence of face mask design on bag-valve-mask ventilation performance: a randomized simulation study. Acta Anaesthesiol Scand. 2013;57(9):1186-92. 12 Umesh G, Krishna R, Chaudhuri S, Tim TJ, Shwethapriya R, E-O technique is superior to E-C technique in manikins during single person bag mask ventilation performed by novices. J Clin Monit Comput, 2014;28(3):269-73. 13 Yazicioğlu D, Baran I, Uzumcugil F, Ozturk I, Utebey G, Sayın MM, Oral mask ventilation is more effective than face mask ventilation after nasal surgery, J Clin Anesth, 2016;31:64-70. 10
14 Nimmagadda U, Salem MR, Crystal GJ, Preoxygenation: Physiologic Basis, Benefits, and Potential Risks. Anesth Analg, 2017;124(2):507-517. 15 Priebe HJ, Should anesthesiologists have to confirm effective facemask ventilation before administering the muscle relaxant? J Anesth. 2016;30(1):132-7. 16 Sachdeva R, Kannan TR, Mendonca C, Patteril M, Evaluation of changes in tidal volume during mask ventilation following administration of neuromuscular blocking drugs, Anaesthesia. 2014;69(8):826-31. 17 Cattano D, Panicucci E, Paolicchi A, Forfori F, Giunta F, Hagberg C. Risk factors assessment of the difficult airway: an italian survey of 1956 patients. Anesth Analg. 2004;99(6):1774-9, 18 Aiello G1, Metcalf I, Anaesthetic implications of temporomandibular joint disease. Can J Anaesth. 1992;39(6):610-6. 19 Tsukamoto M, Hitosugi T,Yokoyama T, Awake fiberoptic nasotracheal intubation for patients with difficult airway, J Dent Anesth Pain Med. 2018;18(5):301-304. 20 Umesh G, Krishna R, Chaudhuri S, Tim TJ, Shwethapriya R,E-O technique is superior to E-C technique in manikins during single person bag mask ventilation performed by novices, J Clin Monit Comput. 2014;28(3):269-73.
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Table Table.1 Demographic characteristics of patients and the list of risk factor in predicted difficult ventilation. Low risk (n=16)
Medium risk (n=16)
High risk (n=16)
5/11
10/6
13/3
Age (yrs)
29.3 ± 11.7
53.9 ± 19.1
62.1 ± 15.7
Height (cm)
163.1 ± 8.5
165.3 ± 8.9
162.3 ± 7.2
Weight (kg)
55.1 ± 6.7
61.9 ± 10.6
57.8 ± 10.5
BMI (kg/m2)
20.7 ± 1.6
22.7 ± 3.3
22.0 ± 3.9
Gender (M/F)
The number of risk factor of difficult ventilation (n=0/1/2/3/4/5/6)
2/14/0/0/0/0/0 0/0/6/10/0/0/0 0/0/0/0/12/2/2
Age>45 (yrs)
( n=2)
( n=11)
( n=13)
History of snoring
( n=0)
( n=2)
( n=3)
BMI > 30( kg/m2)
( n= 0)
( n= 1)
( n=0)
Lack of teeth
( n=0)
( n=6)
( n=9)
Presence of beard
( n=0)
( n=0)
( n=0)
( n=2/2)
( n=8/2)
( n=4/9)
Mouth opening < 30 mm
( n=1)
( n=0)
( n=7)
Limitation of neck extension
( n=0)
( n=0)
( n=2)
Facial deformity
( n=2)
( n=2)
( n=7)
Mallampati classification (3/4)
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Figures Fig.1 Two types of face mask: (1) QuadraLite face mask (Intersurgical LTD., Berkshire, England) and (2) Air cushion face mask (Koo® Medical, Shanghai, China).
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Fig.2 The comparison of expired tidal volume in each risk; Low risk (n=16), Medium risk (n=16) and High risk (n=16) between two face masks.
QuadraLite; QuadraLite face mask: Intersurgical Ltd., Berkshire, England. Cushion; Air cushion face mask: Koo® Medical, Shanghai, China. Low risk: predicted none or 1 risk factor in predicted difficult mask ventilation, Medium risk: 2 or 3 risk factors and High risk: 4 or more risk factors.
A paired t-test. All values are expressed as mean ± standard deviation.
The QuadraLite had be inclined to higher expired tidal volumes compared to Cushion. In Low risk: 574.3 ± 62.7 mL [range: 450-680 mL] vs 553.1 ± 60.6 mL [range: 470-710 mL], p=0.44. In Medium risk 553.1 ± 112.9 mL [range: 390-760 mL] vs 536.4 ± 114.2 mL [range: 320-760 mL], p=0.38. In High risk 560.0 ± 98.6 mL [range: 412-810 mL] vs 548.2 ± 07.1 mL [range: 388-790 mL], p=0.22.
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