- Email: [email protected]
A novel method for epistaxis management: Randomized clinical trial comparing nose clip with manual compression
Accepted Manuscript Procalcitonin and D-dimer in predicting 28-day-mortality rate and severity of sepsis based on SOFA score
Mehdi Momeni, Elnaz Vahidi, Javad Safavi, Morteza Saeedi PII: DOI: Reference:
S0735-6757(17)30555-7 doi: 10.1016/j.ajem.2017.07.025 YAJEM 56811
To appear in: Received date: Revised date: Accepted date:
18 June 2017 4 July 2017 6 July 2017
Please cite this article as: Mehdi Momeni, Elnaz Vahidi, Javad Safavi, Morteza Saeedi , Procalcitonin and D-dimer in predicting 28-day-mortality rate and severity of sepsis based on SOFA score, (2017), doi: 10.1016/j.ajem.2017.07.025
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. 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.
ACCEPTED MANUSCRIPT Procalcitonin and D-dimer in predicting 28-day-mortality rate and severity of sepsis based on SOFA score Mehdi Momeni , MD ; Assistant Professor of Emergency Medicine, Emergency Medicine Research Center, Shariati Hospital; Emergency Medicine Department, Tehran University of Medical Sciences, Tehran, Iran
IP
T
Elnaz Vahidi, MD ; Assistant Professor of Emergency Medicine, Emergency Medicine Research Center, Shariati Hospital, Emergency Medicine Department, Tehran University of Medical Sciences, Tehran, Iran
US
CR
Javad Safavi, MD ; Emergency Medicine Department, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran
AN
Morteza Saeedi, MD; Associate Professor of Emergency Medicine, Emergency Medicine Research Center, Shariati Hospital; Emergency Medicine Department, Tehran University of Medical Sciences, Tehran, Iran
M
Corresponding author: Morteza Saeedi, MD ; Tehran University of Medical Sceinces, Prehospital Emergency Research Center, Shariati Hospital.
ED
North Amirabad street Tehran Iran Tel: 982184902719; Fax: 982188633039
PT
[email protected]
CE
Short running title: Procalcitonin and D-dimer in predicting mortality rate
AC
We have not funding source Word count: 2744
Trail was registered in www.irct.ir and trail number is IRCT201408068872N5
Author’s contributions: Momeni M; study design and supervision, Safavi J; data gathering and analysis, Vahidi E; data analysis and drafting, Saeedi M; critical revision
1
ACCEPTED MANUSCRIPT Epistaxis is a common complaint in patients presenting to Emergency Department with the annual prevalence of about 11 % [1, 2]. Sixty percent of population experience epistaxis at least once during life [3, 4]. Annually, 14.9 out of 10000 persons need medical care for epistaxis and among these, 1.6 are admitted [5]. Eighty to ninety percent of epistaxis is originated from anterior nasal cavity [6],
T
Direct compression of the cartilaginous part of the nose for 10 – 15 minutes is a
IP
simple and effective way to control epistaxis with success rate up to 65% [7],
CR
however; it is often missed in epistaxis management and the needed time is not
US
considered by the patient [8].
The application of direct pressure with a correct method and enough time can
may prevent their adverse events [9].
AN
easily obviate the need for further aggressive and expensive interventions and it
AC
CE
PT
ED
M
It is supposed that patients do not apply manual compression constantly for enough time, therefore nose clips may have better success rate because they are not in need of patients’ cooperation.
2
ACCEPTED MANUSCRIPT This study is a randomized clinical trial conducted in Shahid Rahnemoon Hospital Emergency Department from January 2016 to July 2016. The study was approved by Ethics Committee of Shahid Sadoughi University of Medical Sciences. Patients triaged with chief complaint of epistaxis were visited by the physicians in
T
charge of the study and eligible patients were selected. All the assistants involved
IP
in the study were trained to glean the required data.
CR
Patients older than 16 years presented to the Emergency Department with active epistaxis of anterior origin were included in the study.
US
Patients were excluded from the study if there were traumatic or post-surgery
AN
epistaxis, bleeding disorders or anticoagulant use, intervention for controlling epistaxis in recent six months, posterior epistaxis, hemodynamic instability, upper
M
respiratory tract infection, association with a significant complaint (e.g. chest pain), and septal deviation.
ED
After written informed consent, patients eligible for the study was randomized into intervention group (nose clips) and control group (manual compression After
PT
allocation, demographic information of the patients was recorded in a prepared
CE
form. Severity of epistaxis was defined as, no bleeding (1), spotting (2), oozing (3) and severe blood flow (4).
AC
After clearing the clots by blowing the nose, patients were asked to sit on a chair and have sniffing position. In intervention group, nose clip by the nurse, and in control group manual compression by the patient were applied to the cartilaginous part of the nose for 15 minutes. Then the compression was relieved and bleeding severity was assessed and recorded. If bleeding did not stop, the next step was cauterization of bleeding site, if visible, or anterior nasal tampon. If these measures were not successful, the next step was 3
ACCEPTED MANUSCRIPT ENT consultation. Finally, patients satisfaction from the treatment was measured via Likert scale (strongly satisfied, satisfied, no idea, dissatisfied, strongly dissatisfied) Length of stay in the emergency department was measured from the admittion and
T
disposition time and recorded.
AN
US
CR
IP
Twenty six of 92 patients were excluded from the study and the remaining 66 were randomly allocated to two groups of 33 patients. Finally, 30 patients in group A (nose clip) and 31 patients in group B (manual compression) were treated and analyzed (figure 1). Age, sex, and epistaxis severity before intervention were the same in both groups (table 1).
M
Both interventions seemed successful in controlling epistaxis (p value: 0.000) and epistaxis was controlled to full stop (50.8) or spotting (19.7) in 70.5 % of patients.
ED
Nose clip was better in controlling epistaxis especially in severe epistaxis (p value: 0.008). ENT consultations were ordered more in manual compression group, but it
PT
was not statistically significant (p value: 0.8). Emergency Department stays in nose
CE
clip group was less than manual compression (p value: 0.000). Satisfaction was higher in nose clip group (p value: 0.000).
AC
As the study interventions were nose clip and manual compression, blinding of the patients was impossible. Nose clip used in this study applies constant bilateral compression to the cartilaginous part of the nose. It had better success rate than manual compression to fully stop the bleeding (66.7 % versus 35.5 %). Only 1 patient (3.3%) had severe blood flow after applying nose clip much less than control (11 patients [35.5%]). It is supposed that this difference in controlling epistaxis is due to dependency of manual compression to patient’s cooperation. 4
ACCEPTED MANUSCRIPT In control group, further invasive and more time consuming treatment methods increased the length of stay in the Emergency Department. It seems that owing to better controlling of epistaxis, shorter length of stay, and less ENT consultation and intervention, patient's satisfaction from treatment was significantly higher in nose clip group.
T
This study revealed that applying nose clips is a simple, but effective way in
AC
CE
PT
ED
M
AN
US
CR
IP
controlling epistaxis leading to time saving and reducing more invasive treatments.
5
ACCEPTED MANUSCRIPT References 1.
Melia L, McGarry GW. Epistaxis: update on management. Curr Opin Otolaryngol Head Neck Surg 2011;19:30–5.
2.
Kilty, S.J., et al., Prospective clinical trial of gelatin-thrombin matrix as first line treatment of posterior epistaxis. Laryngoscope, 2014. 124(1): p.
Tomkinson A, Roblin DG, Flanagan P, et al. Patterns of hospital
IP
3.
T
38-42.
4.
CR
attendance with epistaxis. Rhinology 1997;35(3):129–31. Viehweg, T.L., J.B. Roberson, and J.W. Hudson, Epistaxis: diagnosis and
Douglas, R. and P.J. Wormald, Update on epistaxis. Curr Opin
AN
5.
US
treatment. J Oral Maxillofac Surg, 2006. 64(3): p. 511-8.
Otolaryngol Head Neck Surg, 2007. 15(3): p. 180-3. Fukutsuji, K., et al., Superselective angiographic embolization for
M
6.
intractable epistaxis. Acta oto-laryngologica, 2008. 128(5): p. 556-560. Viehweg TL, Roberson JB, Hudson JW. Epistaxis: diagnosis and
ED
7.
treatment. J Oral Maxillofac Surg 2006;64(3):511–8. Zahed R, Moharamzadeh P, AlizadehArasi S, Ghasemi A, Saeedi M. A
PT
8.
CE
new and rapid method for epistaxis treatment using injectable form of tranexamic acid topically: a randomized controlled trial. The American
9.
AC
journal of emergency medicine. 2013 Sep 30;31(9):1389-92. Bertrand B, Eloy P, Rombaux P, Lamarque C, Watelet JB, Collet S. Guidelines to the managment of epistaxis. B ENT. 2005 Jan 1:27.
6
ACCEPTED MANUSCRIPT Assessed for eligibility n=91
Excluded from the study, n=26 Due to Trauma, n=13 Anti coagulant usage, n=2 Posterior epistaxis, n=2 Unstable hemodynamic, n=5 Unwillingness, n=2 History of treatment in past 6 month, n=2
Analyzed, n=31
AC
CE
PT
ED
M
Figure 1: Flow diagram
AN
Lost to follow-up, n=0
7
Allocated to nose clip, n=32 Received intervention, n=30
CR
US
Allocated to manual compression, n=33 Received intervention, n=31
IP
T
Randomized n=65
Lost to follow-up, n=0
Analyzed, n=30
ACCEPTED MANUSCRIPT
AC
CE
PT
ED
M
AN
US
CR
IP
T
Table 1 Baseline characteristics of enrolled patients Variables Nose clip Manual Patients N 30 31 Age mean (range) 41 (19-77) 44 (17-68) Male: Female 14:16 16:15 Epistaxis severity before intervention N (%) Spotting 7 (23) 6 (19) Oozing 8 (26) 9 (29) Stream 15 (50) 16 (51)
8
Mehdi Momeni, Elnaz Vahidi, Javad Safavi, Morteza Saeedi PII: DOI: Reference:
S0735-6757(17)30555-7 doi: 10.1016/j.ajem.2017.07.025 YAJEM 56811
To appear in: Received date: Revised date: Accepted date:
18 June 2017 4 July 2017 6 July 2017
Please cite this article as: Mehdi Momeni, Elnaz Vahidi, Javad Safavi, Morteza Saeedi , Procalcitonin and D-dimer in predicting 28-day-mortality rate and severity of sepsis based on SOFA score, (2017), doi: 10.1016/j.ajem.2017.07.025
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. 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.
ACCEPTED MANUSCRIPT Procalcitonin and D-dimer in predicting 28-day-mortality rate and severity of sepsis based on SOFA score Mehdi Momeni , MD ; Assistant Professor of Emergency Medicine, Emergency Medicine Research Center, Shariati Hospital; Emergency Medicine Department, Tehran University of Medical Sciences, Tehran, Iran
IP
T
Elnaz Vahidi, MD ; Assistant Professor of Emergency Medicine, Emergency Medicine Research Center, Shariati Hospital, Emergency Medicine Department, Tehran University of Medical Sciences, Tehran, Iran
US
CR
Javad Safavi, MD ; Emergency Medicine Department, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran
AN
Morteza Saeedi, MD; Associate Professor of Emergency Medicine, Emergency Medicine Research Center, Shariati Hospital; Emergency Medicine Department, Tehran University of Medical Sciences, Tehran, Iran
M
Corresponding author: Morteza Saeedi, MD ; Tehran University of Medical Sceinces, Prehospital Emergency Research Center, Shariati Hospital.
ED
North Amirabad street Tehran Iran Tel: 982184902719; Fax: 982188633039
PT
[email protected]
CE
Short running title: Procalcitonin and D-dimer in predicting mortality rate
AC
We have not funding source Word count: 2744
Trail was registered in www.irct.ir and trail number is IRCT201408068872N5
Author’s contributions: Momeni M; study design and supervision, Safavi J; data gathering and analysis, Vahidi E; data analysis and drafting, Saeedi M; critical revision
1
ACCEPTED MANUSCRIPT Epistaxis is a common complaint in patients presenting to Emergency Department with the annual prevalence of about 11 % [1, 2]. Sixty percent of population experience epistaxis at least once during life [3, 4]. Annually, 14.9 out of 10000 persons need medical care for epistaxis and among these, 1.6 are admitted [5]. Eighty to ninety percent of epistaxis is originated from anterior nasal cavity [6],
T
Direct compression of the cartilaginous part of the nose for 10 – 15 minutes is a
IP
simple and effective way to control epistaxis with success rate up to 65% [7],
CR
however; it is often missed in epistaxis management and the needed time is not
US
considered by the patient [8].
The application of direct pressure with a correct method and enough time can
may prevent their adverse events [9].
AN
easily obviate the need for further aggressive and expensive interventions and it
AC
CE
PT
ED
M
It is supposed that patients do not apply manual compression constantly for enough time, therefore nose clips may have better success rate because they are not in need of patients’ cooperation.
2
ACCEPTED MANUSCRIPT This study is a randomized clinical trial conducted in Shahid Rahnemoon Hospital Emergency Department from January 2016 to July 2016. The study was approved by Ethics Committee of Shahid Sadoughi University of Medical Sciences. Patients triaged with chief complaint of epistaxis were visited by the physicians in
T
charge of the study and eligible patients were selected. All the assistants involved
IP
in the study were trained to glean the required data.
CR
Patients older than 16 years presented to the Emergency Department with active epistaxis of anterior origin were included in the study.
US
Patients were excluded from the study if there were traumatic or post-surgery
AN
epistaxis, bleeding disorders or anticoagulant use, intervention for controlling epistaxis in recent six months, posterior epistaxis, hemodynamic instability, upper
M
respiratory tract infection, association with a significant complaint (e.g. chest pain), and septal deviation.
ED
After written informed consent, patients eligible for the study was randomized into intervention group (nose clips) and control group (manual compression After
PT
allocation, demographic information of the patients was recorded in a prepared
CE
form. Severity of epistaxis was defined as, no bleeding (1), spotting (2), oozing (3) and severe blood flow (4).
AC
After clearing the clots by blowing the nose, patients were asked to sit on a chair and have sniffing position. In intervention group, nose clip by the nurse, and in control group manual compression by the patient were applied to the cartilaginous part of the nose for 15 minutes. Then the compression was relieved and bleeding severity was assessed and recorded. If bleeding did not stop, the next step was cauterization of bleeding site, if visible, or anterior nasal tampon. If these measures were not successful, the next step was 3
ACCEPTED MANUSCRIPT ENT consultation. Finally, patients satisfaction from the treatment was measured via Likert scale (strongly satisfied, satisfied, no idea, dissatisfied, strongly dissatisfied) Length of stay in the emergency department was measured from the admittion and
T
disposition time and recorded.
AN
US
CR
IP
Twenty six of 92 patients were excluded from the study and the remaining 66 were randomly allocated to two groups of 33 patients. Finally, 30 patients in group A (nose clip) and 31 patients in group B (manual compression) were treated and analyzed (figure 1). Age, sex, and epistaxis severity before intervention were the same in both groups (table 1).
M
Both interventions seemed successful in controlling epistaxis (p value: 0.000) and epistaxis was controlled to full stop (50.8) or spotting (19.7) in 70.5 % of patients.
ED
Nose clip was better in controlling epistaxis especially in severe epistaxis (p value: 0.008). ENT consultations were ordered more in manual compression group, but it
PT
was not statistically significant (p value: 0.8). Emergency Department stays in nose
CE
clip group was less than manual compression (p value: 0.000). Satisfaction was higher in nose clip group (p value: 0.000).
AC
As the study interventions were nose clip and manual compression, blinding of the patients was impossible. Nose clip used in this study applies constant bilateral compression to the cartilaginous part of the nose. It had better success rate than manual compression to fully stop the bleeding (66.7 % versus 35.5 %). Only 1 patient (3.3%) had severe blood flow after applying nose clip much less than control (11 patients [35.5%]). It is supposed that this difference in controlling epistaxis is due to dependency of manual compression to patient’s cooperation. 4
ACCEPTED MANUSCRIPT In control group, further invasive and more time consuming treatment methods increased the length of stay in the Emergency Department. It seems that owing to better controlling of epistaxis, shorter length of stay, and less ENT consultation and intervention, patient's satisfaction from treatment was significantly higher in nose clip group.
T
This study revealed that applying nose clips is a simple, but effective way in
AC
CE
PT
ED
M
AN
US
CR
IP
controlling epistaxis leading to time saving and reducing more invasive treatments.
5
ACCEPTED MANUSCRIPT References 1.
Melia L, McGarry GW. Epistaxis: update on management. Curr Opin Otolaryngol Head Neck Surg 2011;19:30–5.
2.
Kilty, S.J., et al., Prospective clinical trial of gelatin-thrombin matrix as first line treatment of posterior epistaxis. Laryngoscope, 2014. 124(1): p.
Tomkinson A, Roblin DG, Flanagan P, et al. Patterns of hospital
IP
3.
T
38-42.
4.
CR
attendance with epistaxis. Rhinology 1997;35(3):129–31. Viehweg, T.L., J.B. Roberson, and J.W. Hudson, Epistaxis: diagnosis and
Douglas, R. and P.J. Wormald, Update on epistaxis. Curr Opin
AN
5.
US
treatment. J Oral Maxillofac Surg, 2006. 64(3): p. 511-8.
Otolaryngol Head Neck Surg, 2007. 15(3): p. 180-3. Fukutsuji, K., et al., Superselective angiographic embolization for
M
6.
intractable epistaxis. Acta oto-laryngologica, 2008. 128(5): p. 556-560. Viehweg TL, Roberson JB, Hudson JW. Epistaxis: diagnosis and
ED
7.
treatment. J Oral Maxillofac Surg 2006;64(3):511–8. Zahed R, Moharamzadeh P, AlizadehArasi S, Ghasemi A, Saeedi M. A
PT
8.
CE
new and rapid method for epistaxis treatment using injectable form of tranexamic acid topically: a randomized controlled trial. The American
9.
AC
journal of emergency medicine. 2013 Sep 30;31(9):1389-92. Bertrand B, Eloy P, Rombaux P, Lamarque C, Watelet JB, Collet S. Guidelines to the managment of epistaxis. B ENT. 2005 Jan 1:27.
6
ACCEPTED MANUSCRIPT Assessed for eligibility n=91
Excluded from the study, n=26 Due to Trauma, n=13 Anti coagulant usage, n=2 Posterior epistaxis, n=2 Unstable hemodynamic, n=5 Unwillingness, n=2 History of treatment in past 6 month, n=2
Analyzed, n=31
AC
CE
PT
ED
M
Figure 1: Flow diagram
AN
Lost to follow-up, n=0
7
Allocated to nose clip, n=32 Received intervention, n=30
CR
US
Allocated to manual compression, n=33 Received intervention, n=31
IP
T
Randomized n=65
Lost to follow-up, n=0
Analyzed, n=30
ACCEPTED MANUSCRIPT
AC
CE
PT
ED
M
AN
US
CR
IP
T
Table 1 Baseline characteristics of enrolled patients Variables Nose clip Manual Patients N 30 31 Age mean (range) 41 (19-77) 44 (17-68) Male: Female 14:16 16:15 Epistaxis severity before intervention N (%) Spotting 7 (23) 6 (19) Oozing 8 (26) 9 (29) Stream 15 (50) 16 (51)
8