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Removal of impacted cerumen in children using an aural irrigation system
International Journal of Pediatric Otorhinolaryngology 76 (2012) 1840–1843
Contents lists available at SciVerse ScienceDirect
International Journal of Pediatric Otorhinolaryngology journal homepage: www.elsevier.com/locate/ijporl
Removal of impacted cerumen in children using an aural irrigation system Evan J. Propst a,*, Tomka George a, Arif Janjua b, Adrian James a, Paolo Campisi a, Vito Forte a a b
Department of Otolaryngology, The Hospital for Sick Children; Department of Otolaryngology - Head & Neck Surgery, University of Toronto, Toronto, Canada Division of Otolaryngology, Vancouver General Hospital, Vancouver, Canada
A R T I C L E I N F O
A B S T R A C T
Article history: Received 23 July 2012 Received in revised form 6 September 2012 Accepted 7 September 2012 Available online 4 October 2012
Objectives: Impacted cerumen in the ear canal is a common problem that can cause discomfort or prevent assessment. Cerumen removal can have deleterious side effects if performed improperly. We created an aural irrigation system which is currently not available on the market to provide a continuous flow of water at a regulated pressure and temperature. The purposes of this study were to (1) evaluate the safety and efficacy of this aural irrigation system in children and (2) determine the success rate of cerumen disimpaction when used by an allied health professional. Methods: The following were evaluated in a nurse-run clinic: (1) referral patterns; (2) extent of canal occlusion; (3) cerumen consistency; (4) peak water pressure used; (5) patient discomfort; (6) efficacy of removal. Each ear was recorded as a separate event. Results: 302 procedures were performed on 244 children (mean age 7.6 4.1 years (range 0.5– 18.3 years)). Patients were most commonly referred by an Otolaryngologist (63%), parent (17%), hearing aid provider (10%) or audiologist (9%). The most common reasons for referral were difficulty seeing the tympanic membrane (42%), fitting a hearing aid (20%) or performing an audiogram (11%). Prior to irrigation, 98% of canals were partially or fully occluded. After irrigation (mean peak pressure = 488.21 18.61 mmHg (range 390–590 mmHg), 92% of canals were completely free of cerumen (99% clear enough for evaluation or treatment). There was mild or no discomfort in 99% of patients and there were no incidences of trauma. Conclusions: An aural irrigation system can be effective at clearing impacted cerumen from pediatric ear canals with minimal discomfort and no trauma and can be successfully employed in a completely nurserun clinic. ß 2012 Elsevier Ireland Ltd. All rights reserved.
Keywords: Cerumen Cerumin Removal Irrigation Debridement Tympanic membrane Rupture Ear canal Water Pressure Safety
1. Introduction Cerumen is a combination of glandular secretions from the outer one-third of the external auditory canal and exfoliated squamous epithelium that normally migrates out of the ear canal by a self-cleaning mechanism assisted by jaw movement [1]. Failure of this self-cleaning mechanism can lead to cerumen impaction, which Roland et al. [2] define in their clinical practice guideline as an accumulation of cerumen that causes symptoms, prevents a needed assessment of the ear canal/tympanic membrane or audiovestibular system, or both. Cerumen impaction is present in approximately 1 in 10 children, 1 in 13 adults, and one third of geriatric and developmentally delayed populations [3–5]. Symptoms of cerumen impaction may include discomfort, hearing loss, balance disorders, tinnitus, infection and inability to fit
* Corresponding author at: Department of Otolaryngology, 6th Floor, Burton Wing, The Hospital for Sick Children, 555 University Avenue, Toronto, Ontario M5G 1X8, Canada. Tel.: +1 416 813 6532; fax: +1 416 813 5036. E-mail address: [email protected] (E.J. Propst). 0165-5876/$ – see front matter ß 2012 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijporl.2012.09.014
hearing aids. It is one of the most common reasons that patients seek ear-related medical care, with approximately eight million cerumen removal procedures performed annually in the United States alone [6]. In an effort to manage cerumen impaction more effectively, efficiently and safely, a clinical practice guideline has recommended that clinicians (1) treat cerumen impaction that is symptomatic or prevents clinical examination when warranted, (2) assess for factors that modify management such as non intact tympanic membrane, ear canal stenosis, exostoses, diabetes, immunocompromised state, or anticoagulant therapy, (3) examine patients with hearing aids, (4) treat with irrigation, cerumenolytics or manual removal, (5) assess patients after treatment and document resolution, (6) prescribe additional treatment if it has not resolved [2]. Multiple methods for removing cerumen exist, including instillation of cerumenolytic agents, manual removal using curettes/hooks/forceps/suction, and irrigation. A systematic review of the safety and effectiveness of different methods of earwax removal found that on measures of wax clearance, water was more effective than no treatment, wet irrigation was better than dry
E.J. Propst et al. / International Journal of Pediatric Otorhinolaryngology 76 (2012) 1840–1843
irrigation (compressed air), and irrigation by a nurse was more effective than self-irrigation [7]. Evidence regarding the effectiveness of irrigation or mechanical removal was equivocal. Aural irrigation is often preferred over manual removal by family physicians, pediatricians and nurses because they do not routinely have access to microscopes and irrigation is easier to perform. Though cerumen removal is usually safe when performed by an experienced professional, it requires a substantial time commitment and complications can occur. A large review of 26 clinical trials on cerumen removal found that 10% of participants experienced a minor adverse event [7]. It is estimated that approximately 8000 complications result from aural irrigation in the United States annually, including ear canal laceration, infection, tympanic membrane perforation, hearing loss, pain, vertigo and syncope [2]. The pressure required to rupture the tympanic membrane seems to vary based on patient age and physical properties of the tympanic membrane. Keller (1958) was the first to systematically investigate rupture pressures of the tympanic membrane. Using a hand-pumped air pressure tank attached to a metal hand piece, he delivered pressurized air to the tympanic membranes of 15 cadaveric specimens and found the mean rupture pressure to be 1.7 atm (range 0.95–2.2 atm; 1293 mmHg, range 724– 1707 mmHg; 1 atm = 760 mmHg). Hedegaard Jensen and Bonding [9] used water to determine the rupture pressure of postmortem tympanic membranes and found that normal tympanic membranes ruptured at pressures of 1.2 atm (range 0.5–2.1 atm; 912 mmHg, range 380–1596 mmHg) while tympanic membranes with atrophic scars ruptured at 0.6 atm (range 0.3–0.8 atm; 456 mmHg, range 228–608 mmHg). The pressure required to rupture the tympanic membrane was found to be highest in younger individuals and decrease with increasing age, confirming findings of tympanic membrane rupture following a bomb explosion in Belfast where perforations were far more common in older victims [10]. Sørensen and Bonding [11] irrigated cadaveric external auditory canals using four different irrigation devices (metal, plastic and glass syringes and a rubber balloon) and found that the highest pressures obtained (using a metal syringe in normal or wide external auditory canals) were insufficient to rupture normal tympanic membranes but sufficient to rupture atrophic tympanic membranes in adults age 50–84 years (mean 0.3 atm, range 0.3–0.4 atm; 240 mmHg, range 200–300 mmHg). Interestingly, this study investigated irrigation of different tympanic membrane quadrants but not the degree of external auditory canal occlusion by the irrigating device; a variable that the authors themselves note could lead to the generation of enormous pressures in the external auditory canal.
1841
Recognizing the inherent risks of aural irrigation, the senior author developed an aural irrigation system to clean cerumen using a continuous flow of water at a regulated pressure and temperature. The purposes of this study were to (1) evaluate the safety and efficacy of this aural irrigation system for cerumen removal in children and (2) determine the success rate of cerumen disimpaction by an allied health professional, rather than an Otolaryngologist – Head and Neck Surgeon. 2. Methods 2.1. Aural irrigation system This aural irrigation system attaches to a standard sink faucet to provide a continuous flow of water (Fig. 1). Water flow is regulated by a standard pressure control valve (adjustable between 0 and 760 mmHg, usually maintained between 300 and 700 mmHg). Water passes through a reservoir with a temperature sensor and through a flexible duct to a hand piece with a nozzle that accepts standard disposable otoscope tips. A flow valve is located on the body of the hand piece and there is an automatic pressure release valve if the external auditory canal pressure exceeds set limits during complete canal occlusion by the device. There is a splashguard on the hand piece to prevent the irrigator and patient from getting wet. The collection device has a suction drain powered by a venturi valve that uses a separate tube to carry water from the faucet to create a low-pressure zone/partial vacuum. Excess water and diluted cerumen then travel from the collection device to the sink basin for disposal. Smaller children were gently supported during the procedure and participation by larger children was exceptionally good. In the rare case that an older patient refused treatment, irrigation was not performed. The duration of irrigation was generally 2–3 min per ear, however, the exact duration was not recorded. The nurse’s instructions were to promptly stop irrigation if a patient complained of discomfort, vertigo or other unusual symptoms. 2.2. Data collection This study evaluated the following in a single nurse-run aural irrigation clinic over an 18-month period: (1) referral patterns for cerumen removal (obtained from referral letters); (2) extent of external auditory canal occlusion by cerumen (none/partial/ complete, assessed via otoscopy by the nurse); (3) cerumen consistency (soft/hard); (4) peak water pressure necessary for clearance of cerumen (from display on machine); (5) level of patient discomfort (determined by the irrigating nurse using a
Fig. 1. The aural irrigation system. (A) Device with connections to faucet and sink. 1. Pressure gauge. 2. Temperature gauge. 3. Handheld irrigating device with splashguard. 4. Collection device with suction powered drain. (B) Study nurse demonstrating how the device is used in a patient.
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E.J. Propst et al. / International Journal of Pediatric Otorhinolaryngology 76 (2012) 1840–1843
Fig. 2. Referral patterns for cerumen removal. Fig. 3. Reason for referral for cerumen removal.
modified ‘‘oucher scale’’ rather than asking the young patient to express it directly [12]); (6) rate of successful cerumen removal. Each ear irrigated was recorded as a separate event. Patients with a history of prior ear surgery, cholesteatoma, ventilation tubes or atelectasis were considered not to be candidates for aural irrigation and were referred to an Otolaryngologist for microdebridement instead. Institutional Research Ethics Board approval was obtained for this study. 3. Results 302 procedures were performed on 244 children (143 male, 101 female) with a mean age of 7.55 4.13 years (range 0.49– 18.25 years). Fig. 2 demonstrates referral patterns for patients with impacted cerumen, with the majority being sent by an Otolaryngologist (63%), parent (17%), hearing aid provider (10%) or audiologist (9%). Very few patients were referred by a pediatrician or family physician. Fig. 3 shows the reason for referral, with the most common being that the tympanic membrane was not visible (42%), or there was difficulty fitting a hearing aid (20%) or performing an audiogram (11%). Most patients had similar cerumen bilaterally. The most common finding was that both ears either had soft cerumen (48.3%) or hard cerumen (42.9%) bilaterally, with a minority having soft cerumen on one side and hard cerumen on the other (8.8%). Only 1.3% of patients had an aural foreign body. Prior to irrigation, 97.6% of canals were partially or fully occluded bilaterally. After irrigation with a mean peak water pressure of 488.21 18.61 mmHg (range 390–590 mmHg; 0.6 atm, range 0.5–0.8 atm), 91.9% of auditory canals were completely free of cerumen (99% of canals displayed improvement in obstruction). Patient discomfort was rated as mild (discomfort 5 out of 10) in 98.9% of patients, with 75.2% of patients having no discomfort at all. There were no incidences of aural trauma using this aural irrigation system. 4. Discussion We developed an aural irrigation system to simplify cerumen removal and minimize complications by providing a continuous flow of water at a regulated pressure and temperature. Over three hundred procedures were performed by nurses on children ranging from 6 months to 18 years of age, suggesting that the system is easy to use even on patients that can at times be uncooperative. Patients were most commonly referred by an Otolaryngologist, parent, hearing aid provider or audiologist, and were much less likely to be referred by a pediatrician or family physician. This may be due to the fact that family physicians and pediatricians can
perform aural irrigation in the office, they can be reimbursed for cerumen irrigation, or that they are not aware of safe and effective aural irrigation devices. Another possibility is that Otolaryngologists, hearing aid providers and audiologists may be more strict about achieving complete removal of cerumen to be able to perform subsequent procedures, whereas pediatricians and family physicians may only need to remove enough cerumen to be able to assess the tympanic membrane or may downplay the issue of cerumen impaction because it is time consuming and difficult to deal with. Within an individual patient, the type and distribution of cerumen was most commonly the same in both external auditory canals. This is likely due to the fact that cerumen production and composition is genetically determined and other factors such as degree of self-debridement and exposure to water and temperature changes are usually consistent across ears [13]. The degree of cerumen occlusion (i.e. effectiveness of irrigation device) improved in 99% of ears after irrigation, with approximately 92% of ear canals being completely free from cerumen. It is important to note that the remaining patients had enough cerumen removed by this procedure to properly evaluate the middle ear, perform audiologic testing, or have their hearing aids fitted as required. The mean peak water pressure used was 488 mmHg (range 390–590 mmHg), and no patient incurred a tympanic membrane perforation. This is consistent with Keller’s finding that tympanic membranes did not rupture below a pressure of 724 mmHg but interestingly, within the range of pressures that Hedegaard Jensen and Bonding found to rupture both normal (380–1596 mmHg) and atrophic (228–608 mmHg) tympanic membranes [8,9]. This discrepancy may be due to the fact that our study investigated children whose tympanic membranes are more resistant to perforation as compared with adults or because postmortem tympanic membranes are not as resistant to perforation as living tissue [10]. There were no other types of aural trauma experienced in any patients in this study. Patient discomfort was minimal using this aural irrigation system, with 75% having no discomfort and 99% having only mild/moderate discomfort. We used a modified ‘‘oucher scale’’ for patients of all ages for consistency. In the original description of the ‘‘oucher scale’’, children 3 years of age and older are asked to point to a photograph that best represents their level of discomfort [12]. In our study, the same experienced nurse carefully observed each patient and correlated his or her facial expression with the expression on the scale. Using this method, we were able to evaluate discomfort for even small children under the age of 3 years. Although we recognize that observation and inference of feelings may not be as accurate as a patient’s
E.J. Propst et al. / International Journal of Pediatric Otorhinolaryngology 76 (2012) 1840–1843
expression of his or her feelings, we felt that it would be beneficial to obtain these recordings even in the youngest children involved in this study. We also remind the reader that the nurse who performed all procedures in this study was an experienced nurse with adequate training and excellent judgment, which may not translate to every reader’s clinical practice. 5. Conclusion By providing a continuous flow of water at a regulated temperature and pressure using an aural irrigation system, we were able to completely clear all cerumen from over 90% of pediatric ear canals with minimal discomfort and no incidences of aural trauma. This system is feasible in a completely nurse-run clinic. Funding None. Conflicts of interest None of the authors have any conflicts of interest to declare.
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References [1] P.W. Alberti, Epithelial migration on the tympanic membrane, J. Laryngol. Otol. 78 (1964) 808–830. [2] P.S. Roland, T.L. Smith, S.R. Schwartz, R.M. Rosenfeld, B. Ballachanda, J.M. Earll, et al., Clinical practice guideline: cerumen impaction, Otolaryngol. Head Neck Surg. 139 (2008) S1–S21. [3] E. Bricco, Impacted cerumen as a reason for failure in hearing conservation programs, J. Sch. Health 55 (1985) 240–241. [4] A.F. Roche, R.M. Siervogel, J.H. Himes, Longitudinal study of hearing in children: baseline data concerning auditory thresholds, noise exposure, and biological factors, J. Acoust. Soc. Am. 64 (1978) 1593–1601. [5] R.J. Roeser, B.B. Ballachanda, Physiology, pathophysiology, and anthropology/epidemiology of human earcanal secretions, J. Am. Acad. Audiol. 8 (1997) 391–400. [6] M. Grossan, Cerumen removal – current challenges, Ear Nose Throat J. 77 (1998) 541–548. [7] A.J. Clegg, E. Loveman, E. Gospodarevskaya, P. Harris, A. Bird, J. Bryant, et al., The safety and effectiveness of different methods of earwax removal: a systematic review and economic evaluation, Health Technol. Assess. 14 (2010) 1–192. [8] A.P. Keller Jr., A study of the relationship of air pressure to myringorupture, Laryngoscope 68 (1958) 2015–2029. [9] J. Hedegaard Jensen, P. Bonding, Experimental pressure induced rupture of the tympanic membrane in man, Acta Otolaryngol. 113 (1993) 62–67. [10] A.G. Kerr, J.E.T. Byrne IV, Blast injuries of the ear, Br. Med. J. 1 (1975) 559–561. [11] V.Z. Sørensen, P. Bonding, Can ear irrigation cause rupture of the normal tympanic membrane? An experimental study in man, J. Laryngol. Otol. 109 (1995) 1036–1040. [12] J.E. Beyer, The Oucher: A User’s Manual and Technical Report, University of Virginia Alumni Patent Foundation, Charlottesville, 1984. [13] Y. Shugyo, N. Sudo, K. Kanai, T. Yamashita, T. Kumazawa, S. Kanamura, Morphological differences between secretory cells of wet and dry types of human ceruminous glands, Am. J. Anat. 181 (1988) 377–384.
Contents lists available at SciVerse ScienceDirect
International Journal of Pediatric Otorhinolaryngology journal homepage: www.elsevier.com/locate/ijporl
Removal of impacted cerumen in children using an aural irrigation system Evan J. Propst a,*, Tomka George a, Arif Janjua b, Adrian James a, Paolo Campisi a, Vito Forte a a b
Department of Otolaryngology, The Hospital for Sick Children; Department of Otolaryngology - Head & Neck Surgery, University of Toronto, Toronto, Canada Division of Otolaryngology, Vancouver General Hospital, Vancouver, Canada
A R T I C L E I N F O
A B S T R A C T
Article history: Received 23 July 2012 Received in revised form 6 September 2012 Accepted 7 September 2012 Available online 4 October 2012
Objectives: Impacted cerumen in the ear canal is a common problem that can cause discomfort or prevent assessment. Cerumen removal can have deleterious side effects if performed improperly. We created an aural irrigation system which is currently not available on the market to provide a continuous flow of water at a regulated pressure and temperature. The purposes of this study were to (1) evaluate the safety and efficacy of this aural irrigation system in children and (2) determine the success rate of cerumen disimpaction when used by an allied health professional. Methods: The following were evaluated in a nurse-run clinic: (1) referral patterns; (2) extent of canal occlusion; (3) cerumen consistency; (4) peak water pressure used; (5) patient discomfort; (6) efficacy of removal. Each ear was recorded as a separate event. Results: 302 procedures were performed on 244 children (mean age 7.6 4.1 years (range 0.5– 18.3 years)). Patients were most commonly referred by an Otolaryngologist (63%), parent (17%), hearing aid provider (10%) or audiologist (9%). The most common reasons for referral were difficulty seeing the tympanic membrane (42%), fitting a hearing aid (20%) or performing an audiogram (11%). Prior to irrigation, 98% of canals were partially or fully occluded. After irrigation (mean peak pressure = 488.21 18.61 mmHg (range 390–590 mmHg), 92% of canals were completely free of cerumen (99% clear enough for evaluation or treatment). There was mild or no discomfort in 99% of patients and there were no incidences of trauma. Conclusions: An aural irrigation system can be effective at clearing impacted cerumen from pediatric ear canals with minimal discomfort and no trauma and can be successfully employed in a completely nurserun clinic. ß 2012 Elsevier Ireland Ltd. All rights reserved.
Keywords: Cerumen Cerumin Removal Irrigation Debridement Tympanic membrane Rupture Ear canal Water Pressure Safety
1. Introduction Cerumen is a combination of glandular secretions from the outer one-third of the external auditory canal and exfoliated squamous epithelium that normally migrates out of the ear canal by a self-cleaning mechanism assisted by jaw movement [1]. Failure of this self-cleaning mechanism can lead to cerumen impaction, which Roland et al. [2] define in their clinical practice guideline as an accumulation of cerumen that causes symptoms, prevents a needed assessment of the ear canal/tympanic membrane or audiovestibular system, or both. Cerumen impaction is present in approximately 1 in 10 children, 1 in 13 adults, and one third of geriatric and developmentally delayed populations [3–5]. Symptoms of cerumen impaction may include discomfort, hearing loss, balance disorders, tinnitus, infection and inability to fit
* Corresponding author at: Department of Otolaryngology, 6th Floor, Burton Wing, The Hospital for Sick Children, 555 University Avenue, Toronto, Ontario M5G 1X8, Canada. Tel.: +1 416 813 6532; fax: +1 416 813 5036. E-mail address: [email protected] (E.J. Propst). 0165-5876/$ – see front matter ß 2012 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijporl.2012.09.014
hearing aids. It is one of the most common reasons that patients seek ear-related medical care, with approximately eight million cerumen removal procedures performed annually in the United States alone [6]. In an effort to manage cerumen impaction more effectively, efficiently and safely, a clinical practice guideline has recommended that clinicians (1) treat cerumen impaction that is symptomatic or prevents clinical examination when warranted, (2) assess for factors that modify management such as non intact tympanic membrane, ear canal stenosis, exostoses, diabetes, immunocompromised state, or anticoagulant therapy, (3) examine patients with hearing aids, (4) treat with irrigation, cerumenolytics or manual removal, (5) assess patients after treatment and document resolution, (6) prescribe additional treatment if it has not resolved [2]. Multiple methods for removing cerumen exist, including instillation of cerumenolytic agents, manual removal using curettes/hooks/forceps/suction, and irrigation. A systematic review of the safety and effectiveness of different methods of earwax removal found that on measures of wax clearance, water was more effective than no treatment, wet irrigation was better than dry
E.J. Propst et al. / International Journal of Pediatric Otorhinolaryngology 76 (2012) 1840–1843
irrigation (compressed air), and irrigation by a nurse was more effective than self-irrigation [7]. Evidence regarding the effectiveness of irrigation or mechanical removal was equivocal. Aural irrigation is often preferred over manual removal by family physicians, pediatricians and nurses because they do not routinely have access to microscopes and irrigation is easier to perform. Though cerumen removal is usually safe when performed by an experienced professional, it requires a substantial time commitment and complications can occur. A large review of 26 clinical trials on cerumen removal found that 10% of participants experienced a minor adverse event [7]. It is estimated that approximately 8000 complications result from aural irrigation in the United States annually, including ear canal laceration, infection, tympanic membrane perforation, hearing loss, pain, vertigo and syncope [2]. The pressure required to rupture the tympanic membrane seems to vary based on patient age and physical properties of the tympanic membrane. Keller (1958) was the first to systematically investigate rupture pressures of the tympanic membrane. Using a hand-pumped air pressure tank attached to a metal hand piece, he delivered pressurized air to the tympanic membranes of 15 cadaveric specimens and found the mean rupture pressure to be 1.7 atm (range 0.95–2.2 atm; 1293 mmHg, range 724– 1707 mmHg; 1 atm = 760 mmHg). Hedegaard Jensen and Bonding [9] used water to determine the rupture pressure of postmortem tympanic membranes and found that normal tympanic membranes ruptured at pressures of 1.2 atm (range 0.5–2.1 atm; 912 mmHg, range 380–1596 mmHg) while tympanic membranes with atrophic scars ruptured at 0.6 atm (range 0.3–0.8 atm; 456 mmHg, range 228–608 mmHg). The pressure required to rupture the tympanic membrane was found to be highest in younger individuals and decrease with increasing age, confirming findings of tympanic membrane rupture following a bomb explosion in Belfast where perforations were far more common in older victims [10]. Sørensen and Bonding [11] irrigated cadaveric external auditory canals using four different irrigation devices (metal, plastic and glass syringes and a rubber balloon) and found that the highest pressures obtained (using a metal syringe in normal or wide external auditory canals) were insufficient to rupture normal tympanic membranes but sufficient to rupture atrophic tympanic membranes in adults age 50–84 years (mean 0.3 atm, range 0.3–0.4 atm; 240 mmHg, range 200–300 mmHg). Interestingly, this study investigated irrigation of different tympanic membrane quadrants but not the degree of external auditory canal occlusion by the irrigating device; a variable that the authors themselves note could lead to the generation of enormous pressures in the external auditory canal.
1841
Recognizing the inherent risks of aural irrigation, the senior author developed an aural irrigation system to clean cerumen using a continuous flow of water at a regulated pressure and temperature. The purposes of this study were to (1) evaluate the safety and efficacy of this aural irrigation system for cerumen removal in children and (2) determine the success rate of cerumen disimpaction by an allied health professional, rather than an Otolaryngologist – Head and Neck Surgeon. 2. Methods 2.1. Aural irrigation system This aural irrigation system attaches to a standard sink faucet to provide a continuous flow of water (Fig. 1). Water flow is regulated by a standard pressure control valve (adjustable between 0 and 760 mmHg, usually maintained between 300 and 700 mmHg). Water passes through a reservoir with a temperature sensor and through a flexible duct to a hand piece with a nozzle that accepts standard disposable otoscope tips. A flow valve is located on the body of the hand piece and there is an automatic pressure release valve if the external auditory canal pressure exceeds set limits during complete canal occlusion by the device. There is a splashguard on the hand piece to prevent the irrigator and patient from getting wet. The collection device has a suction drain powered by a venturi valve that uses a separate tube to carry water from the faucet to create a low-pressure zone/partial vacuum. Excess water and diluted cerumen then travel from the collection device to the sink basin for disposal. Smaller children were gently supported during the procedure and participation by larger children was exceptionally good. In the rare case that an older patient refused treatment, irrigation was not performed. The duration of irrigation was generally 2–3 min per ear, however, the exact duration was not recorded. The nurse’s instructions were to promptly stop irrigation if a patient complained of discomfort, vertigo or other unusual symptoms. 2.2. Data collection This study evaluated the following in a single nurse-run aural irrigation clinic over an 18-month period: (1) referral patterns for cerumen removal (obtained from referral letters); (2) extent of external auditory canal occlusion by cerumen (none/partial/ complete, assessed via otoscopy by the nurse); (3) cerumen consistency (soft/hard); (4) peak water pressure necessary for clearance of cerumen (from display on machine); (5) level of patient discomfort (determined by the irrigating nurse using a
Fig. 1. The aural irrigation system. (A) Device with connections to faucet and sink. 1. Pressure gauge. 2. Temperature gauge. 3. Handheld irrigating device with splashguard. 4. Collection device with suction powered drain. (B) Study nurse demonstrating how the device is used in a patient.
1842
E.J. Propst et al. / International Journal of Pediatric Otorhinolaryngology 76 (2012) 1840–1843
Fig. 2. Referral patterns for cerumen removal. Fig. 3. Reason for referral for cerumen removal.
modified ‘‘oucher scale’’ rather than asking the young patient to express it directly [12]); (6) rate of successful cerumen removal. Each ear irrigated was recorded as a separate event. Patients with a history of prior ear surgery, cholesteatoma, ventilation tubes or atelectasis were considered not to be candidates for aural irrigation and were referred to an Otolaryngologist for microdebridement instead. Institutional Research Ethics Board approval was obtained for this study. 3. Results 302 procedures were performed on 244 children (143 male, 101 female) with a mean age of 7.55 4.13 years (range 0.49– 18.25 years). Fig. 2 demonstrates referral patterns for patients with impacted cerumen, with the majority being sent by an Otolaryngologist (63%), parent (17%), hearing aid provider (10%) or audiologist (9%). Very few patients were referred by a pediatrician or family physician. Fig. 3 shows the reason for referral, with the most common being that the tympanic membrane was not visible (42%), or there was difficulty fitting a hearing aid (20%) or performing an audiogram (11%). Most patients had similar cerumen bilaterally. The most common finding was that both ears either had soft cerumen (48.3%) or hard cerumen (42.9%) bilaterally, with a minority having soft cerumen on one side and hard cerumen on the other (8.8%). Only 1.3% of patients had an aural foreign body. Prior to irrigation, 97.6% of canals were partially or fully occluded bilaterally. After irrigation with a mean peak water pressure of 488.21 18.61 mmHg (range 390–590 mmHg; 0.6 atm, range 0.5–0.8 atm), 91.9% of auditory canals were completely free of cerumen (99% of canals displayed improvement in obstruction). Patient discomfort was rated as mild (discomfort 5 out of 10) in 98.9% of patients, with 75.2% of patients having no discomfort at all. There were no incidences of aural trauma using this aural irrigation system. 4. Discussion We developed an aural irrigation system to simplify cerumen removal and minimize complications by providing a continuous flow of water at a regulated pressure and temperature. Over three hundred procedures were performed by nurses on children ranging from 6 months to 18 years of age, suggesting that the system is easy to use even on patients that can at times be uncooperative. Patients were most commonly referred by an Otolaryngologist, parent, hearing aid provider or audiologist, and were much less likely to be referred by a pediatrician or family physician. This may be due to the fact that family physicians and pediatricians can
perform aural irrigation in the office, they can be reimbursed for cerumen irrigation, or that they are not aware of safe and effective aural irrigation devices. Another possibility is that Otolaryngologists, hearing aid providers and audiologists may be more strict about achieving complete removal of cerumen to be able to perform subsequent procedures, whereas pediatricians and family physicians may only need to remove enough cerumen to be able to assess the tympanic membrane or may downplay the issue of cerumen impaction because it is time consuming and difficult to deal with. Within an individual patient, the type and distribution of cerumen was most commonly the same in both external auditory canals. This is likely due to the fact that cerumen production and composition is genetically determined and other factors such as degree of self-debridement and exposure to water and temperature changes are usually consistent across ears [13]. The degree of cerumen occlusion (i.e. effectiveness of irrigation device) improved in 99% of ears after irrigation, with approximately 92% of ear canals being completely free from cerumen. It is important to note that the remaining patients had enough cerumen removed by this procedure to properly evaluate the middle ear, perform audiologic testing, or have their hearing aids fitted as required. The mean peak water pressure used was 488 mmHg (range 390–590 mmHg), and no patient incurred a tympanic membrane perforation. This is consistent with Keller’s finding that tympanic membranes did not rupture below a pressure of 724 mmHg but interestingly, within the range of pressures that Hedegaard Jensen and Bonding found to rupture both normal (380–1596 mmHg) and atrophic (228–608 mmHg) tympanic membranes [8,9]. This discrepancy may be due to the fact that our study investigated children whose tympanic membranes are more resistant to perforation as compared with adults or because postmortem tympanic membranes are not as resistant to perforation as living tissue [10]. There were no other types of aural trauma experienced in any patients in this study. Patient discomfort was minimal using this aural irrigation system, with 75% having no discomfort and 99% having only mild/moderate discomfort. We used a modified ‘‘oucher scale’’ for patients of all ages for consistency. In the original description of the ‘‘oucher scale’’, children 3 years of age and older are asked to point to a photograph that best represents their level of discomfort [12]. In our study, the same experienced nurse carefully observed each patient and correlated his or her facial expression with the expression on the scale. Using this method, we were able to evaluate discomfort for even small children under the age of 3 years. Although we recognize that observation and inference of feelings may not be as accurate as a patient’s
E.J. Propst et al. / International Journal of Pediatric Otorhinolaryngology 76 (2012) 1840–1843
expression of his or her feelings, we felt that it would be beneficial to obtain these recordings even in the youngest children involved in this study. We also remind the reader that the nurse who performed all procedures in this study was an experienced nurse with adequate training and excellent judgment, which may not translate to every reader’s clinical practice. 5. Conclusion By providing a continuous flow of water at a regulated temperature and pressure using an aural irrigation system, we were able to completely clear all cerumen from over 90% of pediatric ear canals with minimal discomfort and no incidences of aural trauma. This system is feasible in a completely nurse-run clinic. Funding None. Conflicts of interest None of the authors have any conflicts of interest to declare.
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