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COMIC
Sponsor study identifier
interventional
100
3 countries
3
Study Start
July 5, 2018
Actual (reported)Primary Completion
May 1, 2019
Actual (reported)Study Completion
July 1, 2019
Actual (reported)Introduction: Endotracheal intubation and mechanical ventilation are lifesaving interventions that are commonly done in the intensive care unit (ICU). The act of intubating someone can cause laryngeal edema (LE) that, if extensive enough, can cause airway obstruction after a patient is extubated. To date, the only test that is available to predict this complication is the cuff leak test (CLT). However, its diagnostic accuracy is uncertain as there have been no randomized controlled trials (RCT) examining this. The Cuff leak and airway Obstruction in Mechanically ventilated ICU patients (COMIC) Randomized Control Trial will be done to examine the impact of CLT on postextubation stridor and reintubation. Subsequently, describing the diagnostic accuracy of this test. Methods: This will be a multi-center centered, pragmatic, double blinded RCT. Mechanically ventilated patients in the ICU, who are deemed ready to be extubated will be included. All patients will have a CLT done prior to extubation. The results of the CLT in the intervention arm will be communicated to the treating physician, and decision to extubate will be left to the treating team, while the results of the CLT for patients in the control arm will not be communicated to the treating physician, and the patient will be extubated, regardless of the result of the CLT. Objective: This is a pilot trial to assess feasibility of conducting a powered RCT. Feasibility outcomes include: consent rate, recruitment rate, and protocol adherence. Clinical outcomes will include postextubation stridor, reintubation, emergency surgical airway, ICU mortality, in hospital mortality, duration of mechanical ventilation, and ICU length of stay in days.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 1, 2017
Actual (reported)December 14, 2017
Actual (reported)July 5, 2018
Actual (reported)May 1, 2019
Actual (reported)July 1, 2019
Actual (reported)Consent Rate
A successful consent rate will be defined as 70% of substitute decision makers (SDMs) or patients approached to consent, choosing to participate in the trial. This will be calculated as the overall proportion of SDMs or patients consenting out of those approached (with 95% CI). Note that a mixed consent model will be obtained. In Canada and Saudi Arabia, a priori or deferred consent model will be used. In Poland, a waved consent model will be used.
1 year
Recruitment Rate
A successful recruitment rate will be defined as achieving enrollment of 40 patients, conventionally expressed as four patients per month over the duration of the trial. While the pilot trial is ongoing, recruitment will be reviewed weekly and the screening records will be reviewed monthly with the cases of missed eligible patients reviewed. If applicable, barriers to enrollment will be addressed to maximize recruitment. The recruitment metric will be measured and interpreted at the end of the pilot trial by calculating the mean number of recruited patients per active screening month.
1 year
Protocol Adherence
Successful adherence will be defined as ≥80%. The adherence will be calculated as the proportion of patients that were assigned to the control arm being extubated after CLT being performed and the portion of people that assigned to the intervention arm who are given the prescribed steroids for a failed CLT. As this pilot trial is ongoing, investigators will review adherence monthly and investigate the reasons for compliance failure. All reasons for either failure to extubate after a failed CLT in the control arm will be investigated. The RC will review the Respiratory Therapists' notes, and the medication profile to determine actual compliance. All reasons for non-compliance will be recorded for both groups using distinguishing clinical reasons (eg. Palliation, death, consent withdrawal, errors).
1 year
Postextubation stridor
48 hours after original extubation
Clinically significant postextubation stridor
48 hours after original extubation
Reintubation
72 hours after original extubation
Emergency surgical airway
30 days
In ICU mortality
1 year
Patients randomized to the intervention arm will have the results of the Cuff Leak Test (CLT) (whether failed or passed) communicated to the treating physician; the treating physician will decide whether to proceed with extubation or not based on the CLT results. It is at the discretion of the treating physician to provide corticosteroids (4-5 mg of intravenous dexamethasone every six hours for up to 24 hours, with the last dose given one hour preceding extubation) and/or delay extubation by 24 hours should the patient fail the CLT.
In the control arm of this trial; the treating physicians and healthcare workers will be blinded to the results of the Cuff Leak Test (CLT); therefore, the Respiratory Therapist (RT) will proceed with extubation without delay or administering systemic steroid, regardless to the CLT results.
The Respiratory Therapist (RT) will perform the CLT on all enrolled patients. The patients will first be switched to volume assist-control (V-AC) with a respiratory rate of 10 breaths/min (to allow patient assist), constant flow of 60 l/min, and tidal volume set to match the average tidal volume currently being delivered during supportive ventilation. The RT will document the average exhaled volume over 3-5 breaths after switching to V-AC. The test will be performed by deflating the ETT balloon cuff with a 10 cc syringe, and: a) auscultation with a stethoscope to identify audible air leak around the ETT, and b) measuring the difference between the average exhaled volume prior to cuff deflation and the average exhaled volume over 3-5 breaths after cuff deflation.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
St Joseph's Hospital
Hamilton, Ontartio, L8N 46, Canada
Jagiellonian University Medical College
Krakow, Lesser Poland Voivodeship, 31-066, Poland
Imam Adbulrahman Bin Faisal University
Dammam, Eastern Province, 34212, Saudi Arabia
Maury E, Guglielminotti J, Alzieu M, Qureshi T, Guidet B, Offenstadt G. How to identify patients with no risk for postextubation stridor? J Crit Care. 2004 Mar;19(1):23-8. doi: 10.1016/j.jcrc.2004.02.005.
Tadie JM, Behm E, Lecuyer L, Benhmamed R, Hans S, Brasnu D, Diehl JL, Fagon JY, Guerot E. Post-intubation laryngeal injuries and extubation failure: a fiberoptic endoscopic study. Intensive Care Med. 2010 Jun;36(6):991-8. doi: 10.1007/s00134-010-1847-z. Epub 2010 Mar 18.
Kimberley A Lewis, MD
McMaster University
Waleed Alhazzani, MD
McMaster University
100 participants (actual enrollment reported by the registry).
First Submitted
December 1, 2017
First Posted
December 14, 2017
Study Start
July 5, 2018
Actual (reported)Contact the study team to confirm eligibility.
Sutherasan Y, Theerawit P, Hongphanut T, Kiatboonsri C, Kiatboonsri S. Predicting laryngeal edema in intubated patients by portable intensive care unit ultrasound. J Crit Care. 2013 Oct;28(5):675-80. doi: 10.1016/j.jcrc.2013.05.011. Epub 2013 Jun 24.
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Demling RH, Read T, Lind LJ, Flanagan HL. Incidence and morbidity of extubation failure in surgical intensive care patients. Crit Care Med. 1988 Jun;16(6):573-7. doi: 10.1097/00003246-198806000-00001.
Esteban A, Alia I, Gordo F, Fernandez R, Solsona JF, Vallverdu I, Macias S, Allegue JM, Blanco J, Carriedo D, Leon M, de la Cal MA, Taboada F, Gonzalez de Velasco J, Palazon E, Carrizosa F, Tomas R, Suarez J, Goldwasser RS. Extubation outcome after spontaneous breathing trials with T-tube or pressure support ventilation. The Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):459-65. doi: 10.1164/ajrccm.156.2.9610109.
Frutos-Vivar F, Esteban A, Apezteguia C, Gonzalez M, Arabi Y, Restrepo MI, Gordo F, Santos C, Alhashemi JA, Perez F, Penuelas O, Anzueto A. Outcome of reintubated patients after scheduled extubation. J Crit Care. 2011 Oct;26(5):502-509. doi: 10.1016/j.jcrc.2010.12.015. Epub 2011 Mar 3.
Torres A, Gatell JM, Aznar E, el-Ebiary M, Puig de la Bellacasa J, Gonzalez J, Ferrer M, Rodriguez-Roisin R. Re-intubation increases the risk of nosocomial pneumonia in patients needing mechanical ventilation. Am J Respir Crit Care Med. 1995 Jul;152(1):137-41. doi: 10.1164/ajrccm.152.1.7599812.
Seymour CW, Martinez A, Christie JD, Fuchs BD. The outcome of extubation failure in a community hospital intensive care unit: a cohort study. Crit Care. 2004 Oct;8(5):R322-7. doi: 10.1186/cc2913. Epub 2004 Jul 20.
Potgieter PD, Hammond JM. "Cuff" test for safe extubation following laryngeal edema. Crit Care Med. 1988 Aug;16(8):818. doi: 10.1097/00003246-198808000-00020. No abstract available.
Ochoa ME, Marin Mdel C, Frutos-Vivar F, Gordo F, Latour-Perez J, Calvo E, Esteban A. Cuff-leak test for the diagnosis of upper airway obstruction in adults: a systematic review and meta-analysis. Intensive Care Med. 2009 Jul;35(7):1171-9. doi: 10.1007/s00134-009-1501-9. Epub 2009 Apr 28.
Kuriyama A, Umakoshi N, Sun R. Prophylactic Corticosteroids for Prevention of Postextubation Stridor and Reintubation in Adults: A Systematic Review and Meta-analysis. Chest. 2017 May;151(5):1002-1010. doi: 10.1016/j.chest.2017.02.017. Epub 2017 Feb 21.
Girard TD, Alhazzani W, Kress JP, Ouellette DR, Schmidt GA, Truwit JD, Burns SM, Epstein SK, Esteban A, Fan E, Ferrer M, Fraser GL, Gong MN, Hough CL, Mehta S, Nanchal R, Patel S, Pawlik AJ, Schweickert WD, Sessler CN, Strom T, Wilson KC, Morris PE; ATS/CHEST Ad Hoc Committee on Liberation from Mechanical Ventilation in Adults. An Official American Thoracic Society/American College of Chest Physicians Clinical Practice Guideline: Liberation from Mechanical Ventilation in Critically Ill Adults. Rehabilitation Protocols, Ventilator Liberation Protocols, and Cuff Leak Tests. Am J Respir Crit Care Med. 2017 Jan 1;195(1):120-133. doi: 10.1164/rccm.201610-2075ST.
Altinok T, Can A. Management of tracheobronchial injuries. Eurasian J Med. 2014 Oct;46(3):209-15. doi: 10.5152/eajm.2014.42. Epub 2014 Aug 26.
Law JA, Broemling N, Cooper RM, Drolet P, Duggan LV, Griesdale DE, Hung OR, Jones PM, Kovacs G, Massey S, Morris IR, Mullen T, Murphy MF, Preston R, Naik VN, Scott J, Stacey S, Turkstra TP, Wong DT; Canadian Airway Focus Group. The difficult airway with recommendations for management--part 1--difficult tracheal intubation encountered in an unconscious/induced patient. Can J Anaesth. 2013 Nov;60(11):1089-118. doi: 10.1007/s12630-013-0019-3. Epub 2013 Oct 17.
Smith OM, McDonald E, Zytaruk N, Foster D, Matte A, Clarke F, Fleury S, Krause K, McArdle T, Skrobik Y, Cook DJ. Enhancing the informed consent process for critical care research: strategies from a thromboprophylaxis trial. Intensive Crit Care Nurs. 2013 Dec;29(6):300-9. doi: 10.1016/j.iccn.2013.04.006. Epub 2013 Jul 18.
Alhazzani W, Guyatt G, Alshahrani M, Deane AM, Marshall JC, Hall R, Muscedere J, English SW, Lauzier F, Thabane L, Arabi YM, Karachi T, Rochwerg B, Finfer S, Daneman N, Alshamsi F, Zytaruk N, Heel-Ansdell D, Cook D; Canadian Critical Care Trials Group. Withholding Pantoprazole for Stress Ulcer Prophylaxis in Critically Ill Patients: A Pilot Randomized Clinical Trial and Meta-Analysis. Crit Care Med. 2017 Jul;45(7):1121-1129. doi: 10.1097/CCM.0000000000002461.
Ouellette DR, Patel S, Girard TD, Morris PE, Schmidt GA, Truwit JD, Alhazzani W, Burns SM, Epstein SK, Esteban A, Fan E, Ferrer M, Fraser GL, Gong MN, Hough CL, Mehta S, Nanchal R, Pawlik AJ, Schweickert WD, Sessler CN, Strom T, Kress JP. Liberation From Mechanical Ventilation in Critically Ill Adults: An Official American College of Chest Physicians/American Thoracic Society Clinical Practice Guideline: Inspiratory Pressure Augmentation During Spontaneous Breathing Trials, Protocols Minimizing Sedation, and Noninvasive Ventilation Immediately After Extubation. Chest. 2017 Jan;151(1):166-180. doi: 10.1016/j.chest.2016.10.036. Epub 2016 Nov 3.
Lewis K, Culgin S, Jaeschke R, Perri D, Marchildon C, Hassall K, Almubarak Y, Szczeklik W, Piraino T, Thabane L, Alqahtani KM, Alghamdi A, Alshahrani M, Alhazzani W. Cuff Leak Test and Airway Obstruction in Mechanically Ventilated Intensive Care Unit Patients: A Pilot Randomized Controlled Clinical Trial. Ann Am Thorac Soc. 2022 Feb;19(2):238-244. doi: 10.1513/AnnalsATS.202103-390OC.
Lewis K, Culgin S, Jaeschke R, Perri D, Marchildon C, Hassall K, Piraino T, Thabane L, Almubarak Y, Alshahrani MS, Rochwerg B, Baw B, Szczeklik W, Karachi T, Alhazzani W; GUIDE Group. Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients (COMIC): a pilot randomised controlled trial protocol. BMJ Open. 2019 Jul 19;9(7):e029394. doi: 10.1136/bmjopen-2019-029394.
Primary Completion
May 1, 2019
Actual (reported)Study Completion
July 1, 2019
Actual (reported)Last Updated
August 26, 2022
Record last verified: 2022-08
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Source: ClinicalTrials.gov.
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