COMIC Pilot Trial Summary
Introduction: Endotracheal intubation and mechanical ventilation are lifesaving interventions that are commonly done in the intensive care unit (ICU). Endotracheal intubation can cause laryngeal edema that, if extensive enough, may result in 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. Herein, we present the Cuff leak and airway Obstruction in Mechanically ventilated ICU patients (COMIC) Pilot Trial to determine the feasibility of conducting a definitive RCT that examines the impact of CLT on post-extubation stridor and re-intubation. Subsequently, describing the diagnostic accuracy of this test.
Methods: This will be a multi-centered, pragmatic, double blinded RCT. We will enrol adult mechanically ventilated patients in the ICU, who are deemed ready to be extubated by the treating physician. Patients who are at a high risk for laryngeal edema will be excluded (i.e. larynx fracture, smoke inhalation, preexisting tracheolaryngeal abnormalities, difficult or traumatic intubation, previously failed extubation attempt within the current ICU stay, airway edema, history of postextubation airway obstruction, and pregnant patients). All randomized patients will undergo a CLT prior to extubation. The results of the CLT in the intervention arm will be communicated to the treating physician, and decision to extubate or not 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: Although we will examine all clinical outcomes relevant for the future COMIC RCT, the primary outcomes of the COMIC Pilot Trial will be feasibility outcomes including: consent rate, recruitment rate, and protocol adherence. Clinical outcomes include postextubation stridor, reintubation, emergency surgical airway, ICU mortality, in hospital mortality, duration of mechanical ventilation, and ICU length of stay in days.
ClinicalTrials.gov Identifier: NCT03372707