NCT05456542

Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients

Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients (COSMIC): A Pilot Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: St. Joseph's Healthcare Hamilton · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The COSMIC trial will be a multicentred, national, parallel-group, pragmatic vanguard pilot trial.

Detailed description

The COSMIC trial will be a multicentred, national, parallel-group, pragmatic vanguard pilot trial in adults (≥18 years) who are mechanically ventilated in the ICU with risk factors for LE and an order to extubate has been provided by the treating physician. The aims of this study are to assess: 1. Protocol adherence 2. Recruitment rates 3. Secondary clinical outcomes will be collected, and if feasibility criteria are met, ultimately used in the powered trial pending no major protocol adjustments (otherwise will be reported as cohort data).

Conditions

• Respiratory Failure

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cuff Leak Test	Clinicians perform the cuff leak test (CLT) to help optimize extubation. The test requires deflation of the cuff at the end of the endotracheal tube (ETT) and auscultation for air passing around the ETT. If air movement is not audible on auscultation (a failed CLT) there is a potential presence of laryngeal edema (LE) that may cause post-extubation airway obstruction.
DRUG	Dexamethasone 4mg	Dexamethasone, will be administered to those patients who fail the CLT in the intervention arm (4mg intravenous every 6 hours for 12-24 hours). Dexamethasone belongs to a class of drugs known as corticosteroids

Timeline

• Start date: 2023-04-05
• Primary completion: 2025-01-06
• Completion: 2025-01-06
• First posted: 2022-07-13
• Last updated: 2025-03-10

Locations

5 sites across 3 countries: United States, Canada, Kuwait