CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 100 enrolled
Drug / intervention
Dexamethasone 4mg +1 moredrug
Likely dose
Dexamethasone 4mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05456542
NCT05456542Phase 3Completed
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Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients (COSMIC): A Pilot Randomized Controlled Trial

St. Joseph's Healthcare Hamilton·interventional·Posted Jul 13, 2022·Updated Mar 10, 2025

In Brief

A Phase 3 clinical trial evaluating Cuff Leak Test and Dexamethasone 4mg for Respiratory Failure. Completed, enrolled 100 participants across 5 sites in 3 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Failure
CountriesCanada, Kuwait, United States
CollaboratorsHamilton Academic Health Sciences Organization

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedJul 13, 2022
Enrollment StartApr 5, 2023
Primary CompletionJan 6, 2025
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 4.0 years ago

Interventions

Cuff Leak Testother

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.

Dexamethasone 4mgdrug

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