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Dexamethasone + Cuff Leak Test for Airway Blockage in Mechanically Ventilated ICU Patients (COSMIC Trial)

Phase 3

Recruiting

Led By Kimberley Lewis, MD

Research Sponsored by St. Joseph's Healthcare Hamilton

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Mechanically ventilated in the ICU with an order to extubate provided by the treating physician

≥18 yrs. of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

COSMIC Trial Summary

This trial will test a new way to give chemotherapy to people with mesothelioma.

Who is the study for?

Adults over 18 in the ICU on a ventilator with plans to remove it can join. They must have been intubated for more than 5 days or meet other risk factors for throat swelling after extubation. Pregnant women, those with neck injuries, recent surgeries, or severe airway edema are excluded.Check my eligibility

What is being tested?

The COSMIC trial is testing if Dexamethasone and a Cuff Leak Test before taking out a breathing tube can predict and prevent throat blockage in ICU patients. It's conducted across multiple centers and randomly assigns patients to different groups.See study design

What are the potential side effects?

Dexamethasone may cause mood changes, increased blood sugar levels, stomach irritation, insomnia, and higher infection risk. The Cuff Leak Test generally has minimal side effects but might include discomfort or cough.

COSMIC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am on a breathing machine in the ICU, but my doctor has ordered it to be removed.

Select...

I am 18 years old or older.

COSMIC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Protocol Adherence

Recruitment Rate

Secondary outcome measures

Hospital Mortality

ICU Length of Stay

ICU Mortality

+7 more

COSMIC Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention - Cuff Leak TestExperimental Treatment2 Interventions

A respiratory therapist will perform a Cuff Leak Test on all patients prior to extubation. If no air leak is auscultated (a failed CLT), extubation will be delayed. During this time, the patient will receive dexamethasone 4mg intravenous every 6 hours for 12-24 hours and the clinical team will be advised to consider optimizing a patient's fluid status through either diuresis or ultrafiltration if the patient has renal failure. After 12-24 hours, and once the clinical team decides the patient is ready for another extubation attempt, the CLT will be repeated. If the patient fails the CLT again, it will be at the discretion of the clinical team how to proceed (i.e. continue steroid administration, and further delay extubation vs immediately extubating despite a failed CLT) (Figure 3). A passed CLT at any time point will result in immediate extubation.

Group II: Control - No Cuff Leak TestActive Control1 Intervention

In the control group, once the patient is deemed ready for extubation by the clinical team, the patient will be extubated without performing a CLT, without administration of corticosteroids, and without delay.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

FDA approved

Cuff Leak Test

2018

N/A

~690

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hamilton Academic Health Sciences OrganizationOTHER

20 Previous Clinical Trials

4,766 Total Patients Enrolled

St. Joseph's Healthcare HamiltonLead Sponsor

196 Previous Clinical Trials

25,444 Total Patients Enrolled

3 Trials studying Respiratory Failure

506 Patients Enrolled for Respiratory Failure

Kimberley Lewis, MDPrincipal InvestigatorSt. Joseph's Healthcare Hamilton

3 Previous Clinical Trials

1,150 Total Patients Enrolled

Media Library

Cuff Leak Test Clinical Trial Eligibility Overview. Trial Name: NCT05456542 — Phase 3

Respiratory Failure Research Study Groups: Intervention - Cuff Leak Test, Control - No Cuff Leak Test

Respiratory Failure Clinical Trial 2023: Cuff Leak Test Highlights & Side Effects. Trial Name: NCT05456542 — Phase 3

Cuff Leak Test 2023 Treatment Timeline for Medical Study. Trial Name: NCT05456542 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there risks associated with the Cuff Leak Test?

"There is some data to support the efficacy of Cuff Leak Test, as it is a Phase 3 trial. Furthermore, there are multiple rounds of data that support the safety of this medical intervention, so it received a score of 3."

Answered by AI

Are individuals currently being sought out for this research?

"No, this particular clinical trial is not recruiting at this time. Although the posting date was September 1st, 2022, the most recent update was on July 12th, 2022. There are, however, 201 other trials currently looking for candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients

Kimberley Lewis 2023. "Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05456542.