Intervention - Cuff Leak Test for Choking

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
King Abdulaziz Medical City, Riyadh, Saudi Arabia
Choking+2 More
Dexamethasone 4mg - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

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

Eligible Conditions

  • Choking
  • Respiratory Failure

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 10 Secondary · Reporting Duration: 1 Year

1 Year
Recruitment Rate
30 Days from Randomization
Proportion of patients with Ventilator Associated Pneumonia
30 days
Protocol Adherence
Day 30
Ventilator Free Days
Day 30
Hospital Mortality
ICU Length of Stay
ICU Mortality
Length of Stay
Hour 72
Proportion of patients with Emergency Surgical Airway
Proportion of patients with Post-extubation stridor
Hour 72
Proportion of patients Reintubation
Proportion of patients with Clinically Significant post-extubation stridor

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Control - No Cuff Leak Test
1 of 2
Intervention - Cuff Leak Test
1 of 2
Active Control
Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Intervention - Cuff Leak Test · No Placebo Group · Phase 3

Intervention - Cuff Leak TestExperimental Group · 2 Interventions: Dexamethasone 4mg, Cuff Leak Test · Intervention Types: Drug, DiagnosticTest
Control - No Cuff Leak TestNoIntervention Group · 1 Intervention: Control - No Cuff Leak Test · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone 4mg
2017
Completed Phase 2
~140
Cuff Leak Test
2018
N/A
~100

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Trial Background

Prof. Kimberley Lewis, Principal Investigator, SJHH Staff Intensivist, Assistant Professor
Principal Investigator
St. Joseph's Healthcare Hamilton
Closest Location: Brantford General Hospital · Brantford, Canada
2007First Recorded Clinical Trial
0 TrialsResearching Choking
7 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have been intubated for >48 hours.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.