The COSMIC trial will be a multicentred, national, parallel-group, pragmatic vanguard pilot trial.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
100
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, 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
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Brantford General Hospital
Brantford, Ontario, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Niagara Health System
Saint Catherines, Ontario, Canada
Protocol Adherence
Define a successful adherence rate as ≥75%. We will calculate the adherence as the proportion of patients that are assigned to the intervention arm following the appropriate treatment algorithm and those assigned to the control arm being extubated without a cuff leak test. As this pilot trial is ongoing, we will review adherence monthly and investigate the reasons for compliance failure. We will investigate all reasons for failure to follow the treatment algorithm in the intervention arm, failure to extubate after a patient passes a CLT in the intervention arm, or failure to extubate immediately after randomization in the control arm and report them as a protocol violation. The RC will review the RT's charting and the medication profile to determine actual compliance. RC will record all reasons for non-compliance using distinguishing clinical reasons (eg, palliation, death, consent withdrawal and errors).
Time frame: 30 days
Recruitment Rate
Define a successful recruitment rate as enrolling three patients per centre per month over the duration of the trial. While the pilot trial is ongoing, steering committee will review recruitment weekly and the screening records monthly. If applicable, we will address barriers to enrolment to maximise recruitment. The recruitment metric will be measured and interpreted at the end of the pilot trial by calculating the mean number of recruited patients per active screening month.
Time frame: 1 Year
Proportion of patients with Clinically Significant post-extubation stridor
Defined as the presence of an inspiratory noise following extubation that requires medical intervention such as racemic epinephrine
Time frame: within 72 hours of extubation;
Proportion of patients Reintubation
Re insertion of an endotracheal tube to maintain an airway within 72 hours for any reason (reasons for reintubation will be captured)
Time frame: within 72 hours of extubation;
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Al-Amiri Hospital
Kuwait City, Kuwait
Proportion of patients with Post-extubation stridor
Defined as the presence of an inspiratory noise following extubation.
Time frame: within 72 hours of extubation
Proportion of patients with Emergency Surgical Airway
A procedure performed to secure the airway in patients with upper airway obstruction who could not be managed with intubation or mechanical ventilation.
Time frame: within 72 hours of extubation
ICU Mortality
Death during Intensive Care Unit admission
Time frame: Within 30 days of Randomization
Hospital Mortality
Death during Intensive Care Unit admission
Time frame: Within 30 days of Randomization
Ventilator Free Days
Number of days alive and free of mechanical ventilation.
Time frame: Within 30 Days of Randomization
ICU Length of Stay
Number of days admitted to the ICU
Time frame: Within 30 days of Randomization
Length of Stay
Number of days admitted to hospital
Time frame: Within 30 days of Randomization
Proportion of patients with Ventilator Associated Pneumonia
Pneumonia occurring more than 48 h after patients have been intubated and received mechanical ventilation.
Time frame: 30 Days from Randomization