Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients (NCT05456542) | Clinical Trial Compass
CompletedPhase 3
Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients
United States, Canada, Kuwait100 participantsStarted 2023-04-05
Plain-language summary
The COSMIC trial will be a multicentred, national, parallel-group, pragmatic vanguard pilot trial.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥18 yrs. of age
* Mechanically ventilated in the ICU \\
* An order to extubate has been provided by the treating physician
* Meet at least 1 criteria for risk factors for Laryngeal Edema(LE):
* Criteria 1
* Intubated for \>5 days
* Criteria 2 \*must fulfill category 1 and ≥1 risk factor in category 2
* Category 1
\- Intubated for \>48 hours
* Category 2
* An unplanned extubation event within the last week
* Airway trauma secondary to an endotracheal intubation during the past week defined as one of the following:
* More than one attempt at direct laryngoscopy
* More than one attempt to pass the ETT
* Charted as a traumatic intubation
* A body mass index of \>30kg/m2
* An endotracheal tube greater than 8mm in a man or 7mm in a woman
* A total positive cumulative fluid balance of at least \>1500ml/d x # of days admitted to ICU (eg. If admitted for 4 days, the patient will meet this criterion if they are 6L positive during their length of ICU admission)
* Physician concern about possible laryngeal edema for a reason not previously listed above. For example:
* Prone or Trendelenburg position in a recent operation
* Agitation defined as a RASS of 3+ or more or a SAS of 6 or more that may result in airway injury
Exclusion Criteria:
* Palliative care plan or plan of care does not include re-intubation, Decision to withdraw life support, or no plan for re-intubation
* Known pregnancy: Current pregnancy or up to and including 7 days postpartum
* …