Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients

• Status: Not yet recruiting
• Trial end date: 2024-11-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Joseph's Healthcare Hamilton
• Collaborator: Hamilton Academic Health Sciences Organization
• Treatments: Dexamethasone

Criteria

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

• Patients with highly suspected laryngeal injury: Burn patients, smoke inhalation injuries, blunt or penetrating trauma of the neck and airway, recent head and neck surgeries, and patients admitted with airway edema

• Known pre-existing tracheolaryngeal abnormalities: Vocal cord paralysis, tracheolaryngeal neoplasm, tracheomalasia, tracheolaryngeal stenosis, or previous head and neck surgeries

• Mechanical ventilation via a tracheostomy

• High dose steroids administered within the previous 72h (Prednisone 1mg/kg oral equivalent)

• The ICU physician believes the patient should have a CLT performed

• Patient had a failed CLT in the previous 24 hours