Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients

Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients (COSMIC): A Pilot Randomized Controlled Trial

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).

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