Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU (COMIC)
Laryngeal Edema
About this trial
This is an interventional diagnostic trial for Laryngeal Edema focused on measuring Cuff leak test, Post-extubation airway obstruction, Laryngeal edema
Eligibility Criteria
Inclusion Criteria:
- Eligible patients will be mechanically ventilated adults (>18 years) who are admitted to the ICU and an order to extubate has been provided by the treating physician.
Exclusion Criteria:
- A palliative care, a one-way extubation, or a decision to withdraw advances life support order has been written.
- Pregnancy.
- Patients at high risk for LE: burn patients, smoke inhalation injuries (as defined as singed facial hair or nasal hair, carbonaceous secretions/sputum, and known to be in an enclosed fire), blunt or penetrating trauma involving the neck and airway, postoperative head and neck surgeries, and patients admitted with airway edema to the ICU (e.g; anaphylaxis).
- Patients with either a difficult or traumatic endotracheal intubation.
- Patients receiving mechanical ventilation via tracheostomy.
- Known preexisting tracheolaryngeal abnormalities such as: vocal cord paralysis, tracheolaryngeal neoplasm, tracheomalacia, tracheolaryngeal stenosis, or previous head and neck surgeries.
- Patients receiving systemic corticosteroids of greater than 30 mg of PO prednisone or equivalent, within 4 days prior to the decision to extubate.
- Patients who failed extubation attempt within the current ICU admission.
- History of postextubation airway obstruction.
- The ICU physician declined enrolling the patient.
- Patient had a failed CLT in the previous 24 hours.
Sites / Locations
- St Joseph's Hospital
- Jagiellonian University Medical College
- Imam Adbulrahman Bin Faisal University
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention Arm
Control Arm
Patients randomized to the intervention arm will have the results of the Cuff Leak Test (CLT) (whether failed or passed) communicated to the treating physician; the treating physician will decide whether to proceed with extubation or not based on the CLT results. It is at the discretion of the treating physician to provide corticosteroids (4-5 mg of intravenous dexamethasone every six hours for up to 24 hours, with the last dose given one hour preceding extubation) and/or delay extubation by 24 hours should the patient fail the CLT.
In the control arm of this trial; the treating physicians and healthcare workers will be blinded to the results of the Cuff Leak Test (CLT); therefore, the Respiratory Therapist (RT) will proceed with extubation without delay or administering systemic steroid, regardless to the CLT results.