Respiratory Failure
Conditions
Keywords
Laryngeal Edema, Mechanical Ventilation, Cuff Leak Test
Brief summary
The COSMIC trial will be a multicentred, national, parallel-group, pragmatic vanguard pilot trial.
Detailed description
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).
Interventions
DIAGNOSTIC_TESTCuff Leak Test
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.
DRUGDexamethasone 4mg
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
Sponsors
Hamilton Academic Health Sciences Organization
St. Joseph's Healthcare Hamilton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
The Research Coordinator will randomize eligible patients in a 1:1 allocation using undisclosed variable block sizes through a central computer system on REDCap. Randomization algorithm will stratify patients by recruitment site. This is an unblinded study as group allocation will be known. However, outcome adjudicators and the study statistician will be blinded to the group allocation.
Intervention model description
Multicentred, national, parallel-group, pragmatic vanguard pilot trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protocol Adherence | 30 days | 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). |
| Recruitment Rate | 1 Year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with Post-extubation stridor | within 72 hours of extubation | Defined as the presence of an inspiratory noise following extubation. |
| Proportion of patients with Emergency Surgical Airway | within 72 hours of extubation | A procedure performed to secure the airway in patients with upper airway obstruction who could not be managed with intubation or mechanical ventilation. |
| ICU Mortality | Within 30 days of Randomization | Death during Intensive Care Unit admission |
| Hospital Mortality | Within 30 days of Randomization | Death during Intensive Care Unit admission |
| Proportion of patients with Clinically Significant post-extubation stridor | within 72 hours of extubation; | Defined as the presence of an inspiratory noise following extubation that requires medical intervention such as racemic epinephrine |
| ICU Length of Stay | Within 30 days of Randomization | Number of days admitted to the ICU |
| Length of Stay | Within 30 days of Randomization | Number of days admitted to hospital |
| Proportion of patients with Ventilator Associated Pneumonia | 30 Days from Randomization | Pneumonia occurring more than 48 h after patients have been intubated and received mechanical ventilation. |
| Ventilator Free Days | Within 30 Days of Randomization | Number of days alive and free of mechanical ventilation. |
| Proportion of patients Reintubation | within 72 hours of extubation; | Re insertion of an endotracheal tube to maintain an airway within 72 hours for any reason (reasons for reintubation will be captured) |
Countries
Canada, Kuwait, United States
Outcome results
None listed