The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study

Study Overview
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Brief Summary
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Acute respiratory distress syndrome (ARDS) is a common and catastrophic complication of critical illness related to burns, motor vehicle accidents, or overwhelming infection. ARDS kills 40-70% of affected patients. Patients with ARDS require life support in the form of a ventilator to breathe for them while their lungs heal. Ironically, ventilators can cause further damage to the lungs. We are conducting a study comparing 2 methods to protect the lungs from further damage. One method uses standard mechanical ventilators and the other uses a new type of ventilator, called a high frequency oscillator. We propose to test whether this high frequency oscillation will reduce the relative risk of dying from ARDS. 72 patients from 12 intensive care units in Canada and Saudi Arabia will participate in this preliminary study to test the feasibility of our study methods. If feasible, we plan to move on and conduct a large multinational study to definitively answer this question.

Official Title
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The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study

Conditions
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Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Device: High-frequency oscillation
* Device: Conventional lung-open mechanical ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of either sex, 16 years and above; Acute onset of respiratory failure, with fewer than 2 weeks of new pulmonary symptoms; Endotracheal intubation or tracheostomy; Hypoxaemia - defined as a PaO2/FiO2 ≤ 200 mm Hg; Bilateral alveolar consolidation (airspace disease) seen on frontal chest radiograph Exclusion Criteria: Remaining duration of mechanical ventilation < 48 hours, as judged by the attending physician; Primary cause of acute respiratory failure judged by attending physician to be cardiac in origin; Lack of commitment to ongoing life support; Weight < 35 kg; Severe chronic respiratory disease Morbid obesity - defined as > 1 kg / cm body height; Neurological conditions with risk of intracranial hypertension (hypercapnia should be avoided); Neuromuscular disease that will result in prolonged need for mechanical ventilation; Previous enrolment in this trial; All inclusion criteria present for > 72 hours; On HFO at the time of screening.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: High-frequency oscillation|nan|
|Device: Conventional lung-open mechanical ventilation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adherence to our explicit mechanical ventilation protocols; |  | duration of mechanical ventilation | 
| to measure and understand the reasons for crossovers between groups |  | duration of mechanical ventilation | 
| to estimate the rate of patient recruitment, and understand barriers to recruitment |  |  | 
| to document our ability to achieve close to complete follow-up for mortality and quality of life in the 6 months following enrolment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high frequency oscillation, lung-protective ventilation, ARDS, ventilator-induced lung injury