The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study
OSCILLATE
1 other identifier
interventional
94
2 countries
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2007
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2007
CompletedFirst Posted
Study publicly available on registry
May 17, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJanuary 30, 2009
January 1, 2009
1.1 years
May 15, 2007
January 29, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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;
- On HFO at the time of screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Canadian Critical Care Trials Grouplead
- Canadian Institutes of Health Research (CIHR)collaborator
- McMaster Universitycollaborator
- University of Torontocollaborator
Study Sites (12)
University of Alberta Medical Centre
Edmonton, Alberta, Canada
Royal Columbian Hospital
New Westminster, British Columbia, Canada
St Paul's Hospital
Vancouver, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
St. Joseph's Hospital
Hamilton, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
Mt Sinai Hospital
Toronto, Ontario, Canada
St Michael's Hospital
Toronto, Ontario, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
King Fahad National Guard Hospital
Riyadh, Saudi Arabia
Related Publications (2)
Arabi YM, Cook DJ, Zhou Q, Smith O, Hand L, Turgeon AF, Matte A, Mehta S, Graham R, Brierley K, Adhikari NK, Meade MO, Ferguson ND; Canadian Critical Care Trials Group. Characteristics and Outcomes of Eligible Nonenrolled Patients in a Mechanical Ventilation Trial of Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2015 Dec 1;192(11):1306-13. doi: 10.1164/rccm.201501-0172OC.
PMID: 26192398DERIVEDFerguson ND, Cook DJ, Guyatt GH, Mehta S, Hand L, Austin P, Zhou Q, Matte A, Walter SD, Lamontagne F, Granton JT, Arabi YM, Arroliga AC, Stewart TE, Slutsky AS, Meade MO; OSCILLATE Trial Investigators; Canadian Critical Care Trials Group. High-frequency oscillation in early acute respiratory distress syndrome. N Engl J Med. 2013 Feb 28;368(9):795-805. doi: 10.1056/NEJMoa1215554. Epub 2013 Jan 22.
PMID: 23339639DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Niall D Ferguson, MD, MSc
University of Toronto
- PRINCIPAL INVESTIGATOR
Maureen O Meade, MD, MSc
McMaster University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 15, 2007
First Posted
May 17, 2007
Study Start
June 1, 2007
Primary Completion
July 1, 2008
Study Completion
December 1, 2008
Last Updated
January 30, 2009
Record last verified: 2009-01