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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00474656
First Posted: May 17, 2007
Last Update Posted: January 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Canadian Institutes of Health Research (CIHR)
McMaster University
University of Toronto
Information provided by:
Canadian Critical Care Trials Group
May 15, 2007
May 17, 2007
January 30, 2009
June 2007
July 2008   (Final data collection date for primary outcome measure)
  • adherence to our explicit mechanical ventilation protocols; [ Time Frame: duration of mechanical ventilation ]
  • to measure and understand the reasons for crossovers between groups [ Time Frame: 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
Same as current
Complete list of historical versions of study NCT00474656 on ClinicalTrials.gov Archive Site
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The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study
The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study
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.
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Respiratory Distress Syndrome
  • Device: High-frequency oscillation
  • Device: Conventional lung-open mechanical ventilation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
December 2008
July 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Saudi Arabia
 
 
NCT00474656
164451
Yes
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Canadian Critical Care Trials Group
  • Canadian Institutes of Health Research (CIHR)
  • McMaster University
  • University of Toronto
Principal Investigator: Niall D Ferguson, MD, MSc University of Toronto
Principal Investigator: Maureen O Meade, MD, MSc McMaster University
Canadian Critical Care Trials Group
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP