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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
  Purpose
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.

Condition Intervention
Acute Respiratory Distress Syndrome Device: High-frequency oscillation Device: Conventional lung-open mechanical ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study

Resource links provided by NLM:


Further study details as provided by Canadian Critical Care Trials Group:

Primary Outcome Measures:
  • 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

Enrollment: 94
Study Start Date: June 2007
Study Completion Date: December 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474656


Locations
Canada, Alberta
University of Alberta Medical Centre
Edmonton, Alberta, Canada
Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada
St Paul's Hospital
Vancouver, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Canada, Ontario
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
Saudi Arabia
King Fahad National Guard Hospital
Riyadh, Saudi Arabia
Sponsors and Collaborators
Canadian Critical Care Trials Group
Canadian Institutes of Health Research (CIHR)
McMaster University
University of Toronto
Investigators
Principal Investigator: Niall D Ferguson, MD, MSc University of Toronto
Principal Investigator: Maureen O Meade, MD, MSc McMaster University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00474656     History of Changes
Other Study ID Numbers: 164451
First Submitted: May 15, 2007
First Posted: May 17, 2007
Last Update Posted: January 30, 2009
Last Verified: January 2009

Keywords provided by Canadian Critical Care Trials Group:
high frequency oscillation
lung-protective ventilation
ARDS
ventilator-induced lung injury

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury