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

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
McMaster University
University of Toronto
Information provided by:
Canadian Critical Care Trials Group
ClinicalTrials.gov Identifier:
NCT00474656
First received: May 15, 2007
Last updated: January 29, 2009
Last verified: January 2009
  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: 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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
St. Joseph's Hospital
Hamilton, Ontario, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
Mt Sinai Hospital
Toronto, Ontario, Canada
St Michael's Hospital
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Sunnybrook Health Science Centre
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

No publications provided by Canadian Critical Care Trials Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00474656     History of Changes
Other Study ID Numbers: 164451
Study First Received: May 15, 2007
Last Updated: January 29, 2009
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 18, 2014