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The oscillation for Acute Respiratory Distress Syndrome (ARDS) treated early (OSCILLATE) pilot study
ISRCTN ISRCTN42992782
DOI 10.1186/ISRCTN42992782
ClinicalTrials.gov identifier NCT00474656
EudraCT number
Public title The oscillation for Acute Respiratory Distress Syndrome (ARDS) treated early (OSCILLATE) pilot study
Scientific title High frequency oscillation versus lung-protective ventilation using conventional ventilators to reduce Acute Respiratory Distress Syndrome (ARDS) mortality: a randomised, parallel, two armed, multicentre pilot trial
Acronym OSCILLATE Pilot
Serial number at source MCT-82966
Study hypothesis This is a pilot study to test the feasibility of a larger trial for which we hypothesise that high frequency oscillation will reduce acute respiratory distress syndrome (ARDS) mortality compared to lung-protective ventilation using conventional ventilators.
Lay summary Not provided at time of registration
Ethics approval Research Ethics Board of University Health Network, Toronto, Ontario (Canada) approved on the 3rd May 2007 (ref: 07-0158-B)
Study design Randomised, parallel, two armed, multicentre trial in therapeutic management strategy, with data analysts blinded
Countries of recruitment Canada
Disease/condition/study domain Acute respiratory distress syndrome (ARDS)
Participants - inclusion criteria 1. Patients of either sex, 16 years and above
2. Acute onset of respiratory failure, with fewer than two weeks of new pulmonary symptoms
3. Endotracheal intubation or tracheostomy
4. Hypoxaemia: defined as a partial pressure of oxygen in arterial blood (PaO2)/fraction of inspired oxygen (FiO2) ratio of less than or equal to 200 mmHg
5. Bilateral alveolar consolidation (airspace disease) seen on frontal chest radiograph
Participants - exclusion criteria 1. Remaining duration of mechanical ventilation less than 48 hours, as judged by the attending physician
2. Primary cause of acute respiratory failure judged by attending physician to be cardiac in origin
3. Lack of commitment to ongoing life support
4. Weight less than 35 kg
5. Severe chronic respiratory disease
6. Morbid obesity: defined as greater than 1 kg/cm body height
7. Neurological conditions with risk of intracranial hypertension (hypercapnia should be avoided)
8. Neuromuscular disease that will result in prolonged need for mechanical ventilation
9. Previous enrolment in this trial
10. All inclusion criteria present for greater than 72 hours
11. On high frequency oscillator (HFO) at the time of screening
Anticipated start date 01/05/2007
Anticipated end date 31/07/2008
Status of trial Completed
Patient information material
Target number of participants 60
Interventions 1. High frequency oscillation (HFO): duration of mechanical ventilation
2. Lung open ventilation: duration of mechanical ventilation

Co-investigator for Public and Scientific Queries:
Dr Niall D Ferguson
Toronto Western Hospital
399 Bathurst Street
F2-150
Toronto, Ontario
M5T 2S8
Canada
Tel: +1 416 603 6203
Fax: +1 416 603 5870
Email: n.ferguson@utoronto.ca
Primary outcome measure(s) 1. Feasibility at one-year of study. The three feasibility outcomes for the OSCILLATE pilot study will be evaluated as follows:
1.1. We will consider adherence to our explicit mechanical ventilation protocols to be adequate if more than 80% of patients (approximately 24/30) have fewer than 10% of monitored values (excluding crossover periods) as major protocol violations
1.2. We will consider the number of crossovers to be acceptable if fewer than 10% of patients cross over to the alternate ventilator, when not allowed by protocol
1.3. We will consider patient accrual to be adequate if we recruit 60 patients from 10 sites over one-year
Secondary outcome measure(s) No secondary outcome measures
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - www.cihr-irsc.gc.ca (ref: MCT-82966)
Trial website
Publications 1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23339639
Contact name Dr  Maureen  Meade
  Address McMaster University
Hamilton Health Sciences Centre, Rm. 2C9
1200 Main Street
Hamilton
  City/town Ontario
  Zip/Postcode L8N 3Z5
  Country Canada
  Tel +1 905 525 9140 ext. 22900
  Fax +1 905 524 3842
  Email meadema@hhsc.ca
Sponsor McMaster University (Canada)
  Address c/o Mrs Peggy Austin
1200 Main Street West
Hamilton
  City/town Ontario
  Zip/Postcode L8N 3Z5
  Country Canada
  Tel +1 905 525 9140
  Fax +1 905 570 0742 (RESEARCH)
  Email austinp@mcmaster.ca
  Sponsor website: http://www.mcmaster.ca/
Date applied 31/05/2007
Last edited 20/02/2013
Date ISRCTN assigned 31/05/2007
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