Contact information
Type
Scientific
Primary contact
Dr Maureen Meade
ORCID ID
Contact details
McMaster University
Hamilton Health Sciences Centre
Rm. 2C9
1200 Main Street
Hamilton
Ontario
L8N 3Z5
Canada
+1 905 525 9140 ext. 22900
meadema@hhsc.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00474656
Protocol/serial number
MCT-82966
Study information
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
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Acute respiratory distress syndrome (ARDS)
Intervention
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
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 measures
No secondary outcome measures
Overall trial start date
01/05/2007
Overall trial end date
31/07/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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
Recruitment start date
01/05/2007
Recruitment end date
31/07/2008
Locations
Countries of recruitment
Canada
Trial participating centre
McMaster University
Ontario
L8N 3Z5
Canada
Sponsor information
Organisation
McMaster University (Canada)
Sponsor details
c/o Mrs Peggy Austin
1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada
+1 905 525 9140
austinp@mcmaster.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - www.cihr-irsc.gc.ca (ref: MCT-82966)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23339639
Publication citations
-
Results
Ferguson 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, , , High-frequency oscillation in early acute respiratory distress syndrome., N. Engl. J. Med., 2013, 368, 9, 795-805, doi: 10.1056/NEJMoa1215554.