The oscillation for Acute Respiratory Distress Syndrome (ARDS) treated early (OSCILLATE) pilot study

ISRCTN	ISRCTN42992782
DOI	https://doi.org/10.1186/ISRCTN42992782
ClinicalTrials.gov (NCT)	NCT00474656
Protocol serial number	MCT-82966
Sponsor	McMaster University (Canada)
Funder	Canadian Institutes of Health Research (ref: MCT-82966)

Submission date: 31/05/2007
Registration date: 31/05/2007
Last edited: 06/04/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Maureen Meade
Scientific

McMaster University
Hamilton Health Sciences Centre, Rm. 2C9
1200 Main Street
Hamilton
Ontario
L8N 3Z5
Canada

Phone	+1 (0)905 525 9140 ext. 22900
Email	meadema@hhsc.ca

Dr Niall D Ferguson
Scientific

Toronto Western Hospital
399 Bathurst Street
F2-150
Toronto
M5T 2S8
Canada

Phone	+1 (0)416 603 6203
Email	n.ferguson@utoronto.ca

Study information

Primary study design	Interventional
Study design	Randomised parallel two-armed multicentre trial in therapeutic management strategy, with data analysts blinded
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	OSCILLATE Pilot
Study objectives	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(s)	Research Ethics Board of University Health Network, Toronto, Ontario (Canada), 03/05/2007, ref: 07-0158-B
Health condition(s) or problem(s) studied	Acute respiratory distress syndrome (ARDS)
Intervention	1. High frequency oscillation (HFO): duration of mechanical ventilation 2. Lung open ventilation: duration of mechanical ventilation
Intervention type	Other
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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	60
Key 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
Key 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
Date of first enrolment	01/05/2007
Date of final enrolment	31/07/2008

Locations

Countries of recruitment

Canada

Study participating centre

McMaster University

Ontario
L8N 3Z5
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	28/02/2013		Yes	No
Results article	eligible nonenrolled patients results	01/12/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

06/04/2016: Publication reference added.