Condition category
Respiratory
Date applied
31/05/2007
Date assigned
31/05/2007
Last edited
20/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.mcmaster.ca/

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

  1. 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.

Additional files

Editorial Notes