Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Niall Ferguson

ORCID ID

Contact details

Toronto Western Hospital
399 Bathurst St.
2MCL-411M
Toronto
M5T 2S8
Canada
+1 416 603 6203
n.ferguson@utoronto.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01506401

Protocol/serial number

MCT-94829

Study information

Scientific title

High frequency oscillation versus best current conventional ventilation to reduce acute respiratory distress syndrome (ARDS) mortality: a multicentre randomised controlled trial

Acronym

OSCILLATE

Study hypothesis

What is the effect of early high frequency oscillation (HFO) versus best current conventional ventilation (CV) using HFO only as rescue therapy, on all-cause hospital mortality among patients with severe early acute respiratory distress syndrome (ARDS)?

Please note that as of 29/08/2012, this trial is no longer recruiting patients.

Ethics approval

1. University Health Network (University of Toronto) - approval pending as of 11/05/2009
2. Hamilton Health Sciences (McMaster University) - approval pending as of 11/05/2009

All other centres will seek ethics approval before recruiting participants.

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute respiratory distress syndrome (ARDS)

Intervention

Intervention group: high frequency oscillatory (HFO) ventilation using a lung-open approach and an explicit protocol.
Control group: conventional ventilation using low tidal volumes, a lung-open approach and an explicit protocol, and utilising HFO only as true rescue therapy.

Contact details for joint Principal Investigator:
Dr Maureen Meade
McMaster University
Faculty of Health Sciences
Department of Clinical Epidemiology & Biostatistics, HSC-2C12
1200 Main St W
Hamilton, Ontario
L8N 3Z5
Canada
Tel: +1 905 525 9140 ext. 22160
Fax: +1 905 524 3841
Email: meadema@hhsc.ca

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

All-cause in-hospital mortality

Secondary outcome measures

1. Mortality at other time-points (ICU discharge, 28-day)
2. Barotrauma
3. Organ dysfunction
4. Duration of mechanical ventilation
5. Duration of ICU and hospital stay
6. Quality of life at 6 months

Overall trial start date

01/06/2009

Overall trial end date

01/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Acute onset of respiratory failure, with fewer than 2 weeks of new pulmonary symptoms
2. Endotracheal intubation or tracheostomy
3. Hypoxaemia - defined as a partial pressure of oxygen in arterial blood (PaO2)/fraction of inspired oxygen (FiO2) less than or equal to 200 mmHg on FiO2 greater than or equal to 0.5, regardless of positive end expiratory pressure (PEEP)
4. Bilateral alveolar consolidation (airspace disease) seen on frontal chest radiograph
5. Aged 16 years or over, either sex. No upper age limit.

In addition, to qualify for randomisation, patients are assessed on the following ventilator settings:
6. Mode: pressure control or volume control or pressure support
7. FiO2 greater than 0.6 (or higher if necessary to keep pulse oximetric saturation [SpO2] greater than 90%)
8. PEEP greater than 10 cm H2O (or greater if necessary to keep SpO2 greater than 90%)
9. Tidal volume 6 ml/kg predicted body weight (PBW)

After at least 30 minutes on these settings, we sample arterial blood to assess oxygenation. If PaO2 is less than or equal to 200 mmHg, the patient qualifies for randomisation; if PaO2/FiO2 greater than 200 mmHg, standardised hypoxaemia assessments are repeated at least once daily for the following 72 hours (providing the eligibility criteria are still met).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1200 (actual number recruited by end of recruitment on 29/08/2012: 548)

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 circulatory overload due to, for example, congestive heart failure, hyper-resuscitation, or need for dialysis
3. Suspected pulmonary haemorrhage syndrome
4. Lack of commitment to ongoing life support (note that this does not include the presence of a "Do Not Resuscitate" order alone, if there is a commitment to ongoing life support)
5. Aged less than 16 years
6. Weight less than 35 kg
7. Severe chronic respiratory disease, as indicated by any of:
7.1. Baseline forced expriatory volume in one second (FEV1) less than 20 ml/kg predicted body weight
7.2. Pre-existing chronic interstitial lung disease with chronic interstitial infiltration on chest X-ray
7.3. Documented chronic carbon dioxide (CO2) retention (partial pressure of carbon dioxide in arterial blood [PaCO2] less than 50 mmHg) and/or chronic hypoxaemia (PaO2 less than 55 mmHg on FiO2 = 0.21)
7.4. Chronic restrictive, obstructive, neuromuscular, chest wall or pulmonary vascular disease resulting in severe exercise restriction (e.g., unable to climb stairs or perform household duties), secondary polycythaemia, severe pulmonary hypertension (mean pulmonary artery pressure [PAP] greater than 40 mmHg), or ventilator dependency
8. Morbid obesity - defined as greater than 1 kg/cm body height
9. Underlying pre-existing condition with expected 6-month mortality greater than 50%
10. Neurological conditions with risk of intracranial hypertension (where hypercapnia should be avoided)
11. Neuromuscular disease that will result in prolonged need for mechanical ventilation, including (but not limited to):
11.1. Guillain Barré syndrome
11.2. Cervical spinal cord injury
12. Previous randomisation in this trial
13. All inclusion criteria present for greater than 72 hours in study intensive care unit (ICU)
14. On HFO at the time of screening

Recruitment start date

01/06/2009

Recruitment end date

01/12/2013

Locations

Countries of recruitment

Canada, Chile, France, Germany, India, Saudi Arabia, Singapore, Spain, United Kingdom, United States of America

Trial participating centre

Toronto Western Hospital
Toronto
M5T 2S8
Canada

Sponsor information

Organisation

Canadian Critical Care Trials Group (Canada)

Sponsor details

c/o Dr. John Marshall
St. Michael's Hospital
Toronto
M5M 27K
Canada
caone@smh.toronto.on.ca

Sponsor type

Research organisation

Website

http://www.ccctg.ca

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - www.cihr-irsc.gc.ca (ref: MCT-94829)

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.

Editorial Notes