The oscillation for acute respiratory distress syndrome (ARDS) treated early trial

ISRCTN	ISRCTN87124254
DOI	https://doi.org/10.1186/ISRCTN87124254
ClinicalTrials.gov (NCT)	NCT01506401
Protocol serial number	MCT-94829
Sponsor	Canadian Critical Care Trials Group (Canada)
Funder	Canadian Institutes of Health Research

Submission date: 30/04/2009
Registration date: 11/05/2009
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 Niall Ferguson
Scientific

Toronto Western Hospital
399 Bathurst St., 2MCL-411M
Toronto
M5T 2S8
Canada

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

Dr Maureen Meade
Scientific

McMaster University
Faculty of Health Sciences
Department of Clinical Epidemiology & Biostatistics, HSC-2C12
1200 Main St W
Hamilton
L8N 3Z5
Canada

Phone	+1 (0)905 525 9140 ext. 22160
Email	meadema@hhsc.ca

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	High frequency oscillation versus best current conventional ventilation to reduce acute respiratory distress syndrome (ARDS) mortality: a multicentre randomised controlled trial
Study acronym	OSCILLATE
Study objectives	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)?
Ethics approval(s)	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.
Health condition(s) or problem(s) studied	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.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	All-cause in-hospital mortality
Key secondary outcome measure(s)	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
Completion date	01/12/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1200
Key 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).
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 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
Date of first enrolment	01/06/2009
Date of final enrolment	29/08/2012

Locations

Countries of recruitment

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

Study participating centre

Toronto Western Hospital

Toronto
M5T 2S8
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.