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 (0)416 603 6203
n.ferguson@utoronto.ca
Type
Scientific
Additional contact
Dr Maureen Meade
ORCID ID
Contact details
McMaster University
Faculty of Health Sciences
Department of Clinical Epidemiology & Biostatistics
HSC-2C12
1200 Main St W
Hamilton
L8N 3Z5
Canada
+1 (0)905 525 9140 ext. 22160
meadema@hhsc.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)?
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.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
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 (if study stopped)
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: 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
29/08/2012
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
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research
Alternative name(s)
Instituts de Recherche en Santé du Canada, CIHR, IRSC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Canada
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23339639
2015 eligible nonenrolled patients results in: http://www.ncbi.nlm.nih.gov/pubmed/26192398
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.
-
Results
Arabi YM, Cook DJ, Zhou Q, Smith O, Hand L, Turgeon AF, Matte A, Mehta S, Graham R, Brierley K, Adhikari NK, Meade MO, Ferguson ND; Canadian Critical Care Trials Group, Characteristics and Outcomes of Eligible Nonenrolled Patients in a Mechanical Ventilation Trial of Acute Respiratory Distress Syndrome, Am J Respir Crit Care Med, 2015 , 192, 11, 1306-1313, doi: 10.1164/rccm.201501-0172OC.