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Conventional positive pressure ventilation or High Frequency Oscillatory Ventilation (HFOV) for adults with acute respiratory distress syndrome
DOI 10.1186/ISRCTN10416500
ClinicalTrials.gov identifier
EudraCT number
Public title Conventional positive pressure ventilation or High Frequency Oscillatory Ventilation (HFOV) for adults with acute respiratory distress syndrome
Scientific title
Acronym OSCAR: High Frequency OSCillation in ARDS
Serial number at source HTA 06/04/01; Version 4 - 12 June 2007 (not final)
Study hypothesis Patients with Acute Respiratory Distress Syndrome (ARDS) treated with high frequency oscillatory ventilation will have a decreased mortality at 30 days following randomisation compared with patients treated with conventional positive pressure ventilation.
Lay summary Lay summary under review 3
Ethics approval To be submitted as of 13 June 2007.
Study design A collaborative randomised controlled trial.
Countries of recruitment United Kingdom
Disease/condition/study domain Adults with acute respiratory distress syndrome. Intensive/critical care.
Participants - inclusion criteria 1. Age >=16 years
2. Weight >=35 kg
3. Endotracheal intubation or tracheostomy
4. Hypoxaemia defined as an arterial oxygen tension/inspired oxygen ratio (PaO2/FiO2) ratio ≤26.7kPa (200 mmHg), with a Positive End Expiratory Pressure (PEEP) ≥ 5 cmH20, determined on two arterial blood samples 12 hours apart
5. Bilateral infiltrates on chest radiograph
6. One or more risk factors for ARDS (including pneumonia, aspiration of gastric contents, inhalation injury, sepsis, major trauma, multiple transfusions, drug overdose, burn injury, acute pancreatitis, or shock)
7. Predicted to require at least 48 hours of artificial ventilation from the time of randomisation
Participants - exclusion criteria 1. Patients who could not benefit from HFOV
1.1. Patients with left atrial hypertension from any cause, diagnosed clinically or with echocardiography or pulmonary artery catheterisation
1.2. Patients who have been mechanically ventilated for more than 7 days at the point of enrollment

2. Patients in whom HFOV might be hazardous
2.1. Patients with airway disease expected to cause expiratory airflow limitation
2.2. Patients who have had a lung biopsy or resection during this hospital admission

3. Administrative, practical and ethical exclusions
3.1. Patients previously enrolled in the OSCAR trial during the same hospital admission
3.2.Patients refusing consent or patients in whom relatives refuse assent
3.3. Patients who were ‘legally incompetent’ prior to their hospital admission
3.4. Patients whose relatives do not understand written or verbal information for whom an interpreter is not available
3.5. Patients enrolled in another therapeutic trial in the 30 days prior to randomisation
3.6. Patients in whom active treatment has been withdrawn or withdrawal is planned
Anticipated start date 01/06/2007
Anticipated end date 29/02/2012
Status of trial Completed
Patient information material
Target number of participants 1,006
Interventions Group 1: Conventional positive pressure ventilation
Group 2: High Frequency Oscillatory Ventilation (HFOV)
Primary outcome measure(s) Mortality (all causes) at day 30
Secondary outcome measure(s) 1. Mortality rate at first discharge from ICU
2. Mortality rate at first discharge from hospital
3. Mortality rate one year after randomisation
4. Non-pulmonary organ failures whilst treated on an intensive care unit
5. Health-related quality of life six months after randomisation
6. Health-related quality of life one year after randomisation
7. Pulmonary function one year after randomisation
8. Cognitive function one year after randomisation
9. In addition there are health care system outcomes:
9.1. Primary: health cost per quality-adjusted life year gained one year after randomisation
9.2. Secondary health care system benefits: Intensive care unit length of stay, hospital length of stay
10. Utilisation of hospital resources after acute hospital discharge one year after randomisation
11. Utilisation of community care resources after acute hospital discharge one year after randomisation
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23339638
Contact name Dr  J Duncan  Young
  Address OSCAR Trial Office
Kadoorie Centre for Critical Care Research and Education
John Radcliffe Hospital
  City/town Oxford
  Zip/Postcode OX3 9DU
  Country United Kingdom
  Tel +44 (0)1865 220621
  Fax +44 (0)1865 220846
  Email OSCAR.Trial@nda.ox.ac.uk
Sponsor Oxford University (UK)
  Address Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
  City/town Oxford
  Zip/Postcode OX3 9DU
  Country United Kingdom
  Tel +44 (0)1865 743003
  Fax +44 (0)1865 743002
  Email heather.house@admin.ox.ac.uk
  Sponsor website: http://www.admin.ox.ac.uk/rso/contactus/ctrg.shtml
Date applied 13/06/2007
Last edited 09/05/2013
Date ISRCTN assigned 13/06/2007
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