Condition category
Respiratory
Date applied
13/06/2007
Date assigned
13/06/2007
Last edited
09/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

Trial website

Contact information

Type

Scientific

Primary contact

Dr J Duncan Young

ORCID ID

Contact details

OSCAR Trial Office
Kadoorie Centre for Critical Care Research and Education
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 220621
OSCAR.Trial@nda.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 06/04/01; Version 4 - 12 June 2007 (not final)

Study information

Scientific title

Acronym

OSCAR: High Frequency OSCillation in ARDS

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.

Ethics approval

To be submitted as of 13 June 2007.

Study design

A collaborative randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Adults with acute respiratory distress syndrome. Intensive/critical care.

Intervention

Group 1: Conventional positive pressure ventilation
Group 2: High Frequency Oscillatory Ventilation (HFOV)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Mortality (all causes) at day 30

Secondary outcome measures

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

Overall trial start date

01/06/2007

Overall trial end date

29/02/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1,006

Participant 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

Recruitment start date

01/06/2007

Recruitment end date

29/02/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

OSCAR Trial Office
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

Oxford University (UK)

Sponsor details

Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 743003
heather.house@admin.ox.ac.uk

Sponsor type

University/education

Website

http://www.admin.ox.ac.uk/rso/contactus/ctrg.shtml

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

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/23339638

Publication citations

  1. Results

    Young D, Lamb SE, Shah S, MacKenzie I, Tunnicliffe W, Lall R, Rowan K, Cuthbertson BH, , High-frequency oscillation for acute respiratory distress syndrome., N. Engl. J. Med., 2013, 368, 9, 806-813, doi: 10.1056/NEJMoa1215716.

Additional files

Editorial Notes