Conventional positive pressure ventilation or High Frequency Oscillatory Ventilation (HFOV) for adults with acute respiratory distress syndrome

Not Applicable

Completed

• Conditions: Acute respiratory distress syndrome; Respiratory

• Registration Number: ISRCTN10416500
• Lead Sponsor: Oxford University (UK)

Brief Summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23339638 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25800686 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27525106 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31088354 (added 16/05/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-13
• Study Completion: 2012-02-29
• Last Update Posted: 27 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1006

Inclusion Criteria

1. Age 16 years and over
2. Weight 35 kg and over
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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality (all causes) at day 30