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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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30 March 2020 |
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Main ID: |
ISRCTN24242669 |
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Date of registration:
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12/05/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Randomised prospective European Multicenter Oscillator Acute Respiratory Distress Syndrome (ARDS) Trial
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Scientific title:
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Randomised prospective European Multicenter Oscillator Acute Respiratory Distress Syndrome (ARDS) Trial |
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Date of first enrolment:
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01/10/1997 |
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Target sample size:
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61 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN24242669 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Not Specified
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Countries of recruitment
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France
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Germany
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Adrianus
Van Vught |
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Address:
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P.O. Box 85090
3508 AB
Utrecht
Netherlands |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Patients with ARDS, defined as:
1.1. The pressure of arterial oxygen divided by the fraction of inspired oxygen (paO2/FiO2) less than 200 mmHg
1.2. Radiographic evidence of bilateral infiltrates on chest X-ray
1.3. No evidence of atrial hypertension
2. Body weight greater than 35 kg
Exclusion criteria:
1. Non-pulmonary terminal disease
2. Severe chronic obstructive pulmonary disease
3. Asthma and grade 3 or 4 air-leak
4. FiO2 greater than 0.80 for 48 hours
5. More than 10 days of mechanical ventilation
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Acute respiratory distress syndrome (ARDS)
Respiratory
Acute respiratory distress syndrome (ARDS)
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Intervention(s)
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High frequency oscillatory ventilation (HFOV) compared with conventional mechanical ventilation (CMV).
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Primary Outcome(s)
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1. Cumulative survival without mechanical ventilation or oxygen dependency at 30 days
2. Mortality at 30 days
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Secondary Outcome(s)
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1. Therapy failure
2. Crossover rate
3. Persisting pulmonary problems defined as oxygen dependency or still being on a ventilator at 30 days
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Source(s) of Monetary Support
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SensorMedics (USA)
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Ethics review
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Status:
Approval date:
Contact:
This study was approved by the ethical committee board of all participating institutions and was in compliance with the Helsinki Declaration.
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/03/2001 |
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URL:
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