Randomised prospective European Multicenter Oscillator Acute Respiratory Distress Syndrome (ARDS) Trial

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Adrianus Van Vught
Scientific

P.O. Box 85090
Utrecht
3508 AB
Netherlands

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Randomised prospective European Multicenter Oscillator Acute Respiratory Distress Syndrome (ARDS) Trial
Study acronym	EMOAT - European Multicenter Oscillator ARDS Trial
Study objectives	To compare the safety and efficacy of high frequency oscillatory ventilation (HFOV) with conventional mechanical ventilation (CMV) for early intervention in adult respiratory distress syndrome (ARDS).
Ethics approval(s)	This study was approved by the ethical committee board of all participating institutions and was in compliance with the Helsinki Declaration.
Health condition(s) or problem(s) studied	Acute respiratory distress syndrome (ARDS)
Intervention	High frequency oscillatory ventilation (HFOV) compared with conventional mechanical ventilation (CMV).
Intervention type	Other
Primary outcome measure(s)	1. Cumulative survival without mechanical ventilation or oxygen dependency at 30 days 2. Mortality at 30 days
Key secondary outcome measure(s)	1. Therapy failure 2. Crossover rate 3. Persisting pulmonary problems defined as oxygen dependency or still being on a ventilator at 30 days
Completion date	31/03/2001

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	61
Key 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
Key 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
Date of first enrolment	01/10/1997
Date of final enrolment	31/03/2001

P.O. Box 85090

Utrecht
3508 AB
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/08/2005		Yes	No

13/03/2020: Internal review.