Condition category
Respiratory
Date applied
23/11/2004
Date assigned
12/05/2005
Last edited
06/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Adrianus Van Vught

ORCID ID

Contact details

P.O. Box 85090
Utrecht
3508 AB
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

EMOAT - European Multicenter Oscillator ARDS Trial

Study hypothesis

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

This study was approved by the ethical committee board of all participating institutions and was in compliance with the Helsinki Declaration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Acute respiratory distress syndrome (ARDS)

Intervention

High frequency oscillatory ventilation (HFOV) compared with conventional mechanical ventilation (CMV).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Cumulative survival without mechanical ventilation or oxygen dependency at 30 days
2. Mortality at 30 days

Secondary outcome measures

1. Therapy failure
2. Crossover rate
3. Persisting pulmonary problems defined as oxygen dependency or still being on a ventilator at 30 days

Overall trial start date

01/10/1997

Overall trial end date

31/03/2001

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

61

Participant 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

Recruitment start date

01/10/1997

Recruitment end date

31/03/2001

Locations

Countries of recruitment

France, Germany, United Kingdom

Trial participating centre

P.O. Box 85090
Utrecht
3508 AB
Netherlands

Sponsor information

Organisation

SensorMedics (USA)

Sponsor details

22705 Savi Ranch Parkway
Yorba Linda
CA 92687
United States of America

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

SensorMedics (USA)

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/16137357

Publication citations

  1. Results

    Bollen CW, van Well GT, Sherry T, Beale RJ, Shah S, Findlay G, Monchi M, Chiche JD, Weiler N, Uiterwaal CS, van Vught AJ, High frequency oscillatory ventilation compared with conventional mechanical ventilation in adult respiratory distress syndrome: a randomized controlled trial [ISRCTN24242669]., Crit Care, 2005, 9, 4, R430-9, doi: 10.1186/cc3737.

Additional files

Editorial Notes