Condition category
Respiratory
Date applied
23/10/2008
Date assigned
31/10/2008
Last edited
12/03/2010
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 Younsuck Koh

ORCID ID

Contact details

Division of Pulmonary and Critical Care Medicine
Asan Medical Center
College of Medicine
University of Ulsan
388-1 Pungnap-dong
Songpa-gu
Seoul
138-736
Korea
South

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

In the acute respiratory distress syndrome (ARDS), the right level of positive end-expiratory pressure (PEEP) may decrease ventilator-induced lung injury by opening the lung and keeping it open. We evaluated whether setting the PEEP using decremental PEEP titration after alveolar recruitment manoeuvre (ARM) affects the clinical outcome in patients with ARDS.

Ethics approval

The study protocol was approved by the Institutional Board of the Ethics Committee of Asan Medical Center on the 14th August 2006 (ref: 2006-0286)

Study design

Randomised, controlled, single centre study

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

Control group:
The FiO2-PEEP strategy has been used in previous ARDS Network studies. PEEP and FiO2 were set according to the table of lower PEEP/higher FiO2 combinations, with the goal of obtaining a lower PEEP level compatible with an oxygenation target.

Decremental PEEP titration group:
The alveolar recruitment manoeuvre (ARM) was performed immediately after enrolment in the study and was applied once a day in the morning for 1 week. After ARM, the decrease in PEEP was continued until a decrease of greater than 2% of the saturation from the previous SaO2 and drop of static compliance was identified (decremental PEEP titration).

Total duration of treatment: 1 week
Total duration of follow-up: from enrolment to leaving the hospital

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

28-day mortality

Secondary outcome measures

1. Duration of mechanical ventilation
2. Intensive Care Unit (ICU) stay
3. Use of paralysing or sedative agents

Measured until leaving the hospital.

Overall trial start date

01/06/2004

Overall trial end date

30/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Criteria of ARDS proposed by the American-European Consensus Conference:
1.1. Acute onset
1.2. Presence of hypoxaemia (arterial oxygen tension/fraction of inspired oxygen (FiO2) (PF ratio) less than 200 mmHg regardless of the PEEP level)
1.3. Bilateral and diffuse opacities seen on frontal chest X-ray film
1.4. Absence of left ventricular failure with pulmonary arterial occluded pressure less than 18 mmHg
2. Recruited into the trial within 48 hours of meeting above ARDS criteria
3. Aged 18 - 82 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100 patients

Participant exclusion criteria

1. Haemodynamic instability
2. Elevated intracranial pressure
3. High risk of mortality within 3 months from other than ARDS (severe organ failure, and cancer patients in terminal stages of the disease)
4. Refusal to participate

Recruitment start date

01/06/2004

Recruitment end date

30/09/2006

Locations

Countries of recruitment

Korea, South

Trial participating centre

Division of Pulmonary and Critical Care Medicine
Seoul
138-736
Korea, South

Sponsor information

Organisation

Asan Medical Center (South Korea)

Sponsor details

c/o Younsuck Koh
Division of Pulmonary and Critical Care Medicine
College of Medicine
University of Ulsan
388-1 Pungnap-dong
Songpa-gu
Seoul
138-736
Korea
South

Sponsor type

Hospital/treatment centre

Website

http://www1.amc.seoul.kr

Funders

Funder type

Hospital/treatment centre

Funder name

Asan Medical Center (South Korea) - the internal research fund of Intensive Care Units

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19239703

Publication citations

  1. Results

    Huh JW, Jung H, Choi HS, Hong SB, Lim CM, Koh Y, Efficacy of positive end-expiratory pressure titration after the alveolar recruitment manoeuvre in patients with acute respiratory distress syndrome., Crit Care, 2009, 13, 1, R22, doi: 10.1186/cc7725.

Additional files

Editorial Notes