Condition category
Respiratory
Date applied
26/04/2005
Date assigned
26/04/2005
Last edited
27/07/2007
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

Dr Pierre Michelet

ORCID ID

Contact details

Département d'Anesthésie Réanimation
Sainte Marguerite Hospital
Marseille
13009
France
pierre.michelet@mail.ap-hm.fr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The aim of the present study was to investigate whether the evolution of Intra-Abdominal Pressure (IAP), liver function assessed by the Plasma Disappearance Rate of Indocyanine Green (PDRICG) and extravascular lung water is related to the type of support during PP. We therefore prospectively compared, in a population of medical-Acute Respiratory Distress Syndrome (ARDS) patients, the effects of an air-cushioned mattress and a conventional foam mattress during PP.

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Acute Respiratory Distress Syndrome (ARDS)

Intervention

Baseline measurements were performed in the supine position after one hour of steady-state conventional mechanical ventilation. Then the following two periods of PP were randomised:
1. 6 hours of PP on the moulded foam mattress
2. 6 hours of PP on the air-cushioned mattress

A period of 18 hours in the supine position separated the two periods in the prone position. Each patient was his or her own control. Measurements were achieved in the supine position, after 1 and 6 hours of PP.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Intra-Abdominal Pressure (IAP)
2. Plasma Disappearance Rate of Indocyanine Green (PDRICG)
3. Extravascular Lung Water (EVLW)
4. Partial Pressure of Oxygen in Arterial Blood (PaO2)/Fraction of Inspired Oxygen (FiO2) ratio
5. Central Venous Pressure (CVP)
6. Mean pulmonary arterial pressure
7. Pulmonary artery occlusion pressure

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/01/2003

Overall trial end date

01/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Twenty consecutive patients with ARDS were included and turned prone in the medical intensive care unit of Sainte Marguerite University Hospital in Marseille, France. Patients were prospectively included in this study after obtaining written informed consent from the next of kin. The study design was approved by the Comité Consultatif de Protection des Personnes dans la Recherche Biomédicale of Marseille. ARDS was defined in accordance with the recommendations of the American/European Consensus Conference.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

Patients with unstable cardiovascular function, cerebral injury or unstable spinal fractures, patients subjected to major abdominal surgery and patients with a history of neuromuscular disease were excluded.

Recruitment start date

01/01/2003

Recruitment end date

01/01/2004

Locations

Countries of recruitment

France

Trial participating centre

Département d'Anesthésie Réanimation
Marseille
13009
France

Sponsor information

Organisation

Sainte Marguerite Hospital (France)

Sponsor details

-
Marseille
13009
France
pierre.michelet@mail.ap-hm.fr

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

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/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15987398

Publication citations

  1. Results

    Michelet P, Roch A, Gainnier M, Sainty JM, Auffray JP, Papazian L, Influence of support on intra-abdominal pressure, hepatic kinetics of indocyanine green and extravascular lung water during prone positioning in patients with ARDS: a randomized crossover study., Crit Care, 2005, 9, 3, R251-7, doi: 10.1186/cc3513.

Additional files

Editorial Notes