Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study 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
Primary outcome measure
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 study start date
01/01/2003
Overall study end date
01/01/2004
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Not Specified
Sex
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
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/06/2005 | Yes | No |