Influence of support on intra-abdominal pressure, hepatic kinetics of indocyanine green and extravascular lung water during Prone Positioning (PP) in ARDS patients: a randomised crossover study

ISRCTN ISRCTN67999735
DOI https://doi.org/10.1186/ISRCTN67999735
Secondary identifying numbers N/A
Submission date
26/04/2005
Registration date
26/04/2005
Last edited
27/07/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Pierre Michelet
Scientific

Département d'Anesthésie Réanimation
Sainte Marguerite Hospital
Marseille
13009
France

Email pierre.michelet@mail.ap-hm.fr

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Scientific title
Study objectivesThe 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.
Health condition(s) or problem(s) studiedAcute Respiratory Distress Syndrome (ARDS)
InterventionBaseline 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 typeOther
Primary outcome measure1. 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 measuresNo secondary outcome measures
Overall study start date01/01/2003
Completion date01/01/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants20
Key inclusion criteriaTwenty 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.
Key exclusion criteriaPatients 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.
Date of first enrolment01/01/2003
Date of final enrolment01/01/2004

Locations

Countries of recruitment

  • France

Study participating centre

Département d'Anesthésie Réanimation
Marseille
13009
France

Sponsor information

Sainte Marguerite Hospital (France)
Hospital/treatment centre

-
Marseille
13009
France

Email pierre.michelet@mail.ap-hm.fr
ROR logo "ROR" https://ror.org/0338wkj94

Funders

Funder type

Not defined

Not provided at time of registration

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/06/2005 Yes No