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
Scientific
Département d'Anesthésie Réanimation
Sainte Marguerite Hospital
Marseille
13009
France
pierre.michelet@mail.ap-hm.fr |
Study information
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 |
Scientific title | |
Study objectives | 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. |
Health condition(s) or problem(s) studied | 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 |
Completion date | 01/01/2004 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 20 |
Key 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. |
Key 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. |
Date of first enrolment | 01/01/2003 |
Date of final enrolment | 01/01/2004 |
Locations
Countries of recruitment
- France
Study participating centre
Département d'Anesthésie Réanimation
Marseille
13009
France
13009
France
Sponsor information
Sainte Marguerite Hospital (France)
Hospital/treatment centre
Hospital/treatment centre
-
Marseille
13009
France
pierre.michelet@mail.ap-hm.fr | |
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |