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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN67999735 |
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Date of registration:
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26/04/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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Date of first enrolment:
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01/01/2003 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN67999735 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Quality of life)
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Phase:
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Countries of recruitment
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France
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Pierre
Michelet |
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Address:
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Département d'Anesthésie Réanimation
Sainte Marguerite Hospital
13009
Marseille
France |
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Telephone:
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Email:
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pierre.michelet@mail.ap-hm.fr |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
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.
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Acute Respiratory Distress Syndrome (ARDS)
Respiratory
Respiratory disorders
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Intervention(s)
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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.
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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No secondary outcome measures
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Source(s) of Monetary Support
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Not provided at time of registration
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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