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Sponsored by: |
Hospices Civils de Lyon |
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Information provided by: | Hospices Civils de Lyon |
ClinicalTrials.gov Identifier: | NCT00527813 |
We project to test the effect of prone position on mortality in severe ARDS patients (PaO2/FiO2<150 with FiO2 0.6 and positive end-expiratory pressure 5 cmH2O). Ventilator will be set in accordance with current standards aming at protecting the lungs from VALI. Patients will be randomized into two arms: prone group in which proning will be realised for at least 16 hours a day and supine group in which patients will stay in a semi-recumbent position. Primary end-point is 28-day mortality of all causes. Secondary end-points are 90-day mortality of all causes and incidence of ventilator-acquired pneumonia. Study sample was calculated to detect ability of proning to reduce mortality from 60 to 45% percent, at one-tailed error of 5% and power of 90% and 230 patients are needed in each arm.
Condition | Intervention |
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Acute Respiratory Distress Syndrome |
Procedure: prone position |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Effect of Prone Positionning on Mortality in Patients With Severe and Persistent Acute Respiratory Distress Syndrome |
Estimated Enrollment: | 460 |
Study Start Date: | September 2007 |
Arms | Assigned Interventions |
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A: Experimental
prone position for at least 16 hours per day
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Procedure: prone position
prone position for at least 16 hours per day
|
B: No Intervention
semi-recumbent position
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The acute respiratory distress syndrome (ARDS) is an acute respiratory failure characterized by bilateral pulmonary infiltrates on frontal chest radiography, arterial oxygen tension (Pao2) to fraction of inspired oxygen (FiO2) ratio of 200 or less, and absence of evidence for left atrial hypertension. In-hospital mortality remains high: from 40 to 60%. Typical pathological findings include disruption of the alveolar epithelium, diffuse alveolar damage, hyaline membranes and pulmonary inflammation. Gas exchange is severely altered making of invasive mechanical ventilation required in most of the cases. Mechanical ventilation should be judiciously set in order to protect the lung from ventilator- associated lung injury (VALI). VALI is commonly seen as the expression of two main alveolar strains. The well documented one to date is overdistension of alveoli when high tidal volumes are used. A North-American randomised controlled trial (RCT) has demonstrated that using low tidal volumes (6 ml per kilo of predicted weight) results in a 22% decrease in mortality when compared with high tidal volumes (12 ml per kilo of predicted weight). As suggested by an ancillary study of this trial, a reduced pulmonary inflammation is one of the contributing factors of this result. Therefore, minimizing VALI is a primary therapeutic goal. Low lung volume VALI is the second potential mechanism, though less well documented. It is expected to result from repetitive collapse and reopening of terminal respiratory units. Experimental data suggest that proning can reduce VALI by homogenizing lung strains. In ARDS patients, proning is mainly used due to its ability to improve gas exchange in 60 to 70% of patients. Nonetheless, 3 RCTs failed to demonstrate a significant effect on mortality of proning in three clinical situations: 1: acute lung injury, 2: hypoxemic acute respiratory failure, 3: ARDS. Post hoc analysis of one of them has suggested an effect of proning on mortality for the most hypoxemic sub-group. Studies limitations can explain lack of statistical significance as lack of power, heterogeneity of patients, insufficient duration of proning, high tidal volumes. Only one RCT was specifically designed for ARDS. Mortality was 25% lowest in the prone position arm, but this difference was not significant due to lack of power. So, the capability of proning to improve patient survival in ARDS is still an open question.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Presenting with a Severe ARDS :
Exclusion Criteria:
contra-indication to the prone position
Exclusion criteria for respiratory raisons
Exclusion criteria linked to clinical context
Other exclusion criteria
Contact: Guerin Claude, MD | 33 472 071 762 | claude.guerin@chu-lyon.fr |
France | |
Hôpital Croix Rousse | |
Lyon, France, 69317 |
Principal Investigator: | Guerin Claude, MD | Hospices Civils de Lyon |
Study ID Numbers: | 2007.474 |
Study First Received: | September 10, 2007 |
Last Updated: | September 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00527813 History of Changes |
Health Authority: | France:Comité de protection des personnes Sud Est IV |
acute respiratory distress syndrome prone position Acute respiratory distress syndrome (ARDS) |
Respiratory Tract Diseases Lung Diseases Respiration Disorders Respiratory Distress Syndrome, Adult Acute Respiratory Distress Syndrome |
Pathologic Processes Disease Respiratory Tract Diseases Lung Diseases |
Syndrome Respiration Disorders Respiratory Distress Syndrome, Adult |