Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00527813
Status:
COMPLETED
Last Update Posted:
2015-05-07
First Post:
2007-09-10
Brief Title:
Effect of Prone Positioning on Mortality in Patients With Severe and Persistent Acute Respiratory Distress Syndrome
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Effect of Prone Positioning on Mortality in Patients With Severe and Persistent Acute Respiratory Distress Syndrome
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Proseva
Brief Summary:
We project to test the effect of prone position on mortality in severe ARDS patients PaO2FiO2150 with FiO2 or 06 and positive end-expiratory pressure or 5 cmH2O Ventilator will be set in accordance with current standards aiming at protecting the lungs from VALI Patients will be randomized into two arms prone group in which proning will be realized 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 alpha error of 5 and power of 90 and 230 patients are needed in each arm
Detailed Description:
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 over distension of alveoli when high tidal volumes are used A North-American randomized 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None