Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263146
Status:
TERMINATED
Last Update Posted:
2017-01-16
First Post:
2005-12-05
Brief Title:
Recruitment Maneuvers in ARDS Effects on Respiratory Function and Inflammatory Markers
Sponsor:
University Hospital Tours
Organization:
University Hospital Tours
Study Overview
Official Title:
Recruitment Maneuvers in ARDS Effects on Respiratory Function and Inflammatory ARAMIS Apport dun Recrutement Alveolaire Sur Les Marqueurs de lInflammation Dans le SDRA
Status:
TERMINATED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of inclusion due to changed medical practice
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute Respiratory Distress Syndrom is associated to lung and systemic inflammation which could be worsened by mechanical ventilationThis included a proteasis - antiproteasis imbalance which could participate to a fibrosis process
Low tidal-volume ventilation 6 mLkg with low plateau pressure 30 cm H2O has been proved to decrease mortality when compared with more conventionnal high-volume 12 mLkg ventilationMoreover this lung-protective approach decrease lung annd systemic inflammation
Using recruitment maneuvers ie the application during a short time of high pressures with the intention to re-open the lung followed by an increase of PEEP-level to keep the lung open in an attempt to decrease the alveolar shear-stress has been proposed to improve oxygen and to reduce bio-trauma
However the effect of such maneuvers on the inflammatory response and on the evolution of ARDS remains unknown
Therefore we have planned a randomized monocentric controlled trial consisting of the comparison of two approaches of mechanical ventilation in Acute Lung Injury This trial will include 30 hemodynamically stable patients fulfilling the ALI or ARDS criteria defined by the US and European Consensus Conference
They will be randomized in two groups standard low-volume ventilation vs recruitment maneuvers
The main objective of our study is to compare both ventilatory strategies in termes of lung and systemic inflammation
The primary outcome measures will be the proteasis activity as measured in broncho alveolar fluid BAL and pro- and antiinflammatory cytokines activity as measured in the BAL and in the blood Two samples BAL and blood will be obtained at a 48-72 hours interval In the recruitment maneuver group the first BAL will be obtained two hours before the maneuver
Secondary outcome measures will be gaz exchange respiratory mechanics systemic hemodynamics and visceral dysfunction scores
Low tidal-volume ventilation 6 mLkg with low plateau pressure 30 cm H2O has been proved to decrease mortality when compared with more conventionnal high-volume 12 mLkg ventilationMoreover this lung-protective approach decrease lung annd systemic inflammation
Using recruitment maneuvers ie the application during a short time of high pressures with the intention to re-open the lung followed by an increase of PEEP-level to keep the lung open in an attempt to decrease the alveolar shear-stress has been proposed to improve oxygen and to reduce bio-trauma
However the effect of such maneuvers on the inflammatory response and on the evolution of ARDS remains unknown
Therefore we have planned a randomized monocentric controlled trial consisting of the comparison of two approaches of mechanical ventilation in Acute Lung Injury This trial will include 30 hemodynamically stable patients fulfilling the ALI or ARDS criteria defined by the US and European Consensus Conference
They will be randomized in two groups standard low-volume ventilation vs recruitment maneuvers
The main objective of our study is to compare both ventilatory strategies in termes of lung and systemic inflammation
The primary outcome measures will be the proteasis activity as measured in broncho alveolar fluid BAL and pro- and antiinflammatory cytokines activity as measured in the BAL and in the blood Two samples BAL and blood will be obtained at a 48-72 hours interval In the recruitment maneuver group the first BAL will be obtained two hours before the maneuver
Secondary outcome measures will be gaz exchange respiratory mechanics systemic hemodynamics and visceral dysfunction scores
Detailed Description:
None
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