Ignite Creation Date:
2024-05-06 @ 8:57 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02866578
Status:
COMPLETED
Last Update Posted:
2023-03-20
First Post:
2016-07-07
Brief Title:
Open Lung Protective Ventilation in Cardiac Surgery
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Open Lung Protective Ventilation During Cardiac Surgery With Cardiopulmonary Bypass a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2016-12
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:
PROVECS
Brief Summary:
Cardiac surgery with cardiopulmonary bypass CPB frequently induces post-operative respiratory dysfunction The post-operative pulmonary complications PPCs significantly increase the peri-operative morbidity and require invasive treatments during longer and more expensive ICU stays A specific pathophysiology involving general anesthesia and CPB-related factors inflammation pulmonary ischemia has been clearly demonstrated and pulmonary atelectasis seems to play a central role in the occurence of these PPCs The open lung approach is a ventilation strategy that aims to open the lung and keep it open using different ventilatory settings The efficacy of that strategy is not demonstrated in the global surgical population However its application in the perioperative care of cardiac surgery patients could be of great interest by counteracting the development of atelectasis
The purpose of this multicentre double blinded randomized controlled study is to evaluate the influence of a perioperative multimodal protective ventilation strategy based on the open lung approach on postoperative outcomes during the first 7 days following cardiac surgery Participating centres will include 500 adult patients undergoing scheduled on-pump cardiac surgery The open lung approach will combine recruitment maneuvers RM positive end expiratory pressure PEEP at 8 cmH2O from intubation to detubation and continuation of ultraprotective ventilation during CPB It will be compared to a conventional approach without RM with PEEP at 2 cmH2O and discontinuation of ventilation during CPB The primary endpoint is any post-operative pulmonary complication The secondary endpoints are any post-operative extra-pulmonary complications and the number of ICU-free days to day 7
The purpose of this multicentre double blinded randomized controlled study is to evaluate the influence of a perioperative multimodal protective ventilation strategy based on the open lung approach on postoperative outcomes during the first 7 days following cardiac surgery Participating centres will include 500 adult patients undergoing scheduled on-pump cardiac surgery The open lung approach will combine recruitment maneuvers RM positive end expiratory pressure PEEP at 8 cmH2O from intubation to detubation and continuation of ultraprotective ventilation during CPB It will be compared to a conventional approach without RM with PEEP at 2 cmH2O and discontinuation of ventilation during CPB The primary endpoint is any post-operative pulmonary complication The secondary endpoints are any post-operative extra-pulmonary complications and the number of ICU-free days to day 7
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-A00352-49 | OTHER | IDRCB | None |