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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00352-49 | Other Identifier | IDRCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open lung protective ventilation | Experimental |
|
|
| Conventional strategy | No Intervention | No recruitment maneuvers. PEEP at 2 cmH2O. During CPB: continuous positive pressure at 2 cmH2O. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open lung protective ventilation strategy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pulmonary complications defined as a composite endpoint | Mild hypoxemia Moderate hypoxemia Severe hypoxemia Severe bronchospam Radiological atelectasis Respiratory acidosis Pneumonia Pleural effusion Acute Respiratory Distress Syndrome Need for reintubation Need for reintubation | first 7 days post-operatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative extrapulmonary complication | Systemic inflammatory response syndrome Sepsis Septic chock Mediastinitis Pericardial tamponade Surgical bleeding Acute kidney failure (KDIGO stage 2 or 3) Postoperative atrial fibrillation Cardiogenic chock Delirium | First 7 days post operatively |
| ICU free Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Urielle DESALBRES | AP-HM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | France | ||||
| Hôpital Louis Pradel HCL |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31576435 | Derived | Lagier D, Fischer F, Fornier W, Huynh TM, Cholley B, Guinard B, Heger B, Quintana G, Villacorta J, Gaillat F, Gomert R, Degirmenci S, Colson P, Lalande M, Benkouiten S, Minh TH, Pozzi M, Collart F, Latremouille C, Vidal Melo MF, Velly LJ, Jaber S, Fellahi JL, Baumstarck K, Guidon C; PROVECS Study Group. Effect of open-lung vs conventional perioperative ventilation strategies on postoperative pulmonary complications after on-pump cardiac surgery: the PROVECS randomized clinical trial. Intensive Care Med. 2019 Oct;45(10):1401-1412. doi: 10.1007/s00134-019-05741-8. Epub 2019 Oct 1. | |
| 30424770 |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Days alive and free from the need of intensive care |
| First 7 days post operatively |
| Lyon |
| France |
| Assistance Publique Hopitaux de Marseille | Marseille | 13354 | France |
| CHU MontpellierHôpital Arnaud de VILLENEUVE | Montpellier | France |
| Hôpital Européen Georges Pompidou AP-HP | Paris | France |
| CHU Strasbourg | Strasbourg | France |
| Derived |
| Lagier D, Fischer F, Fornier W, Fellahi JL, Colson P, Cholley B, Jaber S, Baumstarck K, Guidon C; PROVECS investigators and the ARCOTHOVA group. A perioperative surgeon-controlled open-lung approach versus conventional protective ventilation with low positive end-expiratory pressure in cardiac surgery with cardiopulmonary bypass (PROVECS): study protocol for a randomized controlled trial. Trials. 2018 Nov 13;19(1):624. doi: 10.1186/s13063-018-2967-y. |