Open Lung Protective Ventilation in Cardiac Surgery

NCT02866578 | Completed

• 2 other identifiers: 2016-032016-A00352-49
• Study Type: interventional
• Target: 494
• Locations: 1 country
• Sites: 6

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.

Conditions

Hypoxemia

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• Postoperative extrapulmonary complication

  First 7 days post operatively

• ICU free Days

  First 7 days post operatively

Study Arms (2)

Open lung protective ventilation

EXPERIMENTAL

* Recruitment maneuvers (30 cmH2O during 30 seconds) after intubation, after CPB initiation, before aortic declamping and at ICU arrival. * PEEP at 8 cmH2O. * Ultraprotective ventilation during CPB: PEEP 8 cmH2O, Tidal volume 3mL/kg, Respiratory rate 12 cycles per minute, FiO2 40%. * Assigned intervention - Procedure: patients are randomized and ventilated with the open lung strategy from intubation to detubation.

Procedure: Open lung protective ventilation strategy

Conventional strategy

NO INTERVENTION

No recruitment maneuvers. PEEP at 2 cmH2O. During CPB: continuous positive pressure at 2 cmH2O.

Interventions

Open lung protective ventilation strategy PROCEDURE

Open lung protective ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cardiac surgery planned with CPB and sternotomy.
• Age \> 18 years old.

You may not qualify if:

• Urgent surgery : cardiac transplantation, aortic dissection, active endocarditis.
• Aortic arch surgery with circulatory arrest.
• LVAD surgery.
• Acute or chronic preoperative hypoxemia (PaO2 \< 65 mmHg in air).
• Preoperative shock state requiring catecholamines.
• LVEF \< 40%.
• Pulmonary hypertension with systolic pulmonary artery pressure \> 50 mmHg.
• Severe right ventricular dysfunction (TDI tricuspid annular systolic velocity \< 10 cm.s-1).
• Chronic kidney disease (Glomerular filtration rate \< 30 mL/min).
• Body Mass Index \> 35kg/m2.
• Patient's refusal.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (6)

CHU de Bordeaux

Bordeaux, France

Location

Hôpital Louis Pradel HCL

Lyon, France

Location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

CHU MontpellierHôpital Arnaud de VILLENEUVE

Montpellier, France

Location

Hôpital Européen Georges Pompidou AP-HP

Paris, France

Location

CHU Strasbourg

Strasbourg, France

Location

Related Publications (2)

• 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.

  PMID: 31576435 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.

  PMID: 30424770 DERIVED

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Urielle DESALBRES

  AP-HM

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: August 15, 2016
• Study Start: September 23, 2016
• Primary Completion: May 7, 2018
• Study Completion: May 7, 2018
• Last Updated: March 20, 2023

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)