Sigh Ventilation in Cardiac Surgery

Official title

Effect of Sigh Ventilation on Postoperative Pulmonary Complications in Cardiac Surgery: A Multicenter, Randomized Controlled Trial

Overview

The purpose of this trial is to investigate whether sigh ventilation strategy, combining sigh breaths, low tidal volume, and moderate PEEP levels, protects against major pulmonary complications within the first 7 postoperative days after cardiac surgery, as compared with conventional ventilation strategy with low tidal volume, and moderate PEEP levels.

Detailed description

Preventing postoperative pulmonary complications with the use of low tidal volume ventilation is now an established consensus. However, low tidal volume promote alveolar collapse in poorly ventilated, dependent regions of the lung.

Recruitment maneuvers, typically delivered at specific intraoperative timepoints, aimed to counteract alveolar collapse promoted by low tidal volume, was found to yield transient physiological benefits. And the PROVECS trial failed to show extra benefit of recruitment maneuvers in cardiac surgery patients in terms of pulmonary complications within the first 7 postoperative days, as compared with low tidal volume ventilation.

Sigh breaths, which involves cyclic deep inflations to re-expand alveoli, potentially providing sustained benefits. The purpose of this trial is to investigate the specific role of sigh breaths for reducing pulmonary complications in cardiac surgery patients already receiving protective ventilation with low tidal volume and moderate PEEP levels.

Interventions

• Other Sigh Breaths
  Sigh breaths were added by elevating PEEP, targeting a plateau pressure of 35 cmH2O (or 40 cmH2O for patients with a Body Mass Index \> 35 kg/m2). These sigh breaths were administered once every 6 minutes at predefined stages in the perioperative period from the time of anesthesia intubation until endotracheal extubation, postoperative day 7, or death, whichever occurred first, but not during transport. Each sigh consisted of the minimum number of respiratory cycles aimed to achieve a total dura
• Other Low Tidal Volume
  6-8ml/kg predicted body weight
• Other Moderate PEEP
  PEEP set according to ARDSnet low PEEP- fraction of inspired oxygen table, FiO2 was set as the lowest fraction targeted to maintain SpO2 ≥ 96%

Primary outcome measures

• Proportion of major postoperative pulmonary complications (Grade ≥ 3 ) through POD7 [Time frame: From randomization to postoperative day 7]

Secondary outcome measures (9)

• Severity of postoperative pulmonary complications through POD7 [Time frame: From randomization to postoperative day 7]
• Proportion of major postoperative pulmonary complications (Grade ≥ 3 ) through hospitalization [Time frame: From randomization up to hospital discharge, assessed up to postoperative day 30]
• Severity of postoperative pulmonary complications through hospitalization [Time frame: From randomization up to hospital discharge, assessed up to postoperative day 30]
• No Ventilatory Support Days by POD7 [Time frame: From randomization to postoperative day 7]
• No Ventilatory Support Days by POD30 [Time frame: From randomization to postoperative day 30]
• Proportion of Acute Respiratory Distress Syndrome through hospitalization [Time frame: From randomization up to hospital discharge, assessed up to postoperative day 30]
• Intensive Care Unit length of stay by POD30 [Time frame: From randomization to postoperative day 30]
• Hospital length of stay by POD30 [Time frame: From randomization to postoperative day 30]
• 30-day mortality [Time frame: From randomization to postoperative day 30]

Eligibility criteria

Inclusion criteria

• 18 years of age or older;
• Elective cardiac surgery with cardiopulmonary bypass, aortic clamp and cardioplegia;
• Written informed consent is obtained from patients and/or their legal representatives.

Exclusion criteria

• Emergence surgery;
• Left ventricular assist device implantation;
• Planned thoracotomy with one lung ventilation;
• Undergo concurrent surgical procedures outside cardiology;
• Neuromuscular illness;
• Mechanical ventilation within the last 2 weeks before surgery, include CPAP and NIV;
• Preoperative shock;
• Preoperative Hypoxemia (PaO2<60mmHg OR SpO2<90% on ambient air);
• Preoperative left ventricular ejection fraction < 40%;
• Systolic pulmonary artery pressure > 50 mmHg.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

China · 1 center

• Zhongda Hospital, Southeast University — Nanjing

Publications

• Lagier D, Velly LJ, Guinard B, Bruder N, Guidon C, Vidal Melo MF, Alessi MC. Perioperative Open-lung Approach, Regional Ventilation, and Lung Injury in Cardiac Surgery. Anesthesiology. 2020 Nov 1;133(5):1029-1045. doi: 10.1097/ALN.0000000000003539. PMID 32902561
• 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 pulmo PMID 31576435

Identifiers

NCT: NCT07024420 · SIVECS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗