Clinical trial NCT07024420: Sigh Ventilation in Cardiac Surgery
Official title: Effect of Sigh Ventilation on Postoperative Pulmonary Complications in Cardiac Surgery: A Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Pulmonary Complications (PPCs)
Cardiac Surgery in Adult Patient
Keywords: Sigh Ventilation
Cardiac Surgery
Postoperative Pulmonary Complications
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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 recruitment maneuvers, 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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older;
* Elective cardiac surgery requiring cardiopulmonary bypass;
* Written informed consent is obtained from patients and/or their legal representatives.

Exclusion Criteria:

* Emergence surgery;
* Left ventricular assist device implantation;
* 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.

Primary outcomes:
measure: Proportion of major postoperative pulmonary complications (Grade ≥ 3 ) through POD7
timeFrame: within the first 7 postoperative days
Secondary outcomes:
measure: Severity of postoperative pulmonary complications through POD7
timeFrame: within the first 7 postoperative days
measure: Proportion of major postoperative pulmonary complications (Grade ≥ 3 ) through hospitalization
timeFrame: From randomization up to hospital discharge, maximum censoring at postoperative day 30
measure: Severity of postoperative pulmonary complications through hospitalization
timeFrame: From randomization up to hospital discharge, maximum censoring at postoperative day 30
measure: No Ventilatory Support Days by POD7
timeFrame: by the postoperative day 7
measure: No Ventilatory Support Days by POD30
timeFrame: by the postoperative day 30
measure: Proportion of Acute Respiratory Distress Syndrome through hospitalization
timeFrame: From randomization up to hospital discharge, maximum censoring at postoperative day 30
measure: Intensive Care Unit length of stay by POD30
timeFrame: by the postoperative day 30
measure: Hospital length of stay by POD30
timeFrame: by the postoperative day 30
measure: Mortality within 30 days
timeFrame: Postoperative day 30
measure: Shock-free days by POD30
timeFrame: by the postoperative day 30
measure: Proportion of barotrauma through hospitalization
timeFrame: From randomization up to hospital discharge, maximum censoring at postoperative day 30
measure: Proportion of pneumothorax through hospitalization
timeFrame: From randomization up to hospital discharge, maximum censoring at postoperative day 30
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital, Southeast University
state: Jiangsu
Study officials:
References:
citation: 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.
citation: 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.