RecruitingNot ApplicableNCT07024420

Sigh Ventilation in Cardiac Surgery

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

Sponsor

Zhongda Hospital

Enrollment

686 participants

Start Date

Oct 9, 2025

Study Type

INTERVENTIONAL

Conditions

Postoperative Pulmonary Complications (PPCs)Cardiac Surgery in Adult Patient

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 low tidal volume, and moderate PEEP levels.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria10

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.

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Interventions

OTHERSigh 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 duration of at least 5 seconds, based on the respiratory cycle duration preset on the ventilator.

OTHERLow Tidal Volume

6-8ml/kg predicted body weight

OTHERModerate 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%