NCT07024420

Sigh Ventilation in Cardiac Surgery

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 686 (estimated)
• Sponsor: Zhongda Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Postoperative Pulmonary Complications (PPCs)
• Cardiac Surgery in Adult Patient

Interventions

Type	Name	Description
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 duration of at least 5 seconds, based on the respiratory cycle duration preset on the ventilator.
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%

Timeline

• Start date: 2025-10-09
• Primary completion: 2027-11-30
• Completion: 2027-12-31
• First posted: 2025-06-17
• Last updated: 2025-11-18

Locations

1 site across 1 country: China