Sigh Ventilation in Cardiac Surgery

Southeast University

Status: Not yet enrolling

Conditions: Postoperative Pulmonary Complications (PPCs); Cardiac Surgery in Adult Patient

Treatments: Other: Low Tidal Volume; Other: Moderate PEEP; Other: Sigh Breaths; Other: Recruitment maneuvers

Study type: Interventional

Funder types: Other

Identifiers

NCT07024420

SIVECS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 372 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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372 participants in 2 patient groups

Sigh Ventilation

Experimental group

Description:

sigh breaths, low tidal volume and moderate PEEP levels

Treatment:

Other: Sigh Breaths

Other: Moderate PEEP

Other: Low Tidal Volume

Conventional Ventilation

Active Comparator group

Description:

low tidal volume, moderate PEEP levels, and recruitment maneuvers

Treatment:

Other: Recruitment maneuvers

Other: Moderate PEEP

Other: Low Tidal Volume