Adding periodic 'sigh' breaths to lung-protective ventilation during heart surgery

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

This trial will test whether adding periodic deep 'sigh' breaths to low tidal volume, moderate PEEP ventilation reduces early lung complications in adults having elective cardiac surgery with cardiopulmonary bypass.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 686 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhongda Hospital (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07024420 on ClinicalTrials.gov

What this trial studies

Adults having elective cardiac surgery with cardiopulmonary bypass are assigned to receive either a ventilation strategy that includes cyclic deep 'sigh' breaths combined with low tidal volumes and moderate PEEP or a conventional protective strategy using low tidal volumes and moderate PEEP alone. The intervention is delivered intraoperatively around established timepoints for lung expansion. The main outcome is occurrence of major postoperative pulmonary complications during the first seven days after surgery. The protocol excludes patients with preoperative hypoxemia, severe left ventricular dysfunction, recent mechanical ventilation, or procedures requiring one-lung ventilation.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) scheduled for elective cardiac surgery with cardiopulmonary bypass, aortic clamp, and cardioplegia who can provide informed consent and do not meet exclusion criteria.

Not a fit: Patients having emergency surgery, left ventricular assist device implantation, planned thoracotomy/one-lung ventilation, recent mechanical ventilation, preoperative shock or hypoxemia, severe LV dysfunction (EF <40%), or very high pulmonary artery pressure are excluded and unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the approach could lower the rate of early postoperative pulmonary complications and may shorten ICU or hospital recovery after cardiac surgery.

How similar studies have performed: Previous work established low tidal volume ventilation as protective, while the PROVECS trial found no extra benefit from recruitment maneuvers in cardiac surgery, and the specific use of cyclic 'sigh' breaths remains less tested.

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.

Where this trial is running

Nanjing, Jiangsu

• Zhongda Hospital, Southeast University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Zhichang Wang

Conditions Postoperative Pulmonary Complications; Cardiac Surgery in Adult Patient; Sigh Ventilation; Cardiac Surgery