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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Zhongda Hospital, Southeast University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Zhichang Wang
• Email: wang15zc@163.com
• Phone: +8618255127433

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.