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NCT Number: NCT07024420

Sigh Ventilation in Cardiac Surgery

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.

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Key information

Conditions

Postoperative Pulmonary Complications (PPCs) Cardiac Surgery in Adult Patient

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Location status: Recruiting

Location contact

Fengmei Guo, Ph.D, M.D

PRINCIPAL_INVESTIGATOR

Zhichang Wang, M.D.

CONTACT

[email protected]

+8615261887038

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sigh Breaths

Other

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.

Low Tidal Volume

Other

6-8ml/kg predicted body weight

Moderate PEEP

Other

PEEP set according to ARDSnet low PEEP- fraction of inspired oxygen table, FiO2 was set as the lowest fraction targeted to maintain SpO2 ≥ 96%

Primary outcomes

  1. Proportion of major postoperative pulmonary complications (Grade ≥ 3 ) through POD7

    Time frame: From randomization to postoperative day 7

    Postoperative pulmonary complications were scored using a grade scale ranging from 0 to 5. Major postoperative pulmonary complications are defined as Grade ≥ 3.

    Grade 3 (Pleural effusion, pneumonia, pneumothorax, HFNC OR NIV support, re-intubation), Grade 4 (IMV dependence ≥ 48h, HFNC OR NIV dependence ≥ 48h ), Grade 5 (Death).

Secondary outcomes

  1. Severity of postoperative pulmonary complications through POD7

    Time frame: From randomization to postoperative day 7

    Postoperative pulmonary complications were scored using a grade scale ranging from 0 to 5. Using the worst score within POD7 for analysis.

    Grade 0 (No symptom of interest), Grade 1 (Dry cough, microatelectasis, dyspnea), Grade 2 (Productive cough, bronchospasm, hypoxemia, atelectasis, hypercarbia), Grade 3 (Pleural effusion, pneumonia, pneumothorax, HFNC OR NIV support, re-intubation), Grade 4 (IMV dependence ≥ 48h, HFNC OR NIV dependence ≥ 48h ), Grade 5 (Death).

  2. Proportion of major postoperative pulmonary complications (Grade ≥ 3 ) through hospitalization

    Time frame: From randomization up to hospital discharge, assessed up to postoperative day 30

    Postoperative pulmonary complications were scored using a grade scale ranging from 0 to 5. Major postoperative pulmonary complications are defined as Grade ≥ 3.

    Grade 3 (Pleural effusion, pneumonia, pneumothorax, HFNC OR NIV support, re-intubation), Grade 4 (IMV dependence ≥ 48h, HFNC OR NIV dependence ≥ 48h ), Grade 5 (Death).

  3. Severity of postoperative pulmonary complications through hospitalization

    Time frame: From randomization up to hospital discharge, assessed up to postoperative day 30

    Postoperative pulmonary complications were scored using a grade scale ranging from 0 to 5. Using the worst score within hospitalization for analysis.

    Grade 0 (No symptom of interest), Grade 1 (Dry cough, microatelectasis, dyspnea), Grade 2 (Productive cough, bronchospasm, hypoxemia, atelectasis, hypercarbia), Grade 3 (Pleural effusion, pneumonia, pneumothorax, HFNC OR NIV support, re-intubation), Grade 4 (IMV dependence ≥ 48h, HFNC OR NIV dependence ≥ 48h ), Grade 5 (Death).

  4. No Ventilatory Support Days by POD7

    Time frame: From randomization to postoperative day 7

    Days alive and not receive IMV, HFNC, and NIV support

  5. No Ventilatory Support Days by POD30

    Time frame: From randomization to postoperative day 30

    Days alive and not receive IMV, HFNC, and NIV support

  6. Proportion of Acute Respiratory Distress Syndrome through hospitalization

    Time frame: From randomization up to hospital discharge, assessed up to postoperative day 30

    ARDS diagnosed according to the 2023 ATS New Global Definition

  7. Intensive Care Unit length of stay by POD30

    Time frame: From randomization to postoperative day 30

  8. Hospital length of stay by POD30

    Time frame: From randomization to postoperative day 30

  9. 30-day mortality

    Time frame: From randomization to postoperative day 30

    The proportion of patients who died within postoperative day 30

Other outcomes

  1. Shock-free days

    Time frame: From randomization to postoperative day 30

    Shock was defined as receiving any intravenous infusion of vasopressor/inotropic (i.e. norepinephrine, epinephrine, phenylephrine, vasopressin analogues, angiotensin, dopamine, dobutamine, milrinone or levosimendan), and patients transferred out of the ICU were assumed to be shock free. A value of 0 free days for patients who died before POD30.

  2. Barotrauma

    Time frame: From randomization up to hospital discharge, assessed up to postoperative day 30

    Barotrauma includes pneumothorax, pneumomediastinum, or subcutaneous emphysema.

  3. Pneumothorax

    Time frame: From randomization up to hospital discharge, assessed up to postoperative day 30

    Pneumothorax detected through chest X-ray or CT scan

  4. New-onset atrial fibrillation

    Time frame: From randomization to hospital discharge, assessed up to postoperative day 30

    New-onset atrial fibrillation detected through ECG

  5. Ventricular fibrillation

    Time frame: From randomization to hospital discharge, assessed up to postoperative day 30

    Ventricular fibrillation detected through ECG

  6. Cardiac arrest

    Time frame: From randomization to hospital discharge, assessed up to postoperative day 30

    The proportion of patients with cardiac arrest

  7. Other adverse events

    Time frame: From randomization to hospital discharge, assessed up to postoperative day 30

    The proportion of other adverse events related to the interventions assessed by investigators

Study contacts

Contact information is provided by the study sponsor or research team.

Zhichang Wang

CONTACT

[email protected]

+8618255127433

Sponsors and collaborators

Lead sponsor

Zhongda Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 17, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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