Sigh Ventilation in Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

686 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-09

Study Completion Date

2027-12-31

Brief Summary

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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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Detailed Description

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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

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Postoperative Pulmonary Complications (PPCs) Cardiac Surgery in Adult Patient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sigh Ventilation

sigh breaths, low tidal volume and moderate PEEP levels

Group Type EXPERIMENTAL

Sigh Breaths

Intervention Type 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

Intervention Type OTHER

6-8ml/kg predicted body weight

Moderate PEEP

Intervention Type 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%

Conventional Ventilation

low tidal volume, moderate PEEP levels

Group Type ACTIVE_COMPARATOR

Low Tidal Volume

Intervention Type OTHER

6-8ml/kg predicted body weight

Moderate PEEP

Intervention Type 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%

Interventions

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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.

Intervention Type OTHER

Low Tidal Volume

6-8ml/kg predicted body weight

Intervention Type 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%

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No