Sigh Ventilation in Cardiac Surgery

NCT07024420 | Recruiting DMC

• 1 other identifier: SIVECS
• Study Type: interventional
• Target: 686
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Sigh Ventilation; Cardiac Surgery; Postoperative Pulmonary Complications

Outcome Measures

Primary Outcomes (1)

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

  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).

  From randomization to postoperative day 7

Secondary Outcomes (9)

• Severity of postoperative pulmonary complications through POD7

  From randomization to postoperative day 7

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

  From randomization up to hospital discharge, assessed up to postoperative day 30

• Severity of postoperative pulmonary complications through hospitalization

  From randomization up to hospital discharge, assessed up to postoperative day 30

• No Ventilatory Support Days by POD7

  From randomization to postoperative day 7

• No Ventilatory Support Days by POD30

  From randomization to postoperative day 30

Other Outcomes (7)

• Shock-free days

  From randomization to postoperative day 30

• Barotrauma

  From randomization up to hospital discharge, assessed up to postoperative day 30

• Pneumothorax

  From randomization up to hospital discharge, assessed up to postoperative day 30

Study Arms (2)

Sigh Ventilation

EXPERIMENTAL

sigh breaths, low tidal volume and moderate PEEP levels

Other: Sigh Breaths; Other: Low Tidal Volume; Other: Moderate PEEP

Conventional Ventilation

ACTIVE COMPARATOR

low tidal volume, moderate PEEP levels

Other: Low Tidal Volume; Other: Moderate PEEP

Interventions

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.

Sigh Ventilation

Low Tidal Volume OTHER

6-8ml/kg predicted body weight

Conventional Ventilation; Sigh Ventilation

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%

Conventional Ventilation; Sigh Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

Related Publications (2)

• Lagier D, Velly LJ, Guinard B, Bruder N, Guidon C, Vidal Melo MF, Alessi MC. Perioperative Open-lung Approach, Regional Ventilation, and Lung Injury in Cardiac Surgery. Anesthesiology. 2020 Nov 1;133(5):1029-1045. doi: 10.1097/ALN.0000000000003539.

  PMID: 32902561 RESULT

• Lagier D, Fischer F, Fornier W, Huynh TM, Cholley B, Guinard B, Heger B, Quintana G, Villacorta J, Gaillat F, Gomert R, Degirmenci S, Colson P, Lalande M, Benkouiten S, Minh TH, Pozzi M, Collart F, Latremouille C, Vidal Melo MF, Velly LJ, Jaber S, Fellahi JL, Baumstarck K, Guidon C; PROVECS Study Group. Effect of open-lung vs conventional perioperative ventilation strategies on postoperative pulmonary complications after on-pump cardiac surgery: the PROVECS randomized clinical trial. Intensive Care Med. 2019 Oct;45(10):1401-1412. doi: 10.1007/s00134-019-05741-8. Epub 2019 Oct 1.

  PMID: 31576435 RESULT

Central Study Contacts

Zhichang Wang

CONTACT

+8618255127433; wang15zc@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start: October 9, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Related papers published 3 months later, the IPD will be shared
• Access Criteria: fmguo2022@163.com , wang15zc@163.com

Locations

CN (1)