Postoperative Pulmonary Complications (PPCs)NCT07024420
Sigh Ventilation in Cardiac Surgery
A study testing Sigh Breaths, Low Tidal Volume and Moderate PEEP in people with Postoperative Pulmonary Complications (PPCs) and Cardiac Surgery in Adult Patient, run by Zhongda Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pulmonary Complications (PPCs), Cardiac Surgery in Adult Patient
- What is being tested?
- Sigh Breaths, Low Tidal Volume and Moderate PEEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 686 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Preoperative shock;
- Preoperative Hypoxemia (PaO2<60mmHg OR SpO2<90% on ambient air);
- Preoperative left ventricular ejection fraction < 40%;
- Systolic pulmonary artery pressure > 50 mmHg.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009
Zhichang Wang, M.D., +8615261887038, wang15zc@163.com
Fengmei Guo, Ph.D, M.D
About this study
Official title: Effect of Sigh Ventilation on Postoperative Pulmonary Complications in Cardiac Surgery: A Multicenter, Randomized Controlled Trial
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.
Read the detailed description
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.
- Being tested
- Sigh Breaths, Low Tidal Volume, Moderate PEEP
- Keywords
- Sigh Ventilation, Cardiac Surgery, Postoperative Pulmonary Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sigh BreathsOther
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 VolumeOther
6-8ml/kg predicted body weight
Moderate PEEPOther
PEEP set according to ARDSnet low PEEP- fraction of inspired oxygen table, FiO2 was set as the lowest fraction targeted to maintain SpO2 ≥ 96%
| Study group | Role | What they receive |
|---|---|---|
| Sigh Ventilation | Experimental | sigh breaths, low tidal volume and moderate PEEP levels Receives: Other: Sigh Breaths; Other: Low Tidal Volume; Other: Moderate PEEP |
| Conventional Ventilation | Active comparator | low tidal volume, moderate PEEP levels Receives: Other: Low Tidal Volume; Other: Moderate PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From randomization to postoperative day 7
Secondary outcomes (9)
Severity of postoperative pulmonary complications through POD7
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).
Measured: From randomization to postoperative day 7
Proportion of major postoperative pulmonary complications (Grade ≥ 3 ) through hospitalization
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).
Measured: From randomization up to hospital discharge, assessed up to postoperative day 30
Severity of postoperative pulmonary complications through hospitalization
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).
Measured: From randomization up to hospital discharge, assessed up to postoperative day 30
No Ventilatory Support Days by POD7
Days alive and not receive IMV, HFNC, and NIV support
Measured: From randomization to postoperative day 7
No Ventilatory Support Days by POD30
Days alive and not receive IMV, HFNC, and NIV support
Measured: From randomization to postoperative day 30
Proportion of Acute Respiratory Distress Syndrome through hospitalization
ARDS diagnosed according to the 2023 ATS New Global Definition
Measured: From randomization up to hospital discharge, assessed up to postoperative day 30
Intensive Care Unit length of stay by POD30
Measured: From randomization to postoperative day 30
Hospital length of stay by POD30
Measured: From randomization to postoperative day 30
30-day mortality
The proportion of patients who died within postoperative day 30
Measured: From randomization to postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start9 Oct 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pulmonary Complications (PPCs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 686 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengmei Guo, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024420
- Sponsor's protocol ID
- SIVECS
- Status last verified
- Sep 2025
- First submitted
- 9 Jun 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data without patient information
Publications
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.
PubMed 32902561Lagier 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.
PubMed 31576435
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sigh Ventilation on Postoperative Pulmonary Complications in Cardiac Surgery: A Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07024420
- Acronym / sponsor ID
- SIVECS
- Keywords
- Sigh Ventilation, Cardiac Surgery, Postoperative Pulmonary Complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 686 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sigh Ventilation | Experimental | Other: Sigh Breaths, Other: Low Tidal Volume, Other: Moderate PEEPsigh breaths, low tidal volume and moderate PEEP levels |
| Conventional Ventilation | Active comparator | Other: Low Tidal Volume, Other: Moderate PEEPlow tidal volume, moderate PEEP levels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- Emergence surgery;
- Left ventricular assist device implantation;
- Planned thoracotomy with one lung ventilation;
- Undergo concurrent surgical procedures outside cardiology;
- Neuromuscular illness;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sigh BreathsSigh 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. | Other | Sigh Ventilation |
| Low Tidal Volume6-8ml/kg predicted body weight | Other | Conventional Ventilation, Sigh Ventilation |
| Moderate PEEPPEEP set according to ARDSnet low PEEP- fraction of inspired oxygen table, FiO2 was set as the lowest fraction targeted to maintain SpO2 ≥ 96% | Other | Conventional Ventilation, Sigh Ventilation |
Primary outcome
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).
9 secondary outcomes
Severity of postoperative pulmonary complications through POD7
Time frame: From randomization to postoperative day 7
Proportion of major postoperative pulmonary complications (Grade ≥ 3 ) through hospitalization
Time frame: From randomization up to hospital discharge, assessed up to postoperative day 30
Severity of postoperative pulmonary complications through hospitalization
Time frame: From randomization up to hospital discharge, assessed up to postoperative day 30
No Ventilatory Support Days by POD7
Time frame: From randomization to postoperative day 7
No Ventilatory Support Days by POD30
Time frame: From randomization to postoperative day 30
Proportion of Acute Respiratory Distress Syndrome through hospitalization
Time frame: From randomization up to hospital discharge, assessed up to postoperative day 30
Intensive Care Unit length of stay by POD30
Time frame: From randomization to postoperative day 30
Hospital length of stay by POD30
Time frame: From randomization to postoperative day 30
30-day mortality
Time frame: From randomization to postoperative day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Results publication: PubMed 32902561Lagier 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.
- Results publication: PubMed 31576435Lagier 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.
- Individual participant dataSharing planned: Yes. Study data without patient information
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sigh Breaths, Low Tidal Volume and Moderate PEEP in people with Postoperative Pulmonary Complications (PPCs) and Cardiac Surgery in Adult Patient, run by Zhongda Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhichang Wang (+8618255127433, wang15zc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of major postoperative pulmonary complications (Grade ≥ 3 ) through POD7 (time frame: From randomization to postoperative day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07024420, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.