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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sigh Ventilation | Experimental | sigh breaths, low tidal volume and moderate PEEP levels |
|
| Conventional Ventilation | Active Comparator | low tidal volume, moderate PEEP levels |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Shock-free days | 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. | From randomization to postoperative day 30 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhichang Wang | Contact | +8618255127433 | wang15zc@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital, Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32902561 | Result | 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. | |
| 31576435 | 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. |
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Study data without patient information
Related papers published 3 months later, the IPD will be shared
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|
| 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% |
|
| 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). | 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). | 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 | From randomization to postoperative day 7 |
| No Ventilatory Support Days by POD30 | Days alive and not receive IMV, HFNC, and NIV support | From randomization to postoperative day 30 |
| Proportion of Acute Respiratory Distress Syndrome through hospitalization | ARDS diagnosed according to the 2023 ATS New Global Definition | From randomization up to hospital discharge, assessed up to postoperative day 30 |
| Intensive Care Unit length of stay by POD30 | From randomization to postoperative day 30 |
| Hospital length of stay by POD30 | From randomization to postoperative day 30 |
| 30-day mortality | The proportion of patients who died within postoperative day 30 | From randomization to postoperative day 30 |
| Barotrauma | Barotrauma includes pneumothorax, pneumomediastinum, or subcutaneous emphysema. | From randomization up to hospital discharge, assessed up to postoperative day 30 |
| Pneumothorax | Pneumothorax detected through chest X-ray or CT scan | From randomization up to hospital discharge, assessed up to postoperative day 30 |
| New-onset atrial fibrillation | New-onset atrial fibrillation detected through ECG | From randomization to hospital discharge, assessed up to postoperative day 30 |
| Ventricular fibrillation | Ventricular fibrillation detected through ECG | From randomization to hospital discharge, assessed up to postoperative day 30 |
| Cardiac arrest | The proportion of patients with cardiac arrest | From randomization to hospital discharge, assessed up to postoperative day 30 |
| Other adverse events | The proportion of other adverse events related to the interventions assessed by investigators | From randomization to hospital discharge, assessed up to postoperative day 30 |