Postoperative Pulmonary Complications (PPCs), Cardiac Surgery in Adult Patient
Conditions
Keywords
Sigh Ventilation, Cardiac Surgery, Postoperative Pulmonary Complications
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.
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.
Interventions
OTHERSigh 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.
OTHERLow Tidal Volume
6-8ml/kg predicted body weight
OTHERModerate 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%
Sponsors
Zhongda Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of major postoperative pulmonary complications (Grade ≥ 3 ) through POD7 | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of major postoperative pulmonary complications (Grade ≥ 3 ) through hospitalization | 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). |
| Severity of postoperative pulmonary complications through hospitalization | 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). |
| No Ventilatory Support Days by POD7 | From randomization to postoperative day 7 | Days alive and not receive IMV, HFNC, and NIV support |
| No Ventilatory Support Days by POD30 | From randomization to postoperative day 30 | Days alive and not receive IMV, HFNC, and NIV support |
| Proportion of Acute Respiratory Distress Syndrome through hospitalization | From randomization up to hospital discharge, assessed up to postoperative day 30 | ARDS diagnosed according to the 2023 ATS New Global Definition |
| 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 | From randomization to postoperative day 30 | The proportion of patients who died within postoperative day 30 |
| Severity of postoperative pulmonary complications through POD7 | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pneumothorax | From randomization up to hospital discharge, assessed up to postoperative day 30 | Pneumothorax detected through chest X-ray or CT scan |
| New-onset atrial fibrillation | From randomization to hospital discharge, assessed up to postoperative day 30 | New-onset atrial fibrillation detected through ECG |
| Ventricular fibrillation | From randomization to hospital discharge, assessed up to postoperative day 30 | Ventricular fibrillation detected through ECG |
| Cardiac arrest | From randomization to hospital discharge, assessed up to postoperative day 30 | The proportion of patients with cardiac arrest |
| Other adverse events | From randomization to hospital discharge, assessed up to postoperative day 30 | The proportion of other adverse events related to the interventions assessed by investigators |
| Barotrauma | From randomization up to hospital discharge, assessed up to postoperative day 30 | Barotrauma includes pneumothorax, pneumomediastinum, or subcutaneous emphysema. |
| Shock-free days | 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. |
Countries
China
Contacts
Primary ContactZhichang Wang
Outcome results
None listed