Sigh Ventilation in Cardiac Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhongda Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Emergence surgery;
Left ventricular assist device implantation;
Planned thoracotomy with one lung ventilation;
Undergo concurrent surgical procedures outside cardiology;
Trial design
Design model
Parallel
Treatments tested in this trial
Sigh Breaths
Other interventionSigh 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
Other intervention6-8ml/kg predicted body weight
Moderate PEEP
Other interventionPEEP set according to ARDSnet low PEEP- fraction of inspired oxygen table, FiO2 was set as the lowest fraction targeted to maintain SpO2 ≥ 96%
Treatment groups
686 Participants
are divided into 2 treatment groupsGroup A: Sigh VentilationExperimental treatment 3 interventions
Group B: Conventional VentilationActive comparator 2 interventions
Trial outcomes
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).
Time frame
From randomization to postoperative day 7Secondary outcomes
1
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).
Time frame
From randomization to postoperative day 72
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).
Time frame
From randomization up to hospital discharge, assessed up to postoperative day 303
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).
Time frame
From randomization up to hospital discharge, assessed up to postoperative day 304
No Ventilatory Support Days by POD7
Days alive and not receive IMV, HFNC, and NIV support
Time frame
From randomization to postoperative day 7Other outcomes
1
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.
Time frame
From randomization to postoperative day 302
Barotrauma
Barotrauma includes pneumothorax, pneumomediastinum, or subcutaneous emphysema.
Time frame
From randomization up to hospital discharge, assessed up to postoperative day 303
Pneumothorax
Pneumothorax detected through chest X-ray or CT scan
Time frame
From randomization up to hospital discharge, assessed up to postoperative day 304
New-onset atrial fibrillation
New-onset atrial fibrillation detected through ECG
Time frame
From randomization to hospital discharge, assessed up to postoperative day 30Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov