Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT02090205
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years old
* Ability to provide an informed consent
* Elective surgery
* Surgical intervention with cardio-pulmonary bypass, aortic clamp and cardioplegia
* Cardiac valvular surgery, coronary artery surgery, ascending aortic surgery and/or combined
* Planned cardiac surgery with median sternotomy and bi-pulmonary ventilation
Exclusion Criteria:
* Patient refusal to provide informed consent
* Emergency surgery
* Patients with previous cardiac surgery
* Cardiac surgery with planned circulatory arrest or aortic endoprosthesis or TAVI/MitraClip
* Planned thoracotomy with one lung ventilation
* Patients with BMI \>30
* Patients with chronic kidney insufficiency (defined as dialysis)
* Patients with known respiratory diseases (current respiratory infections, asthma, chronic obstructive pulmonary disease, obstructive apnea syndrome)
* Patients already intubated in the peri-operative period
* Patients with pneumonia in the pre-operative period (30 days before surgery)
* Patients with previous thoracic surgery (pulmonary resection)
* Patients with: oxygen saturation \< 90% and/or oxygen arterial pressure \< 60 mmHg and/or P/F ratio \<300 and/or carbon dioxide pressure \> 45 mmHg
* Patients with levels of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels increased \>= 2 folds above the upper limit.
* Patients with ejection fraction \< 40%
* Patients with pulmonary hypertension (defined as PAPm \> 30mmHg)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT02090205
Study Brief:
Protocol Section:
NCT02090205