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 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT03288558
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years old
* Scheduled for elective Coronary Artery Bypass Graft, Single valve repair or replacement, or Coronary Artery Bypass Graft plus Single Valve repair or replacement, with the use of Cardiopulmonary Bypass (CPB), aortic clamp and cardioplegia, sternotomy
Exclusion Criteria:
* Pregnancy
* Clinically significant Congenital Heart Disease
* Surgery with planned thoracotomy approach with one lung ventilation
* Body mass index (the weight in kilograms divided by the square of the height in meters) of 40 or higher,
* Receipt of positive pressure mechanical ventilation (invasive and non-invasive) within the 2 weeks preceding surgery (excluding routine treatment for obstructive sleep apnea syndrome)
* Severe chronic respiratory disease, as indicated by any of:
* Baseline FEV1 \< 20 ml/kg predicted body weight
* Pre-existing chronic interstitial lung disease with chronic interstitial infiltration on chest X-ray
* Documented chronic CO2 retention (PaCO2 \> 50 mm Hg) and/or chronic hypoxaemia (PaO2\<55 mmHg on FiO2 = 0.21)
* Chronic restrictive, obstructive, neuromuscular, chest wall or pulmonary vascular disease resulting in severe exercise restriction (e.g., unable to climb stairs or perform household duties), secondary polycythaemia, severe pulmonary hypertension (mean PAP \> 40 mmHg), or ventilator dependency
* Requirement for urgent/emergent surgery
* Progressive neuromuscular illness\* that will result in prolonged need for mechanical ventilation
* Previous randomization in this trial
* Consent refusal
* Surgeon, anesthesiologist, intensivist refusal
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03288558
Study Brief:
Protocol Section:
NCT03288558