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:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT02148692
Eligibility Criteria:
Inclusion Criteria:
* Patient scheduled for open or laparoscopic surgery under general anesthesia
* Intermediate-to-high risk for PPCs following surgery, according to the ARISCAT risk score (≥ 26)
* BMI ≥ 35 kg/m2
* Expected duration of surgery ≥ 2 h
Exclusion Criteria:
* Age \< 18 years
* Previous lung surgery (any)
* Persistent hemodynamic instability, intractable shock (considered hemodynamically unsuitable for the study by the patient's managing physician)
* History of previous severe chronic obstructive pulmonary disease (COPD) (non-invasive ventilation and/or oxygen therapy at home, repeated systemic corticosteroid therapy for acute exacerbations of COPD)
* Recent immunosuppressive medication (patients receiving chemotherapy or radiation therapy up to two months prior to surgery)
* Severe cardiac disease (New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmias)
* Invasive mechanical ventilation longer than 30 minutes (e.g., general anesthesia for surgery) within last 30 days
* Pregnancy (excluded by anamneses and/or laboratory analysis)
* Prevalent acute respiratory distress syndrome expected to require prolonged postoperative mechanical ventilation
* Severe pulmonary arterial hypertension, defined as systolic pulmonary artery pressure \> 40 mmHg
* Intracranial injury or tumor
* Neuromuscular disease (any)
* Need for intraoperative prone or lateral decubitus position
* Need for one-lung ventilation
* Cardiac surgery
* Neurosurgery
* Planned reintubation following surgery
* Enrolled in other interventional study or refusal of informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02148692
Study Brief:
Protocol Section:
NCT02148692