Effect of Different Inspired Oxygen Concentrations on Intraoperative Recruitment Outcomes in Pati… (NCT06746181) | Clinical Trial Compass
CompletedNot Applicable
Effect of Different Inspired Oxygen Concentrations on Intraoperative Recruitment Outcomes in Patients Undergoing Abdominal Surgery
China95 participantsStarted 2025-04-01
Plain-language summary
This study intends to evaluate the effect of different inhaled oxygen concentrations on the effect of lung recruitment in patients undergoing abdominal surgery. During perioperative mechanical ventilation, higher FiO2 is usually given to prevent the occurrence of hypoxemia, but there are no conclusions about the setting of optimal FiO2 during surgery.
Dynamic pulmonary compliance enables real-time monitoring of alveolar changes and is used to assess pulmonary function in intraoperative patients. The value of compliance represents the number of air-containing alveoli; the more alveoli are trapped, the less air-containing tissue there is and the lower the compliance. Lung recruitment, as part of a lung-protective ventilation strategy, is effective in opening alveoli and improving oxygenation. This single-center, randomized controlled trial will explore the optimal inspired oxygen concentration that allows patients to benefit from lung recruitment and the duration of improvement in lung compliance after lung recruitment.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ASA physical status classification: I or II.
* Adults aged 18 to 64 years, regardless of gender.
* BMI between 18 kg/m² and 25 kg/m².
* Patients undergoing elective abdominal surgery under general anesthesia.
* Patients with estimated operating time ≥1.5h and intraoperative bleeding ≤500ml.
* Patients who have provided written informed consent after understanding the study purpose, procedures, and potential risks.
Exclusion Criteria:
* Previous thoracic surgery.
* Chest X-ray or CT suggestive of pneumothorax or alveoli.
* Lung disease: chronic bronchitis, asthma, moderate to severe obstructive ventilatory dysfunction.
* Preoperative pulse oxygen saturation (SpO2) \<90% on breathing air or SpO2 \<95% on oxygen.
* Contraindications to lung reanimation: high intracranial pressure, hypovolemic shock, right heart failure.
* Severe heart disease (New York Heart Association, NYHA class III or IV.
* Acute coronary syndrome or sustained ventricular tachyarrhythmia).
* Participation in other interventional studies or refusal of enrollment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.