Effect of Inspired Oxygen Concentration on Postoperative Atelectasis in Patients Undergoing Elective Thoracoscopic Pulmonary Lobectomy Based on Perioperative Lung Protection Strategy: A Randomized Controlled Trial
| Registry | NCT07721558 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 100 (Estimated) |
| Sponsor | Peking University People's Hospital (Other) |
| Conditions | Atelectasis, Postoperative Pulmonary Complications |
| Interventions | Low inspired oxygen concentration (FiO₂=50%) during one-lung ventilation, High inspired oxygen concentration (FiO₂=100%) during one-lung ventilaion (Procedure) |
| Dates | start 2026-09-01 (estimated), primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2026-07-23, last updated 2026-08-19 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Atelectasis All trials for Postoperative Pulmonary Complications All trials of Low inspired oxygen concentration (FiO₂=50%) during one-lung ventilation All trials of High inspired oxygen concentration (FiO₂=100%) during one-lung ventilaion
This study aims to investigate whether using 50% FiO₂ during one-lung ventilation, compared with 100% FiO₂, reduces postoperative atelectasis in the non-dependent (healthy) lung of patients undergoing VATS pulmonary lobectomy, based on individualized PEEP titration. This is a single-center, prospective, assessor- and patient-blinded randomized controlled trial. A total of 100 patients (50 per group, including a pilot phase of 10 per group) will be enrolled and randomized 1:1 to the high-oxygen group (FiO₂=100%) and the low-oxygen group (FiO₂=50%). The primary endpoint is the percentage of atelectasis volume in the non-operated lung relative to the total non-operated lung volume, assessed by CT at 60±10 minutes after tracheal extubation.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| High-Oxygen Group (FiO₂=100%) | Active comparator | Procedure: High inspired oxygen concentration (FiO₂=100%) during one-lung ventilaion | FiO₂=100% throughout one-lung ventilation. |
| Low-Oxygen Group (FiO₂=50%) | Experimental | Procedure: Low inspired oxygen concentration (FiO₂=50%) during one-lung ventilation | Initial FiO₂=50% during one-lung ventilation (maintaining SpO₂≥92%) with individualized PEEP titration. If SpO₂<92%, increase FiO₂ by 10% increments; if SpO₂<90% and FiO₂ already at 100%, initiate rescue ventilation. |
Sex: All, ages: 18 Years to 65 Years
Inclusion Criteria: Age 18-65 years Elective thoracoscopic (VATS) pulmonary lobectomy Anticipated one-lung ventilation duration >1 hour ASA physical status I-III Exclusion Criteria: Previous pulmonary surgery (including lobectomy, lung volume reduction surgery, or other lung resection) Pre-existing significant atelectasis (large collapse on preoperative CT) Contraindications to PEEP: intracranial hypertension, bronchopleural fistula, hypovolemic shock, right heart failure, giant bullae, pneumothorax Preoperative continuous oxygen therapy or mechanical ventilation, moderate-severe COPD BMI ≥ 30 kg/m² Ischemic cardiovascular and cerebrovascular diseases, such as myocardial infarction, ischemic stroke, and patients with coronary or cerebrovascular stents Patient refusal to participate Withdrawal Criteria / Major Protocol Deviations: Surgery changed to simple wedge resection Severe pleural adhesions (found intraoperatively) One-lung ventilation duration < 50 minutes Intraoperative blood loss > 500 ml Severe hypotension (MAP < 55 mmHg despite high-dose vasopressors) Unexpected non-thoracic surgical procedure Ventilation protocol interrupted (e.g., FiO₂ exposure < 80% of planned time in the low-oxygen group) Postoperative CT not completed or image quality unusable Subject withdrawal of informed consent
| Facility | City | Country | Status |
|---|---|---|---|
| Department of Anesthesiology, Peking University People's Hospital | Beijing, Beijing Municipality | China |