Effect of Inspired Oxygen Concentration on Postoperative Atelectasis After VATS Lobectomy

NCT07721558 | Not Yet Recruiting

• 1 other identifier: 2026PHBXXX
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atelectasis; Postoperative Pulmonary Complications

Keywords

Inspired oxygen concentration; One-lung ventilation; Lung recruitment maneuver

Outcome Measures

Primary Outcomes (1)

• Non-operated lung atelectasis volume percentage

  Chest CT at 60±10 minutes after tracheal extubation

  CT scans were performed at 60 ± 10 minutes after tracheal extubation to assess the volume ratio of atelectasis in the contralateral lung.

Secondary Outcomes (8)

• Incidence of postoperative pulmonary complications

  Postoperative days 1-3

• QoR-15 quality of recovery score

  Postoperative days 1-3

• Arterial blood gas analysis (oxygenation index)

  Multiple time points: (1) preoperative preparation room; (2) 5 minutes after two-lung ventilation at induction; (3) 5 minutes after one-lung ventilation start; (4) 1 hour after one-lung ventilation; (5) 10 minutes after tracheal extubation

• Intraoperative oxygen saturation

  Intraoperative (during one lung ventilation)

• Oxygen concentration exposure burden

  Intraoperative (during one lung ventilation)

Study Arms (2)

High-Oxygen Group (FiO₂=100%)

ACTIVE COMPARATOR

FiO₂=100% throughout one-lung ventilation.

Procedure: High inspired oxygen concentration (FiO₂=100%) during one-lung ventilaion

Low-Oxygen Group (FiO₂=50%)

EXPERIMENTAL

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.

Procedure: Low inspired oxygen concentration (FiO₂=50%) during one-lung ventilation

Interventions

Low inspired oxygen concentration (FiO₂=50%) during one-lung ventilation PROCEDURE

Ventilation with initial FiO₂=50% during one-lung ventilation, combined with individualized PEEP titration. Oxygen concentration is dynamically adjusted based on SpO₂; ventilation duration at each FiO₂ level and total oxygen exposure burden are recorded.

Low-Oxygen Group (FiO₂=50%)

High inspired oxygen concentration (FiO₂=100%) during one-lung ventilaion PROCEDURE

Ventilation with FiO₂=100% throughout one-lung ventilation, combined with individualized PEEP titration (decremental PEEP titration selecting the highest PEEP corresponding to the lowest driving pressure).

High-Oxygen Group (FiO₂=100%)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years Elective thoracoscopic (VATS) pulmonary lobectomy Anticipated one-lung ventilation duration \>1 hour ASA physical status I-III

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Department of Anesthesiology, Peking University People's Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yi Feng, Ph.D

CONTACT

010-88325590; doc_yifeng@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients are blinded pre- and postoperatively; postoperative data collectors, CT readers, and biostatisticians are blinded to allocation; only the attending anesthesiologist is unblinded due to the nature of the intervention (setting FiO₂), but does not participate in data collection or outcome assessment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Anesthesiology

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 23, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Immediately following publication, for 3 years
• Access Criteria: Researchers with a reasonable research purpose, subject to a data use agreement

Locations

CN (1)