Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07721558

Effect of Inspired Oxygen Concentration on Postoperative Atelectasis After VATS Lobectomy

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Atelectasis Lung Diseases Postoperative Pulmonary Complications Pulmonary Atelectasis Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, Peking University People's Hospital

Beijing, Beijing Municipality, 100000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

  1. Non-operated lung atelectasis volume percentage

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

    Chest CT at 60±10 minutes after tracheal extubation

Secondary outcomes

  1. Incidence of postoperative pulmonary complications

    Time frame: Postoperative days 1-3

    PPC defined as Melbourne Postoperative Pulmonary Complication score ≥4

  2. QoR-15 quality of recovery score

    Time frame: Postoperative days 1-3

    15-item Quality of Recovery questionnaire score

  3. Arterial blood gas analysis (oxygenation index)

    Time frame: 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

    PaO₂/FiO₂ ratio, PaO₂, PaCO₂, and pH at five predefined time points

  4. Intraoperative oxygen saturation

    Time frame: Intraoperative (during one lung ventilation)

    Oxygen saturation (pulse oxygen)

  5. Oxygen concentration exposure burden

    Time frame: Intraoperative (during one lung ventilation)

    Sum of FiO₂ × time; incidence and frequency of FiO₂ increase

  6. Incidence of intraoperative adverse events

    Time frame: Intraoperative (from induction to emergence)

    Incidence of intraoperative adverse events including hypoxemia (SpO₂ < 90%), hypotension (MAP decreased > 20% from baseline for > 3 minutes), new-onset arrhythmia, and cerebral oxygen desaturation (rSO₂ < 50% or > 20% decrease from baseline)

  7. Oxidative stress marker (MDA)

    Time frame: 1 hour after one lung ventilation

    Arterial blood malondialdehyde (MDA) level at 1 hour after one lung ventilation

  8. Postoperative renal function (serum creatinine and eGFR)

    Time frame: Postoperative days 1 and 3

    Serum creatinine (SCr) and estimated glomerular filtration rate (eGFR) to assess postoperative acute kidney injury

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Feng, Ph.D

CONTACT

[email protected]

010-88325590

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.