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Not yet recruiting NCT07721558

Effect of Inspired Oxygen Concentration on Postoperative Atelectasis After VATS Right Lobectomy

No phase Interventional Atelectasis Postoperative Pulmonary Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low inspired oxygen concentration (FiO₂=50%) during one-lung ventilation, High inspired oxygen concentration (FiO₂=100%) during one-lung ventilaion.
Who it may be relevant to
Registry conditions: Atelectasis, Postoperative Pulmonary Complications. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Inspired Oxygen Concentration on Postoperative Atelectasis in Patients Undergoing Elective Thoracoscopic Right Pulmonary Lobectomy Based on Perioperative Lung Protection Strategy: A Randomized Controlled Trial

Overview

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 right 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 90±10 minutes postoperatively.

Interventions

  • Procedure Low inspired oxygen concentration (FiO₂=50%) during one-lung ventilation
    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.
  • Procedure High inspired oxygen concentration (FiO₂=100%) during one-lung ventilaion
    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 outcome measures

  • 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.]
Secondary outcome measures (7)
  • Incidence of postoperative pulmonary complications [Time frame: Postoperative days 1-3]
  • QoR-15 quality of recovery score [Time frame: Postoperative days 1-3]
  • Arterial blood gas analysis (oxygenation index) [Time frame: Multiple time points: preop room air; 5 minutes after one lung ventilation start; 1 hour after one lung ventilation ; pre-postanesthesia care unit discharge]
  • Intraoperative oxygen saturationo [Time frame: Intraoperative (during one lung ventilation)]
  • Oxygen concentration exposure burden [Time frame: Intraoperative (during one lung ventilation)]
  • Incidence of intraoperative adverse events [Time frame: During surgery]
  • Oxidative stress marker (MDA) [Time frame: 1 hour after one lung ventilation]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

Previous lobectomy or lung volume reduction surgery Pre-existing significant atelectasis (large collapse on preoperative CT) Contraindications to PEEP: intracranial hypertension, bronchopleural fistula, hypovolemic shock, right heart failure, giant bullae, pneumothorax FiO₂ restrictions: preoperative continuous oxygen therapy or mechanical ventilation, moderate-severe COPD BMI ≥ 30 kg/m² Patient refusal to participate

Withdrawal Criteria / Major Protocol Deviations:

Surgery changed to simple wedge resection Severe pleural adhesions (found intraoperatively) Ventilation protocol interrupted Intraoperative blood loss >500 ml Severe hypotension (MAP<55 mmHg despite high-dose vasopressors) Unexpected non-thoracic surgical procedure FiO₂ exposure <80% of planned time (experimental group) Postoperative CT not completed or image quality unusable

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07721558 · 2026PHBXXX

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗