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Effect of Inspired Oxygen Concentration on Postoperative Atelectasis After VATS Lobectomy

ConditionsAtelectasisPostoperative Pulmonary Complications
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPeking University People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    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/Surgery

    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).

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: High-Oxygen Group (FiO₂=100%)Active comparator 1 intervention
Group B: Low-Oxygen Group (FiO₂=50%)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Non-operated lung atelectasis volume percentage

Chest CT at 60±10 minutes after tracheal extubation

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 outcomes

1

Incidence of postoperative pulmonary complications

PPC defined as Melbourne Postoperative Pulmonary Complication score ≥4

Time frame
Postoperative days 1-3
2

QoR-15 quality of recovery score

15-item Quality of Recovery questionnaire score

Time frame
Postoperative days 1-3
3

Arterial blood gas analysis (oxygenation index)

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

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
4

Intraoperative oxygen saturation

Oxygen saturation (pulse oxygen)

Time frame
Intraoperative (during one lung ventilation)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University People's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: