AtelectasisNCT07721558
Effect of Inspired Oxygen Concentration on Postoperative Atelectasis After VATS Lobectomy
A study testing Low inspired oxygen concentration (FiO₂=50%) during one-lung ventilation and High inspired oxygen concentration (FiO₂=100%) during one-lung ventilaion in people with Atelectasis and Postoperative Pulmonary Complications, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atelectasis, Postoperative Pulmonary Complications
- What is being tested?
- Low inspired oxygen concentration (FiO₂=50%) during one-lung ventilation and High inspired oxygen concentration (FiO₂=100%) during one-lung ventilaion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years Elective thoracoscopic (VATS) pulmonary lobectomy Anticipated one-lung ventilation duration >1 hour ASA physical status I-III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Anesthesiology, Peking University People's Hospital
Beijing, Beijing Municipality, 100000
About this study
Official 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
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
- Being tested
- Low inspired oxygen concentration (FiO₂=50%) during one-lung ventilation, High inspired oxygen concentration (FiO₂=100%) during one-lung ventilaion
- Keywords
- Inspired oxygen concentration, One-lung ventilation, Lung recruitment maneuver
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low inspired oxygen concentration (FiO₂=50%) during one-lung ventilationProcedure or 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 ventilaionProcedure or 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).
| Study group | Role | What they receive |
|---|---|---|
| High-Oxygen Group (FiO₂=100%) | Active comparator | FiO₂=100% throughout one-lung ventilation. Receives: 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. Receives: Procedure: Low inspired oxygen concentration (FiO₂=50%) during one-lung ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-operated lung atelectasis volume percentage
Chest CT at 60±10 minutes after tracheal extubation
Measured: 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
PPC defined as Melbourne Postoperative Pulmonary Complication score ≥4
Measured: Postoperative days 1-3
QoR-15 quality of recovery score
15-item Quality of Recovery questionnaire score
Measured: Postoperative days 1-3
Arterial blood gas analysis (oxygenation index)
PaO₂/FiO₂ ratio, PaO₂, PaCO₂, and pH at five predefined time points
Measured: 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
Oxygen saturation (pulse oxygen)
Measured: Intraoperative (during one lung ventilation)
Oxygen concentration exposure burden
Sum of FiO₂ × time; incidence and frequency of FiO₂ increase
Measured: Intraoperative (during one lung ventilation)
Incidence of intraoperative adverse events
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)
Measured: Intraoperative (from induction to emergence)
Oxidative stress marker (MDA)
Arterial blood malondialdehyde (MDA) level at 1 hour after one lung ventilation
Measured: 1 hour after one lung ventilation
Postoperative renal function (serum creatinine and eGFR)
Serum creatinine (SCr) and estimated glomerular filtration rate (eGFR) to assess postoperative acute kidney injury
Measured: Postoperative days 1 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721558
- Sponsor's protocol ID
- 2026PHBXXX
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be available upon reasonable request after publication
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07721558
- Acronym / sponsor ID
- 2026PHBXXX
- Conditions
- Atelectasis, Postoperative Pulmonary Complications
- Keywords
- Inspired oxygen concentration, One-lung ventilation, Lung recruitment maneuver
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Oxygen Group (FiO₂=100%) | Active comparator | Procedure: High inspired oxygen concentration (FiO₂=100%) during one-lung ventilaionFiO₂=100% throughout one-lung ventilation. |
| Low-Oxygen Group (FiO₂=50%) | Experimental | Procedure: Low inspired oxygen concentration (FiO₂=50%) during one-lung ventilationInitial 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-65 years Elective thoracoscopic (VATS) pulmonary lobectomy Anticipated one-lung ventilation duration >1 hour ASA physical status I-III
Key exclusion criteria (3 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low inspired oxygen concentration (FiO₂=50%) during one-lung ventilationVentilation 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 or surgery | Low-Oxygen Group (FiO₂=50%) |
| High inspired oxygen concentration (FiO₂=100%) during one-lung ventilaionVentilation 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). | Procedure or surgery | High-Oxygen Group (FiO₂=100%) |
Primary outcome
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
8 secondary outcomes
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: (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
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: Intraoperative (from induction to emergence)
Oxidative stress marker (MDA)
Time frame: 1 hour after one lung ventilation
Postoperative renal function (serum creatinine and eGFR)
Time frame: Postoperative days 1 and 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be available upon reasonable request after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low inspired oxygen concentration (FiO₂=50%) during one-lung ventilation and High inspired oxygen concentration (FiO₂=100%) during one-lung ventilaion in people with Atelectasis and Postoperative Pulmonary Complications, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Feng, Ph.D (010-88325590, doc_yifeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.