Effect of Inspired Oxygen Concentration on Postoperative Atelectasis After VATS Right Lobectomy
22. juli 2026 opdateret af: Yi Feng, MD, Peking University People's Hospital
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
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yi Feng, Ph.D
- Telefonnummer: 010-88325590
- E-mail: doc_yifeng@163.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: High-Oxygen Group (FiO₂=100%)
FiO₂=100% throughout one-lung ventilation.
|
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).
|
|
Eksperimentel: Low-Oxygen Group (FiO₂=50%)
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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Non-operated lung atelectasis volume percentage
Tidsramme: 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
|
CT scans were performed at 60 ± 10 minutes after tracheal extubation to assess the volume ratio of atelectasis in the contralateral lung.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of postoperative pulmonary complications
Tidsramme: Postoperative days 1-3
|
PPC defined as Melbourne Postoperative Pulmonary Complication score ≥4
|
Postoperative days 1-3
|
|
QoR-15 quality of recovery score
Tidsramme: Postoperative days 1-3
|
15-item Quality of Recovery questionnaire score
|
Postoperative days 1-3
|
|
Arterial blood gas analysis (oxygenation index)
Tidsramme: Multiple time points: preop room air; 5 minutes after one lung ventilation start; 1 hour after one lung ventilation ; pre-postanesthesia care unit discharge
|
PaO₂/FiO₂ ratio at specified time points
|
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
Tidsramme: Intraoperative (during one lung ventilation)
|
Oxygen saturation (pulse oxygen)
|
Intraoperative (during one lung ventilation)
|
|
Oxygen concentration exposure burden
Tidsramme: Intraoperative (during one lung ventilation)
|
Sum of FiO₂ × time; incidence and frequency of FiO₂ increase
|
Intraoperative (during one lung ventilation)
|
|
Incidence of intraoperative adverse events
Tidsramme: During surgery
|
Incidence of hypoxemia
|
During surgery
|
|
Oxidative stress marker (MDA)
Tidsramme: 1 hour after one lung ventilation
|
Arterial blood malondialdehyde (MDA) level at 1 hour after one lung ventilation
|
1 hour after one lung ventilation
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. december 2027
Studieafslutning (Anslået)
1. december 2027
Datoer for studieregistrering
Først indsendt
18. juli 2026
Først indsendt, der opfyldte QC-kriterier
22. juli 2026
Først opslået (Faktiske)
23. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026PHBXXX
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual participant data will be available upon reasonable request after publication
IPD-delingstidsramme
Immediately following publication, for 3 years
IPD-delingsadgangskriterier
Researchers with a reasonable research purpose, subject to a data use agreement
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
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