- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07494006
Spontaneous Breathing Mode: A Risk for Hypoxemia During OLV? (OLV)
March 20, 2026 updated by: Yi Feng, MD, Peking University People's Hospital
Association Between Spontaneous Breathing Mode and Hypoxemia During One-Lung Ventilation Under General Anesthesia
Patients undergoing thoracic surgery with one-lung ventilation (OLV) are prone to hypoxemia, which is primarily attributable to pulmonary ventilation-perfusion (V/Q) mismatch.
This study will preoperatively assess the distribution of pulmonary ventilation under spontaneous breathing and intraoperatively record the lowest peripheral oxygen saturation (SpO₂) during OLV.
The aim is to investigate the correlation between these two parameters.
The findings are expected to facilitate the prediction of hypoxemia in thoracic surgical patients undergoing OLV.
Study Overview
Status
Enrolling by invitation
Conditions
Study Type
Observational
Enrollment (Estimated)
44
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 100044
- Peking University People's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients who underwent thoracoscopic partial pulmonary resection at Peking University People's Hospital
Description
Inclusion Criteria:
Age ≥ 18 years
- BMI > 18.5 and < 30
- Informed consent obtained
Exclusion Criteria:
• Inability to use the EIT belt preoperatively
- Failure to implement one-lung ventilation during surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Ventilation-Matched Group
In this patient group, the dependent lung exhibited better ventilation in the lateral decubitus position during spontaneous breathing than in the supine position.
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Ventilation-Mismatched Group
In this patient group, ventilation of the dependent lung during spontaneous breathing in the lateral decubitus position was less effective than that in the supine position.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Lowest SpO₂ during OLV
Time Frame: Perioperative
|
We will record the value of the lowest peripheral oxygen saturation (SpO₂) during intraoperative one-lung ventilation.
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Perioperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative functional status
Time Frame: Follow-up assessments with both questionnaires were conducted at 6 and 12 months postoperatively.
|
After hospital discharge, The Lung Cancer Symptom Scale (LCSS) questionnaires will be administered to patients via telephone by trained follow-up personnel.
LCSS typically includes items that evaluate the intensity of symptoms such as cough, dyspnea, pain, fatigue, appetite loss, and insomnia, as well as the impact of these symptoms on daily activities.
Each item is rated on a numerical scale, and the total score reflects the overall symptom burden, with higher scores indicating more severe symptoms.
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Follow-up assessments with both questionnaires were conducted at 6 and 12 months postoperatively.
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postoperative quality of life
Time Frame: Follow-up assessments with both questionnaires were conducted at 6 and 12 months postoperatively.
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After hospital discharge, The Cancer Therapy-Lung (FACT-L) questionnaire will be administered to patients via telephone by trained follow-up personnel.
FACT-L is a widely used quality-of-life questionnaire that combines the general FACT-G (General) items with a lung-cancer-specific (LCS) module .Scores are calculated for each domain and a total score, with higher scores indicating better quality of life.
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Follow-up assessments with both questionnaires were conducted at 6 and 12 months postoperatively.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.
- Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.
- Hollen PJ, Gralla RJ, Kris MG, Potanovich LM. Quality of life assessment in individuals with lung cancer: testing the Lung Cancer Symptom Scale (LCSS). Eur J Cancer. 1993;29A Suppl 1:S51-8. doi: 10.1016/s0959-8049(05)80262-x.
- Spinelli E, Perez J, Chiavieri V, Leali M, Mansour N, Madotto F, Rosso L, Panigada M, Grasselli G, Vaira V, Mauri T. Pathophysiological Markers of Acute Respiratory Distress Syndrome Severity Are Correlated With Ventilation-Perfusion Mismatch Measured by Electrical Impedance Tomography. Crit Care Med. 2025 Jan 1;53(1):e42-e53. doi: 10.1097/CCM.0000000000006458. Epub 2024 Oct 24.
- Handel C, Becher T, Miedema M, Kallio M, Papadouri T, Waldmann AD, Sophocleous L, Karaoli C, Yerworth R, Bayford R, Rimensberger PC, van Kaam AH, Frerichs I. Effect of routine suction on lung aeration in critically ill neonates and young infants measured with electrical impedance tomography. Sci Rep. 2023 Nov 27;13(1):20842. doi: 10.1038/s41598-023-42965-7.
- Arriagada R, Bachmann MC, San Martin C, Rauseo M, Battaglini D. Electrical impedance tomography: Usefulness for respiratory physiotherapy in critical illnesses. Med Intensiva (Engl Ed). 2024 Jul;48(7):403-410. doi: 10.1016/j.medine.2024.03.006. Epub 2024 Mar 27.
- Scaramuzzo G, Pavlovsky B, Adler A, Baccinelli W, Bodor DL, Damiani LF, Franchineau G, Francovich J, Frerichs I, Giralt JAS, Grychtol B, He H, Katira BH, Koopman AA, Leonhardt S, Menga LS, Mousa A, Pellegrini M, Piraino T, Priani P, Somhorst P, Spinelli E, Handel C, Suarez-Sipmann F, Wisse JJ, Becher T, Jonkman AH. Electrical impedance tomography monitoring in adult ICU patients: state-of-the-art, recommendations for standardized acquisition, processing, and clinical use, and future directions. Crit Care. 2024 Nov 19;28(1):377. doi: 10.1186/s13054-024-05173-x.
- Xiao L, Yu K, Yang JJ, Liu WT, Liu L, Miao HH, Li TZ. Effect of individualized positive end-expiratory pressure based on electrical impedance tomography guidance on pulmonary ventilation distribution in patients who receive abdominal thermal perfusion chemotherapy. Front Med (Lausanne). 2023 Sep 5;10:1198720. doi: 10.3389/fmed.2023.1198720. eCollection 2023.
- Jiang L, Deng Y, Xu F, Qiao S, Wang C. Individualized PEEP guided by EIT in patients undergoing general anesthesia: A systematic review and meta-analysis. J Clin Anesth. 2024 Jun;94:111397. doi: 10.1016/j.jclinane.2024.111397. Epub 2024 Jan 25.
- Li X, Li M, Zhou J, Feng Y, Zhang K, Xu H, Wang Z, Tian X. EIT Observed Hypoxemia Caused by V/Q Mismatch During One-Lung Ventilation With Indocyanine Green Inhalation: A Report of Two Cases. Respirol Case Rep. 2025 Apr 24;13(4):e70154. doi: 10.1002/rcr2.70154. eCollection 2025 Apr.
- Shum S, Huang A, Slinger P. Hypoxaemia during one lung ventilation. BJA Educ. 2023 Sep;23(9):328-336. doi: 10.1016/j.bjae.2023.05.006. Epub 2023 Jul 1. No abstract available.
- Chen C, Ni Q, Shi Y, Fu S, Pan X, Wang Y, Yang J, Wang R. Prognosis analysis of lobectomy and sublobar resection in patients >/=75 years old with pathological stage I invasive lung adenocarcinoma of </=3 cm: a propensity score matching-based analysis. Transl Cancer Res. 2019 Apr;8(2):574-582. doi: 10.21037/tcr.2019.03.18.
- Gao Y, Zhang H, Li Y, Wang D, Ma Y, Chen Q. Preoperative pulmonary function correlates with systemic inflammatory response and prognosis in patients with non-small cell lung cancer: results of a single-institution retrospective study. Oncotarget. 2017 Apr 18;8(16):27489-27501. doi: 10.18632/oncotarget.14225.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
December 8, 2025
First Submitted That Met QC Criteria
March 20, 2026
First Posted (Actual)
March 27, 2026
Study Record Updates
Last Update Posted (Actual)
March 27, 2026
Last Update Submitted That Met QC Criteria
March 20, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025z-179
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The confidentiality of all patient information was strictly ensured, and no participant data will be disclosed.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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