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Lung CancerOLVNCT07494006

Spontaneous Breathing Mode: A Risk for Hypoxemia During OLV?

An observational study of Lung Cancer and OLV, run by Peking University People's Hospital at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, OLV, Hypoxemia During Surgery
How many people
44 participants
Where
1 siteChina
Study dates
15 Jul 2025to 31 Dec 2026
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who underwent thoracoscopic partial pulmonary resection at Peking University People's Hospital

Who may be able to join

  • Age ≥ 18 years
  • BMI > 18.5 and < 30
  • Informed consent obtained

Who cannot join

  • • Inability to use the EIT belt preoperatively
  • Failure to implement one-lung ventilation during surgery

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

  • Peking University People's Hospital

    Beijing, 100044

Other trials in China

About this study

Official title: 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.

Keywords
EIT, OLV, Hypoxemia, lung cancer
Medical subject headings
Lung Neoplasms, Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07494006
Study groupRoleWhat they receive
Ventilation-Matched GroupIn this patient group, the dependent lung exhibited better ventilation in the lateral decubitus position during spontaneous breathing than in the supine position.
Ventilation-Mismatched GroupIn 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lowest SpO₂ during OLV

    We will record the value of the lowest peripheral oxygen saturation (SpO₂) during intraoperative one-lung ventilation.

    Measured: Perioperative

Secondary outcomes (2)

  1. Postoperative functional status

    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.

    Measured: Follow-up assessments with both questionnaires were conducted at 6 and 12 months postoperatively.

  2. postoperative quality of life

    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.

    Measured: Follow-up assessments with both questionnaires were conducted at 6 and 12 months postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start15 Jul 2025
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07494006
Sponsor's protocol ID
2025z-179
Acronym
OLV
Status last verified
Jan 2026
First submitted
8 Dec 2025
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The confidentiality of all patient information was strictly ensured, and no participant data will be disclosed.

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.

    PubMed 21045639

  • 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.

    PubMed 8445433

  • 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.

    PubMed 8381294

  • 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.

    PubMed 39445936

  • 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.

    PubMed 38012186

  • 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.

    PubMed 38538496

  • 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.

    PubMed 39563476

  • 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.

    PubMed 37731718

  • 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.

    PubMed 38278058

  • 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.

    PubMed 40292239

  • 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.

    PubMed 37600211

  • 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.

    PubMed 35116790

  • 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.

    PubMed 28039482

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer and OLV, 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 3 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 27 Mar 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lowest SpO₂ during OLV (time frame: Perioperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07494006, which also lists 13 linked publications.

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 27 Mar 2026.

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