NCT07494006

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jul 2025Dec 2026

Study Start

First participant enrolled

July 15, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

March 27, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

December 8, 2025

Last Update Submit

March 20, 2026

Conditions

Keywords

EITOLVHypoxemialung cancer

Outcome Measures

Primary Outcomes (1)

  • Lowest SpO₂ during OLV

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

    Perioperative

Secondary Outcomes (2)

  • Postoperative functional status

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

  • postoperative quality of life

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

Study Arms (2)

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.

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

Location

Related Publications (13)

  • 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.

    PMID: 21045639BACKGROUND
  • 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.

    PMID: 8445433BACKGROUND
  • 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.

    PMID: 8381294BACKGROUND
  • 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.

    PMID: 39445936BACKGROUND
  • 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.

    PMID: 38012186BACKGROUND
  • 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.

    PMID: 38538496BACKGROUND
  • 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.

    PMID: 39563476BACKGROUND
  • 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.

    PMID: 37731718BACKGROUND
  • 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.

    PMID: 38278058BACKGROUND
  • 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.

    PMID: 40292239BACKGROUND
  • 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.

    PMID: 37600211BACKGROUND
  • 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.

    PMID: 35116790BACKGROUND
  • 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.

    PMID: 28039482BACKGROUND

MeSH Terms

Conditions

Lung NeoplasmsHypoxia

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Anesthesiology

Study Record Dates

First Submitted

December 8, 2025

First Posted

March 27, 2026

Study Start

July 15, 2025

Primary Completion

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

The confidentiality of all patient information was strictly ensured, and no participant data will be disclosed.

Locations