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Enrolling by invitation NCT07494006

Spontaneous Breathing Mode: A Risk for Hypoxemia During OLV?

— Observational Lung Cancer OLV Hypoxemia During Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Lung Cancer, OLV, Hypoxemia During Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Association Between Spontaneous Breathing Mode and Hypoxemia During One-Lung Ventilation Under General Anesthesia

Overview

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.

Primary outcome measures

  • Lowest SpO₂ during OLV [Time frame: Perioperative]
Secondary outcome measures (2)
  • Postoperative functional status [Time frame: Follow-up assessments with both questionnaires were conducted at 6 and 12 months postoperatively.]
  • postoperative quality of life [Time frame: Follow-up assessments with both questionnaires were conducted at 6 and 12 months postoperatively.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Peking University People's Hospital — Beijing

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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, PMID 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. PMID 37731718

Identifiers

NCT: NCT07494006 · 2025z-179

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗