NCT07381517

Brief Summary

One-lung ventilation is commonly used during thoracic surgery but is frequently associated with impaired oxygenation and altered respiratory mechanics. Traditional oxygenation indices require arterial blood gas analysis and do not fully reflect the mechanical stress applied to the lungs. This prospective observational study aims to evaluate the correlation between oxygenation indices and oxygen saturation indices during one-lung ventilation in adult patients undergoing elective thoracic surgery. Modified indices incorporating driving pressure and mechanical power will also be assessed. No intervention beyond standard clinical care will be applied. The findings of this study may help clarify the clinical utility of non-invasive oxygenation indices for intraoperative monitoring during one-lung ventilation.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
3mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress49%
Feb 2026Aug 2026

First Submitted

Initial submission to the registry

January 25, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

February 9, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2026

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

January 25, 2026

Last Update Submit

January 25, 2026

Conditions

Keywords

One-Lung VentilationOxygenationOxygen Saturation IndexDriving PressureMechanic PowerThoracic Surgery

Outcome Measures

Primary Outcomes (1)

  • Correlation between oxygenation indices and oxygen saturation indices

    Correlation between invasive oxygenation indices (oxygenation index and its derivatives) and non-invasive oxygen saturation indices (oxygen saturation index and its derivatives) measured during one-lung ventilation.

    During intraoperative one-lung ventilation

Study Arms (1)

One-Lung Ventilation Cohort

Adult patients undergoing elective thoracic surgery requiring one-lung ventilation. All patients will be managed according to standard clinical practice. No intervention is assigned as part of this observational study.

Eligibility Criteria

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

Adult patients aged 18 years and older with ASA physical status I-III who are scheduled for elective thoracic surgery requiring intraoperative one-lung ventilation for at least one hour. All participants undergo standard perioperative management with simultaneous arterial blood gas analysis and continuous pulse oximetry monitoring during surgery.

You may qualify if:

  • Patients aged 18 years and older
  • Patients classified as ASA physical status I-III
  • Patients scheduled for elective thoracic surgery requiring one-lung ventilation for at least 1 hour intraoperatively
  • Patients in whom simultaneous arterial blood gas analysis and continuous SpO₂ monitoring can be performed
  • Patients who have provided written informed consent

You may not qualify if:

  • Patients undergoing emergency surgery
  • Patients younger than 18 years of age
  • Patients classified as ASA physical status IV or higher
  • Patients with a history of previous thoracic surgery
  • Patients with a body mass index (BMI) \>40 kg/m² or \<18 kg/m²
  • Patients with advanced chronic lung disease (COPD stage III-IV)
  • Patients with New York Heart Association (NYHA) class III-IV heart failure
  • Patients undergoing surgery due to pleural effusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Ataturk Sanatoryum Education and Research Hospital

Ankara, 06290, Turkey (Türkiye)

Location

Related Publications (3)

  • Asar S, Rahim F, Rahimi P, Acicbe O, Tontu F, Cukurova Z. Novel Oxygenation and Saturation Indices for Mortality Prediction in COVID-19 ARDS Patients: The Impact of Driving Pressure and Mechanical Power. J Intensive Care Med. 2024 Jun;39(6):595-608. doi: 10.1177/08850666231223498. Epub 2024 Jan 5.

  • Chiumello D, Carlesso E, Cadringher P, Caironi P, Valenza F, Polli F, Tallarini F, Cozzi P, Cressoni M, Colombo A, Marini JJ, Gattinoni L. Lung stress and strain during mechanical ventilation for acute respiratory distress syndrome. Am J Respir Crit Care Med. 2008 Aug 15;178(4):346-55. doi: 10.1164/rccm.200710-1589OC. Epub 2008 May 1.

  • Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.

Related Links

Study Officials

  • Onur KARSLIOĞLU

    Ankara Ataturk Sanatorium Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician in Anesthesiology

Study Record Dates

First Submitted

January 25, 2026

First Posted

February 2, 2026

Study Start

February 9, 2026

Primary Completion (Estimated)

June 9, 2026

Study Completion (Estimated)

August 9, 2026

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Informed Consent Form Access

Locations