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Not yet recruiting NCT07381517

Correlation of Oxygenation and Saturation Indices in One-Lung Ventilation

Observational One-lung Ventilation (OLV)

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: One-lung Ventilation (OLV). 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
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Correlation Between Oxygenation Indices (OI and Their Derivatives) and Oxygen Saturation Indices (OSI and Their Derivatives) During One-Lung Ventilation in Thoracic Surgery

Overview

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.

Detailed description

One-lung ventilation induces complex changes in pulmonary physiology, including increased intrapulmonary shunt and altered respiratory mechanics, which may challenge conventional approaches to intraoperative oxygenation assessment. While invasive oxygenation indices are widely used, their applicability during one-lung ventilation is limited by the need for arterial blood gas sampling and the lack of integration of mechanical ventilation-related stress.

Non-invasive oxygen saturation-based indices have been proposed as alternatives; however, data regarding their performance under the dynamic physiological conditions of one-lung ventilation remain scarce. Furthermore, emerging concepts in lung-protective ventilation emphasize the importance of driving pressure and mechanical power as determinants of ventilator-induced lung injury, yet these parameters are not incorporated into traditional oxygenation metrics.

In this prospective observational study, invasive and non-invasive oxygenation indices, including modified forms incorporating driving pressure and mechanical power, will be recorded simultaneously during one-lung ventilation in adult patients undergoing elective thoracic surgery. The relationships and agreement between these indices will be analyzed to assess their comparability across different levels of mechanical respiratory load.

No intervention beyond standard clinical care will be applied. Ventilatory settings and perioperative management will be determined solely by routine clinical practice. This study is designed to provide methodological insight into the intraoperative applicability of non-invasive oxygenation indices during one-lung ventilation.

Primary outcome measures

  • Correlation between oxygenation indices and oxygen saturation indices [Time frame: During intraoperative one-lung ventilation]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

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

Turkey (Türkiye) · 1 center
  • Ankara Ataturk Sanatoryum Education and Research Hospital — Ankara

Publications

  • 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. PMID 38179691
  • 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. PMID 18451319
  • 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. PMID 25693014

Identifiers

NCT: NCT07381517 · OLV-OXY-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗