- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07381517
Correlation of Oxygenation and Saturation Indices in One-Lung Ventilation (OLV-INDICES)
Correlation Between Oxygenation Indices (OI and Their Derivatives) and Oxygen Saturation Indices (OSI and Their Derivatives) During One-Lung Ventilation in Thoracic Surgery
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Ankara, Turkey (Türkiye), 06290
- Ankara Ataturk Sanatoryum Education and Research Hospital
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Contact:
- ONUR KARSLIOĞLU
- Phone Number: +09-539-894-7542
- Email: dronuralperen@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Correlation between oxygenation indices and oxygen saturation indices
Time Frame: During intraoperative one-lung ventilation
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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.
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During intraoperative one-lung ventilation
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Collaborators and Investigators
Investigators
- Principal Investigator: Onur KARSLIOĞLU, ANKARA ATATURK SANATORİUM TRAİNİNG AND RESEARCH HOSPITAL
Publications and helpful links
General Publications
- 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.
- 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.
- Lohmann T, Nietzschmann U, Kiess W. "Lady-like": is there a latent autoimmune diabetes in the young? Diabetes Care. 2000 Nov;23(11):1707-8. doi: 10.2337/diacare.23.11.1707. No abstract available.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- OLV-OXY-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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