One-lung Ventilation (OLV)OLV-INDICESNCT07381517
Correlation of Oxygenation and Saturation Indices in One-Lung Ventilation
An observational study of One-lung Ventilation (OLV), run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- One-lung Ventilation (OLV)
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Feb 2026to 9 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Ataturk Sanatoryum Education and Research Hospital
Ankara, 06290
ONUR KARSLIOĞLU, +09-539-894-7542, dronuralperen@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- One-lung Ventilation (OLV)
- Keywords
- One-Lung Ventilation, Oxygenation, Oxygen Saturation Index, Driving Pressure, Mechanic Power, Thoracic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During intraoperative one-lung ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start9 Feb 2026 (estimated)
- Primary completion9 Jun 2026 (estimated)
- Study completion9 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for One-lung Ventilation (OLV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Onur KARSLIOĞLU, Ankara Ataturk Sanatorium Training and Research Hospital
- Investigators
- Onur KARSLIOĞLU, Principal investigator, Ankara Ataturk Sanatorium Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381517
- Sponsor's protocol ID
- OLV-OXY-001
- Acronym
- OLV-INDICES
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38179691Chiumello 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.
PubMed 18451319Amato 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.
PubMed 25693014
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07381517
- Acronym / sponsor ID
- OLV-INDICES / OLV-OXY-001
- Conditions
- One-lung Ventilation (OLV)
- Keywords
- One-Lung Ventilation, Oxygenation, Oxygen Saturation Index, Driving Pressure, Mechanic Power, Thoracic Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Study start
- 9 Feb 2026 (estimated)
- Primary completion
- 9 Jun 2026 (estimated)
- Study completion
- 9 Aug 2026 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between oxygenation indices and oxygen saturation indices
Time frame: During intraoperative one-lung ventilation
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Results publication: PubMed 38179691Asar 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.
- Results publication: PubMed 18451319Chiumello 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.
- Results publication: PubMed 25693014Amato 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.
- Ankara Atatürk Sanatoryum Training and Research HospitalLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ankara Ataturk Sanatoryum Education and Research Hospital
Ankara, Turkey (Türkiye)
Onur KARSLIOĞLU principal investigator
Ankara Ataturk Sanatorium Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of One-lung Ventilation (OLV), run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between oxygenation indices and oxygen saturation indices (time frame: During intraoperative one-lung ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07381517, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.