Thoracic SurgeryNCT07659483
Cerebral Oximetry-Guided Low FiO2 Strategies in Thoracic Surgery.
A study testing Standard High $FiO_2$ Strategy and Guided Low $FiO_2$ Strategy in people with Thoracic Surgery and Anesthesia, run by Dicle University at 1 site in Turkey (Türkiye).
Trial summary
Brief Summary (Kısa Özet)The purpose of this study is to evaluate the safety and efficacy of a cerebral oximetry-guided low fraction of inspired oxygen (FiO_2) ventilation strategy compared to a standard high FiO_2 strategy in patients undergoing elective thoracic surgery requiring one-lung ventilation (OLV).Oxygen… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, Anesthesia
- What is being tested?
- Standard High $FiO_2$ Strategy and Guided Low $FiO_2$ Strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2026to 15 Aug 2026
- Phase
- Interventional
- 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
Who may be able to join
- Patients aged 18 years or older. Scheduled for elective thoracic surgery requiring one-lung ventilation (OLV). American Society of Anesthesiologists (ASA) Physical Status classification I-III.
Who cannot join
- History of cerebrovascular disease. Left ventricular ejection fraction Pulmonary hypertension. Interstitial lung disease.
- Renal failure. Neuromuscular disease. Pregnancy. Expected OLV duration less than 30 minutes (< 30 min)
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
Dicle University
Diyarbakır, Eyalet/Yerleşke, 21070
Ayhan Kaydu, +90 505 556 7939, akaydu@hotmail.com
About this study
Official title: Safety and Efficacy of Cerebral Oximetry-Guided Low FiO2 Strategies in Thoracic Surgery
Brief Summary (Kısa Özet)The purpose of this study is to evaluate the safety and efficacy of a cerebral oximetry-guided low fraction of inspired oxygen (FiO_2) ventilation strategy compared to a standard high FiO_2 strategy in patients undergoing elective thoracic surgery requiring one-lung ventilation (OLV).Oxygen toxicity and related postoperative pulmonary complications remain significant risks during thoracic anesthesia. While standard protocols often rely on high inspired oxygen concentrations to maintain peripheral oxygen saturation (SpO_2), this approach may induce hyperoxia. Conversely, lowering FiO_2 arbitrarily can increase the risk of hypoxemia or compromise tissue oxygenation. This prospective, parallel-group, 1:1 randomized, single-blind clinical trial aims to safely reduce intraoperative oxygen exposure by using regional cerebral oxygen saturation (rSO_2) monitoring as a physiological guide.A total of 60 participants aged 18 and older, classified as ASA I-III and scheduled for elective thoracic surgery, will be randomly assigned to one of two arms:Experimental Group (Guided Low FiO_2 Strategy): Ventilation will be initiated at a low FiO_2 of 0.5. The FiO_2 level will not be increased unless peripheral saturation (SpO_2) falls below 90% or cerebral oxygenation (rSO_2) drops below 80% of the patient's baseline value.Active Comparator Group (Standard Strategy): Patients will receive conventional anesthesia management, maintaining standard high FiO_2 levels to keep SpO_2 above 90% without cerebral oximetry guidance.The primary outcomes to be measured are the incidence of cerebral desaturation during the perioperative period and the incidence of postoperative delirium assessed via the 3D-CAM tool until hospital discharge. Secondary outcomes include intraoperative hemodynamic stability, arterial blood gas parameters (PaO_2, PaCO_2, pH, lactate), incidence of hypoxemia, total one-lung ventilation duration, postoperative cognitive dysfunction (POCD), and lengths of stay in both the intensive care unit (ICU) and the hospital.By utilizing real-time non-invasive cerebral oximetry, the study intends to demonstrate a safe ventilation protocol that minimizes oxygen toxicity without compromising cerebral oxygenation or clinical recovery outcomes.
- Conditions
- Thoracic Surgery, Anesthesia
- Being tested
- Standard High $FiO_2$ Strategy, Guided Low $FiO_2$ Strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard High $FiO_2$ StrategyProcedure or surgery
Patients receive the standard institutional anesthesia protocol where $SpO_2$ values are strictly maintained above 90%
Guided Low $FiO_2$ StrategyProcedure or surgery
Following general anesthesia induction, the initial $FiO_2$ will be set to 0.5. $FiO_2$ will not be increased unless the patient's pulse oximetry ($SpO_2$) drops below 90% or regional cerebral oxygen saturation ($rSO_2$) drops below 80% of its baseline value
| Study group | Role | What they receive |
|---|---|---|
| Low FiO2 Group | Experimental | Patients undergoing elective thoracic surgery managed with a cerebral oximetry-guided low FiO_2 ventilation strategy Receives: Procedure: Guided Low $FiO_2$ Strategy |
| Standard Group | Active comparator | Patients undergoing elective thoracic surgery managed with a standard conventional ventilation strategy Receives: Procedure: Standard High $FiO_2$ Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Delirium
Assessed using the 3D-CAM (Confusion Assessment Method) test
Measured: Postoperative days 1 to 3 (up to hospital discharge)
Incidence of Cerebral Desaturation
Cerebral desaturation monitored via near-infrared spectroscopy (rSO₂, %)
Measured: Perioperative period (from anesthesia induction to end of surgery, approximately up to 4 hours)
Secondary outcomes (4)
Incidence of Hypoxemia
Incidence of hypoxemia defined as SpO₂ < 90% during one-lung ventilation (%)
Measured: During one-lung ventilation (OLV), approximately up to 2 hours
Mean Fraction of Inspired Oxygen (FiO₂)
Mean FiO₂ levels required to maintain adequate oxygenation during one-lung ventilation
Measured: During one-lung ventilation (OLV), approximately up to 2 hours
Mean Arterial Pressure (MAP)
Intraoperative mean arterial pressure changes monitored via standard non-invasive or invasive blood pressure measurement (mmHg)
Measured: Intraoperative period, approximately up to 4 hours
Heart Rate (HR)
Intraoperative heart rate changes monitored via standard ECG (beats per minute)
Measured: Intraoperative period, approximately up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dicle University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayhan Kaydu, Dicle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659483
- Sponsor's protocol ID
- 74/2026
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Cerebral Oximetry-Guided Low FiO2 Strategies in Thoracic Surgery
- ClinicalTrials.gov ID
- NCT07659483
- Acronym / sponsor ID
- 74/2026
- Conditions
- Thoracic Surgery, Anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dicle UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 22 Jun 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.
Brief Summary (Kısa Özet)The purpose of this study is to evaluate the safety and efficacy of a cerebral oximetry-guided low fraction of inspired oxygen (FiO_2) ventilation strategy compared to a standard high FiO_2 strategy in patients undergoing elective thoracic surgery requiring one-lung ventilation (OLV).Oxygen toxicity and related postoperative pulmonary complications remain significant risks during thoracic anesthesia. While standard protocols often rely on high inspired oxygen concentrations to maintain peripheral oxygen saturation (SpO_2), this approach may induce hyperoxia. Conversely, lowering FiO_2 arbitrarily can increase the risk of hypoxemia or compromise tissue oxygenation. This prospective, parallel-group, 1:1 randomized, single-blind clinical trial aims to safely reduce intraoperative oxygen exposure by using regional cerebral oxygen saturation (rSO_2) monitoring as a physiological guide.A total of 60 participants aged 18 and older, classified as ASA I-III and scheduled for elective thoracic surgery, will be randomly assigned to one of two arms:Experimental Group (Guided Low FiO_2 Strategy): Ventilation will be initiated at a low FiO_2 of 0.5. The FiO_2 level will not be increased unless peripheral saturation (SpO_2) falls below 90% or cerebral oxygenation (rSO_2) drops below 80% of the patient's baseline value.Active Comparator Group (Standard Strategy): Patients will receive conventional anesthesia management, maintaining standard high FiO_2 levels to keep SpO_2 above 90% without cerebral oximetry guidance.The primary outcomes to be measured are the incidence of cerebral desaturation during the perioperative period and the incidence of postoperative delirium assessed via the 3D-CAM tool until hospital discharge. Secondary outcomes include intraoperative hemodynamic stability, arterial blood gas parameters (PaO_2, PaCO_2, pH, lactate), incidence of hypoxemia, total one-lung ventilation duration, postoperative cognitive dysfunction (POCD), and lengths of stay in both the intensive care unit (ICU) and the hospital.By utilizing real-time non-invasive cerebral oximetry, the study intends to demonstrate a safe ventilation protocol that minimizes oxygen toxicity without compromising cerebral oxygenation or clinical recovery outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low FiO2 Group | Experimental | Procedure: Guided Low $FiO_2$ StrategyPatients undergoing elective thoracic surgery managed with a cerebral oximetry-guided low FiO_2 ventilation strategy |
| Standard Group | Active comparator | Procedure: Standard High $FiO_2$ StrategyPatients undergoing elective thoracic surgery managed with a standard conventional ventilation strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 years or older. Scheduled for elective thoracic surgery requiring one-lung ventilation (OLV). American Society of Anesthesiologists (ASA) Physical Status classification I-III.
Key exclusion criteria (2 listed)
- History of cerebrovascular disease. Left ventricular ejection fraction Pulmonary hypertension. Interstitial lung disease.
- Renal failure. Neuromuscular disease. Pregnancy. Expected OLV duration less than 30 minutes (< 30 min)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard High $FiO_2$ StrategyPatients receive the standard institutional anesthesia protocol where $SpO_2$ values are strictly maintained above 90% | Procedure or surgery | Standard Group |
| Guided Low $FiO_2$ StrategyFollowing general anesthesia induction, the initial $FiO_2$ will be set to 0.5. $FiO_2$ will not be increased unless the patient's pulse oximetry ($SpO_2$) drops below 90% or regional cerebral oxygen saturation ($rSO_2$) drops below 80% of its baseline value | Procedure or surgery | Low FiO2 Group |
Primary outcome
Incidence of Postoperative Delirium
Time frame: Postoperative days 1 to 3 (up to hospital discharge)
Assessed using the 3D-CAM (Confusion Assessment Method) test
Incidence of Cerebral Desaturation
Time frame: Perioperative period (from anesthesia induction to end of surgery, approximately up to 4 hours)
Cerebral desaturation monitored via near-infrared spectroscopy (rSO₂, %)
4 secondary outcomes
Incidence of Hypoxemia
Time frame: During one-lung ventilation (OLV), approximately up to 2 hours
Mean Fraction of Inspired Oxygen (FiO₂)
Time frame: During one-lung ventilation (OLV), approximately up to 2 hours
Mean Arterial Pressure (MAP)
Time frame: Intraoperative period, approximately up to 4 hours
Heart Rate (HR)
Time frame: Intraoperative period, approximately up to 4 hours
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 22 Jun 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard High $FiO_2$ Strategy and Guided Low $FiO_2$ Strategy in people with Thoracic Surgery and Anesthesia, run by Dicle University 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 1 inclusion and 2 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 22 Jun 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?
Contact Ayhan Kaydu, associate professor (+90 505 556 7939, akaydu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Delirium (time frame: Postoperative days 1 to 3 (up to hospital discharge)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2026.