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NCT Number: NCT07659483

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

Standard High $FiO_2$ Strategy

Procedure

Patients receive the standard institutional anesthesia protocol where $SpO_2$ values are strictly maintained above 90%

Guided Low $FiO_2$ Strategy

Procedure

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

Primary outcomes

  1. Incidence of Postoperative Delirium

    Time frame: Postoperative days 1 to 3 (up to hospital discharge)

    Assessed using the 3D-CAM (Confusion Assessment Method) test

  2. 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, %)

Secondary outcomes

  1. Incidence of Hypoxemia

    Time frame: During one-lung ventilation (OLV), approximately up to 2 hours

    Incidence of hypoxemia defined as SpO₂ < 90% during one-lung ventilation (%)

  2. Mean Fraction of Inspired Oxygen (FiO₂)

    Time frame: During one-lung ventilation (OLV), approximately up to 2 hours

    Mean FiO₂ levels required to maintain adequate oxygenation during one-lung ventilation

  3. Mean Arterial Pressure (MAP)

    Time frame: Intraoperative period, approximately up to 4 hours

    Intraoperative mean arterial pressure changes monitored via standard non-invasive or invasive blood pressure measurement (mmHg)

  4. Heart Rate (HR)

    Time frame: Intraoperative period, approximately up to 4 hours

    Intraoperative heart rate changes monitored via standard ECG (beats per minute)

Study contacts

Contact information is provided by the study sponsor or research team.

Ayhan Kaydu, associate professor

CONTACT

[email protected]

+90 505 556 7939

Sponsors and collaborators

Lead sponsor

Dicle University

Other

Registry information

Official study title

Safety and Efficacy of Cerebral Oximetry-Guided Low FiO2 Strategies in Thoracic Surgery

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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