- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07659483
Cerebral Oximetry-Guided Low FiO2 Strategies in Thoracic Surgery.
16. juni 2026 opdateret af: Ayhan Kaydu, Dicle University
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ayhan Kaydu, associate professor
- Telefonnummer: +90 505 556 7939
- E-mail: akaydu@hotmail.com
Studiesteder
-
-
Eyalet/Yerleşke
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Diyarbakır, Eyalet/Yerleşke, Tyrkiet (Türkiye), 21070
- Dicle University
-
Kontakt:
- Ayhan Kaydu
- Telefonnummer: +90 505 556 7939
- E-mail: akaydu@hotmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Low FiO2 Group
Patients undergoing elective thoracic surgery managed with a cerebral oximetry-guided low FiO_2 ventilation strategy
|
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
|
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Aktiv komparator: Standard Group
Patients undergoing elective thoracic surgery managed with a standard conventional ventilation strategy
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Patients receive the standard institutional anesthesia protocol where $SpO_2$ values are strictly maintained above 90%
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Postoperative Delirium
Tidsramme: Postoperative days 1 to 3 (up to hospital discharge)
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Assessed using the 3D-CAM (Confusion Assessment Method) test
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Postoperative days 1 to 3 (up to hospital discharge)
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Incidence of Cerebral Desaturation
Tidsramme: Perioperative period (from anesthesia induction to end of surgery, approximately up to 4 hours)
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Cerebral desaturation monitored via near-infrared spectroscopy (rSO₂, %)
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Perioperative period (from anesthesia induction to end of surgery, approximately up to 4 hours)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Hypoxemia
Tidsramme: During one-lung ventilation (OLV), approximately up to 2 hours
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Incidence of hypoxemia defined as SpO₂ < 90% during one-lung ventilation (%)
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During one-lung ventilation (OLV), approximately up to 2 hours
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Mean Fraction of Inspired Oxygen (FiO₂)
Tidsramme: During one-lung ventilation (OLV), approximately up to 2 hours
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Mean FiO₂ levels required to maintain adequate oxygenation during one-lung ventilation
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During one-lung ventilation (OLV), approximately up to 2 hours
|
|
Mean Arterial Pressure (MAP)
Tidsramme: Intraoperative period, approximately up to 4 hours
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Intraoperative mean arterial pressure changes monitored via standard non-invasive or invasive blood pressure measurement (mmHg)
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Intraoperative period, approximately up to 4 hours
|
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Heart Rate (HR)
Tidsramme: Intraoperative period, approximately up to 4 hours
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Intraoperative heart rate changes monitored via standard ECG (beats per minute)
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Intraoperative period, approximately up to 4 hours
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
15. juni 2026
Primær færdiggørelse (Anslået)
1. august 2026
Studieafslutning (Anslået)
15. august 2026
Datoer for studieregistrering
Først indsendt
11. juni 2026
Først indsendt, der opfyldte QC-kriterier
16. juni 2026
Først opslået (Faktiske)
22. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 74/2026
Plan for individuelle deltagerdata (IPD)
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