ORI-Guided Oxygen Therapy During One-Lung Ventilation (ORI-OLV)
17 juli 2026 bijgewerkt door: Tae-Yop Kim, MD PhD, Konkuk University Medical Center
Effect of Oxygen Reserve Index-Guided Fraction of Inspired Oxygen Titration on the Incidence of Hyperoxemia During One-Lung Ventilation
High inspired oxygen concentrations (FiO₂) are commonly administered during general anesthesia to prevent hypoxemia. However, excessive oxygen administration may result in hyperoxemia, which has been associated with impaired hypoxic pulmonary vasoconstriction, increased oxidative stress, ventilation-perfusion mismatch, and postoperative pulmonary complications.
During one-lung ventilation (OLV) for thoracic surgery, higher FiO₂ is often required because of increased intrapulmonary shunting, making hyperoxemia a frequent occurrence. The Oxygen Reserve Index (ORI) is a noninvasive pulse oximetry-derived parameter that reflects moderate hyperoxemia (PaO₂ approximately 100-200 mmHg) and may facilitate more precise oxygen titration than pulse oximetry alone.
Studie Overzicht
Toestand
Nog niet aan het werven
Interventie / Behandeling
Gedetailleerde beschrijving
This prospective, randomized, assessor-blinded clinical trial aims to determine whether FiO₂ titration guided by both ORI and peripheral oxygen saturation (SpO₂) reduces the incidence of hyperoxemia compared with conventional SpO₂-guided FiO₂ titration during OLV in patients undergoing thoracic surgery.
Participants will be randomly assigned to either an ORI-guided group or a conventional SpO₂-guided group.
The primary outcome is the incidence of hyperoxemia (PaO₂ >125 mmHg) after OLV.
Secondary outcomes include SpO₂, ORI, PaO₂, and FiO₂ measured
Studietype
Ingrijpend
Inschrijving (Geschat)
58
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Tae-Yop Kim
- Telefoonnummer: 82-10-8811-6942
- E-mail: taeyop@gmail.com
Studie Contact Back-up
- Naam: Chungsik Oh
- E-mail: iamchungsik@daum.net
Studie Locaties
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Gwangjin-gu
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Seoul, Gwangjin-gu, Zuid -Korea, 05030
- Konkuk University Medical Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Adults aged ≥19 years
- Scheduled for elective lung surgery requiring one-lung ventilation
- Written informed consent
Exclusion Criteria:
- Severe pulmonary hypertension.
- Left ventricular systolic dysfunction.
Withdrawal Criteria:
- The participant or legally authorized representative requests withdrawal from the study.
- An adverse event occurs that precludes continued participation in the study.
- The planned surgery or study procedures are not performed (e.g., ORI monitoring is not applied or arterial blood gas analysis is not performed).
- Perfusion Index is less than 2 during the study.
- A major violation of the inclusion or exclusion criteria is identified after enrollment.
- The participant fails to comply with the study protocol, potentially affecting the validity of the study outcomes.
- Continued participation is considered not to be in the participant's best interest.
- In the investigator's judgment, any other condition arises that makes continued participation inappropriate.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: ORI-Guided FiO2 Titration
Fraction of inspired oxygen (FiO₂) is titrated using both the Oxygen Reserve Index (ORI) and peripheral oxygen saturation (SpO₂) during one-lung ventilation.
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During one-lung ventilation, FiO₂ is adjusted according to both ORI and SpO₂.
FiO₂ is titrated to maintain SpO₂ ≥98% while keeping ORI above 0 to minimize hyperoxemia.
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Actieve vergelijker: Conventional SpO₂-Guided FiO₂ Titration
Fraction of inspired oxygen (FiO₂) is titrated using peripheral oxygen saturation (SpO₂) alone according to the institutional standard of care during one-lung ventilation.
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During one-lung ventilation, FiO₂ is adjusted according to SpO₂ alone.
FiO₂ is titrated to maintain SpO₂ ≥98% according to the institutional standard of care.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Incidence of hyperoxemia during one-lung ventilation
Tijdsspanne: 10 min after initiation of one-lung ventilation during operation
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Hyperoxemia is defined as an arterial partial pressure of oxygen (PaO₂) greater than 125 mmHg measured after initiation of one-lung ventilation.
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10 min after initiation of one-lung ventilation during operation
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Peripheral oxygen saturation (SpO₂)
Tijdsspanne: 10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time
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Peripheral oxygen saturation
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10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time
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Oxygen Reserve Index (ORI)
Tijdsspanne: 10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time
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Oxygen Reserve Index measured during anesthesia.
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10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time
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Arterial oxygen tension (PaO₂)
Tijdsspanne: 10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time
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Arterial partial pressure of oxygen measured by arterial blood gas analysis.
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10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time
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Fraction of inspired oxygen (FiO₂)
Tijdsspanne: 10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time
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Fraction of inspired oxygen administered during anesthesia.
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10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time
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Medewerkers en onderzoekers
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Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 augustus 2026
Primaire voltooiing (Geschat)
30 april 2028
Studie voltooiing (Geschat)
30 april 2028
Studieregistratiedata
Eerst ingediend
2 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
17 juli 2026
Eerst geplaatst (Werkelijk)
22 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
22 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
17 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- KUMC 2026-05-061
Plan Individuele Deelnemersgegevens (IPD)
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NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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