ORI-Guided Oxygen Therapy During One-Lung Ventilation (ORI-OLV)
17 juli 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Interventionell
Inskrivning (Beräknad)
58
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Tae-Yop Kim
- Telefonnummer: 82-10-8811-6942
- E-post: taeyop@gmail.com
Studera Kontakt Backup
- Namn: Chungsik Oh
- E-post: iamchungsik@daum.net
Studieorter
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Gwangjin-gu
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Seoul, Gwangjin-gu, Sydkorea, 05030
- Konkuk University Medical Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Aktiv komparator: 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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Aktiv komparator: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Incidence of hyperoxemia during one-lung ventilation
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Peripheral oxygen saturation (SpO₂)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 augusti 2026
Primärt slutförande (Beräknad)
30 april 2028
Avslutad studie (Beräknad)
30 april 2028
Studieregistreringsdatum
Först inskickad
2 juli 2026
Först inskickad som uppfyllde QC-kriterierna
17 juli 2026
Första postat (Faktisk)
22 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KUMC 2026-05-061
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