ORI-Guided Oxygen Therapy During One-Lung Ventilation (ORI-OLV)
17. juli 2026 oppdatert 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
58
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Tae-Yop Kim
- Telefonnummer: 82-10-8811-6942
- E-post: taeyop@gmail.com
Studer Kontakt Backup
- Navn: Chungsik Oh
- E-post: iamchungsik@daum.net
Studiesteder
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Gwangjin-gu
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Seoul, Gwangjin-gu, Sør -Korea, 05030
- Konkuk University Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of hyperoxemia during one-lung ventilation
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Peripheral oxygen saturation (SpO₂)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. august 2026
Primær fullføring (Antatt)
30. april 2028
Studiet fullført (Antatt)
30. april 2028
Datoer for studieregistrering
Først innsendt
2. juli 2026
Først innsendt som oppfylte QC-kriteriene
17. juli 2026
Først lagt ut (Faktiske)
22. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KUMC 2026-05-061
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