- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07679724
Evaluation of Oxygen Reserve Index (ORi) in Obese and Non-Obese Patients Over 65 Years Old
30. juni 2026 opdateret af: Çağla TUNCEL, Ankara City Hospital Bilkent
Evaluation of Oxygen Reserve Index (ORi) in Obese and Non-Obese Patients Over 65 Years Old Scheduled for Elective Surgery Under General Anesthesia
After obtaining ethical committee approval, this single-center, prospective, observational study included volunteer patients of both sexes, aged 65 years and older, with ASA II-III risk scores, who were scheduled for elective surgery with endotracheal intubation under general anesthesia (GAA).
90 patients were divided into two groups: those with normal BMI (19 < BMI < 25 kg/m² (GROUP 1)) and those who were obese (30 < BMI < 40 kg/m² (GROUP 2)).
In addition to standard ASA monitoring, a finger sensor (Rainbow® SET, Masimo Inc., Irvine, Ca., USA) was implanted for ORi measurement, and baseline values were recorded.
Patients were preoxygenated until EtO2 (endtidal oxygen) concentration reached at least 85%.
After ORi reached a plateau level, general anesthesia was induced and endotracheal intubation was performed.
After confirming the tube's position, the breathing circuit was disconnected from the endotracheal tube, and patients were allowed to be apneic until SpO2 reached 94%.
Throughout this process, patients' other vital signs, SpO₂, and ORi were continuously monitored.
The time elapsed when ORi triggered an alarm, when SpO2 reached 97%, and when SpO2 reached 94% was recorded.
The 'ORi warning time', 'SpO2 warning time', and the 'additional warning time provided by ORi' (the difference between 'ORi warning time' and 'SpO2 warning time') were recorded.
Studieoversigt
Status
Afsluttet
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
90
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Ankara, Tyrkiet (Türkiye)
- Ankara Bilkent City Hospital
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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
- Ældre voksen
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
90 patients aged 65 and over, ASA II-III
Beskrivelse
Inclusion Criteria:
Patients of both sexes aged 65 years and older with ASA II-III risk scores who are scheduled to undergo elective surgical procedures with endotracheal intubation under general anesthesia.
Exclusion Criteria:
- Patients under 65 years of age
- Patients with heart and lung disease
- Patients in situations where the patient is unable to cooperate (e.g., dementia, Alzheimer's)
- Patients suspected of having airway difficulties
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Group 1
Patients with normal BMI (19 < BMI < 25 kg/m²)
|
|
Group 2
Obese patients (30 < BMI < 40 kg/m² )
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Oxygen reserve index (ORi) warning time, SpO2 warning time, and added warning time defined as the difference between the two
Tidsramme: 15 minutes after preoxygenation
|
The primary aim of this study was to determine whether ORi provides an early warning of impending desaturation compared to pulse oximetry in both obese (30 < BMI < 40 kg/m²) and normal body mass index (19 < BMI < 25 kg/m²) patients over 65 years of age scheduled for elective surgery will be assesed until SpO2 drops to 94%
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15 minutes after preoxygenation
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Oxygen reserve index (ORi) warning time, SpO2 warning time, and added warning time defined as the difference between the two
Tidsramme: 15 minutes after preoxygenation
|
The secondary objective of this study was to compare the additional stimulus duration provided by ORi in obese (30 < BMI < 40 kg/m²) and normal body mass index (19 < BMI < 25 kg/m²) patients over 65 years of age will be assesed until SpO2 drops to 94%
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15 minutes after preoxygenation
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Fleming NW, Singh A, Lee L, Applegate RL 2nd. Oxygen Reserve Index: Utility as an Early Warning for Desaturation in High-Risk Surgical Patients. Anesth Analg. 2021 Mar 1;132(3):770-776. doi: 10.1213/ANE.0000000000005109.
- Tsymbal E, Ayala S, Singh A, Applegate RL 2nd, Fleming NW. Study of early warning for desaturation provided by Oxygen Reserve Index in obese patients. J Clin Monit Comput. 2021 Aug;35(4):749-756. doi: 10.1007/s10877-020-00531-w. Epub 2020 May 18.
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 (Faktiske)
1. november 2023
Primær færdiggørelse (Faktiske)
1. maj 2024
Studieafslutning (Faktiske)
1. juli 2024
Datoer for studieregistrering
Først indsendt
2. maj 2026
Først indsendt, der opfyldte QC-kriterier
30. juni 2026
Først opslået (Faktiske)
1. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AnkaraCHBilkent-AR-CT-01
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
I will share the parameters and results of the study.
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