NCT07119866

Brief Summary

Background: The Oxygen Reserve Index (ORI) is a non-invasive parameter utilizing multi-wavelength pulse co-oximetry. ORI can provide early warnings of deteriorating oxygenation before changes are reflected in SpO₂ levels. This study aimed to investigate the feasibility of non-ventilated intubation in patients undergoing cholecystectomy as a means to achieve safe intubation without nasogastric tube placement, with reduced trauma and cost, and improved time efficiency.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

August 7, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2025

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

14 days

First QC Date

July 21, 2025

Last Update Submit

August 6, 2025

Conditions

Oxygen Reserve IndexApneaVentilationBody Mass Index

Outcome Measures

Primary Outcomes (1)

  • TIME FOR ORI TO FALL BELOW 0.24

    TIME THE PATIENT STARTED TO WEAR A MASKS.

    WITHIN 10 MINUTES BEFORE INTUBATION

Secondary Outcomes (9)

  • INITIAL ORI VALUE

    WITHIN 10 MINUTES BEFORE INTUBATION

  • ORI VALUE AT 2 MINUTES

    WITHIN 10 MINUTES BEFORE INTUBATION

  • AGE

    WITHIN 10 MINUTES BEFORE INTUBATION

  • American Society of Anesthesiologists (ASA) Score

    WITHIN 10 MINUTES BEFORE INTUBATION

  • SEX

    WITHIN 10 MINUTES BEFORE INTUBATION

  • +4 more secondary outcomes

Study Arms (2)

ORI>0.24

Patients, aged between 18 and 60 years, classified as ASA physical status I-II,and with a Mallampati score \<2, were enrolled.On the day of surgery, following identity verification and confirmation of the surgical site, patients were positioned on a warmed operating table.Standard monitoring was applied, including ECG, SBP and DBP, SpO₂, and the ORI.Preoxygenation was achieved by administering 100% oxygen via 8 deep breaths over 60 seconds.When the ORI value reached 0.4, intravenous anesthesia induction was initiated using propofol 2 mg/kg, fentanyl 2 mcg/kg, and rocuronium 0.6mg/kg.During muscle relaxation, patients were not ventilated via mask.The ORI value at the time of induction and at the 2nd minute post-induction was recorded.If the ORI dropped below 0.24 before the 2-minute mark, mask ventilation was initiated, and the time of intervention was noted.Endotracheal intubation was then performed using a standard,atraumatic technique after achieving adequate muscle relaxation.

Other: OXYGEN RESERVE INDEX

ORI<0.24

Patients, aged between 18 and 60 years, classified as ASA physical status I-II,and with a Mallampati score \<2, were enrolled.On the day of surgery, following identity verification and confirmation of the surgical site, patients were positioned on a warmed operating table.Standard monitoring was applied, including ECG, SBP and DBP, SpO₂, and the ORI.Preoxygenation was achieved by administering 100% oxygen via 8 deep breaths over 60 seconds.When the ORI value reached 0.4, intravenous anesthesia induction was initiated using propofol 2 mg/kg, fentanyl 2 mcg/kg, and rocuronium 0.6mg/kg.During muscle relaxation, patients were not ventilated via mask.The ORI value at the time of induction and at the 2nd minute post-induction was recorded.If the ORI dropped below 0.24 before the 2-minute mark, mask ventilation was initiated, and the time of intervention was noted.Endotracheal intubation was then performed using a standard,atraumatic technique after achieving adequate muscle relaxation.

Other: OXYGEN RESERVE INDEX

Interventions

OXYGEN RESERVE INDEXOTHER

Noted for each patient.

ORI<0.24ORI>0.24

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

60 patients between the ages of 18-60 years, ASA 1-2, scheduled for elective laparoscopic cholecystectomy under general anesthesia.

You may qualify if:

  • years
  • ASA 1-2
  • Mallampati score \<2
  • Scheduled for elective laparoscopic cholecystectomy under general anesthesia

You may not qualify if:

  • \<18 and \>60 years
  • ASA 3-4
  • Initial ORI value below 0.24

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, çankaya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ApneaRespiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Central Study Contacts

Ayşegül Özel Erdem

CONTACT

05549777289aysegulozell@gmail.com

Ayça Özcan

CONTACT

05057154125draycaozcan@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

July 21, 2025

First Posted

August 13, 2025

Study Start

August 7, 2025

Primary Completion

August 21, 2025

Study Completion

August 30, 2025

Last Updated

August 13, 2025

Record last verified: 2025-08

Locations

TU(1)