NCT06847672

Brief Summary

The purpose of this study is to compare the time required to reach an end-tidal oxygen (EtO2) value of 90% and the time until the Oxygen Reserve Index (ORI) drops below 0.55 during preoxygenation in sarcopenic and non-sarcopenic patients. The study aims to investigate the impact of sarcopenia on the oxygenation process.

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
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 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

February 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 26, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

February 18, 2025

Last Update Submit

February 21, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Time required to reach EtO2 90%

    preoperatively

  • Time until ORI drops below 0.55

    preoperatively

Study Arms (2)

sarcopenic

sarcopenia based on the 6-minute walk test results.

Diagnostic Test: preoxygenation

non-sarcopenic

non-sarcopenia based on the 6-minute walk test results.

Diagnostic Test: preoxygenation

Interventions

preoxygenationDIAGNOSTIC_TEST

The time required to reach EtO2 90% and the time until ORI drops below 0.55

non-sarcopenicsarcopenic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

80 patients who agreed to participate in the study and are scheduled for major abdominal oncological surgery will be included in the study.

You may qualify if:

  • Patients who agree to participate in the study.
  • Patients scheduled for major abdominal oncologic surgery.

You may not qualify if:

  • Patients with severe cardiopulmonary disease.
  • Patients with walking disabilities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital Bilkent

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Central Study Contacts

Betül Güven Aytaç, Assoc.prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ankara Bilkent City Hospital

Study Record Dates

First Submitted

February 18, 2025

First Posted

February 26, 2025

Study Start

March 1, 2025

Primary Completion

May 30, 2025

Study Completion

August 31, 2025

Last Updated

February 26, 2025

Record last verified: 2025-02

Locations