- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06847672
Comparison of the Time to Reach End-Tidal Oxygen Value of 90 and Oxygen Reserve Index Decline Times During Preoxygenation in Sarcopenic and Non-Sarcopenic Patients
February 21, 2025 updated by: Betül Güven, Ankara City Hospital Bilkent
Comparison of the Time to Reach End-Tidal Oxygen Value of 90 and Oxygen Reserve Index Decline Times During Preoxygenation in Sarcopenic and Non-Sarcopenic Patients Using the 6-Minute Walk Test
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Betül Güven Aytaç, Assoc.prof.
- Phone Number: +905073578351
- Email: drbguven@hotmail.com
Study Locations
-
-
-
Ankara, Turkey
- Ankara City Hospital Bilkent
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability 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.
Description
Inclusion Criteria:
- Patients who agree to participate in the study.
- Patients scheduled for major abdominal oncologic surgery.
Exclusion Criteria:
- Patients with severe cardiopulmonary disease.
- Patients with walking disabilities.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
sarcopenic
sarcopenia based on the 6-minute walk test results.
|
The time required to reach EtO2 90% and the time until ORI drops below 0.55
|
|
non-sarcopenic
non-sarcopenia based on the 6-minute walk test results.
|
The time required to reach EtO2 90% and the time until ORI drops below 0.55
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time required to reach EtO2 90%
Time Frame: preoperatively
|
preoperatively
|
|
Time until ORI drops below 0.55
Time Frame: preoperatively
|
preoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2025
Primary Completion (Estimated)
May 30, 2025
Study Completion (Estimated)
August 31, 2025
Study Registration Dates
First Submitted
February 18, 2025
First Submitted That Met QC Criteria
February 21, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 21, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TABED1-25-884
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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