SarcopeniaNCT06847672
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
An observational study of Sarcopenia and Preoxygenation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Preoxygenation, Oxygen Reserve Index
- What is being tested?
- preoxygenation
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 31 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients who agree to participate in the study.
- Patients scheduled for major abdominal oncologic surgery.
Who cannot join
- Patients with severe cardiopulmonary disease.
- Patients with walking disabilities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Sarcopenia, Preoxygenation, Oxygen Reserve Index
- Being tested
- preoxygenation
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoxygenationDiagnostic test
The time required to reach EtO2 90% and the time until ORI drops below 0.55
| Study group | Role | What they receive |
|---|---|---|
| sarcopenic | sarcopenia based on the 6-minute walk test results. Receives: Diagnostic Test: preoxygenation | |
| non-sarcopenic | non-sarcopenia based on the 6-minute walk test results. Receives: Diagnostic Test: preoxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required to reach EtO2 90%
Measured: preoperatively
Time until ORI drops below 0.55
Measured: preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Güven, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847672
- Sponsor's protocol ID
- TABED1-25-884
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06847672
- Acronym / sponsor ID
- TABED1-25-884
- Conditions
- Sarcopenia, Preoxygenation, Oxygen Reserve Index
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sarcopenic | – | Diagnostic Test: preoxygenationsarcopenia based on the 6-minute walk test results. |
| non-sarcopenic | – | Diagnostic Test: preoxygenationnon-sarcopenia based on the 6-minute walk test results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients who agree to participate in the study.
- Patients scheduled for major abdominal oncologic surgery.
Key exclusion criteria (2 listed)
- Patients with severe cardiopulmonary disease.
- Patients with walking disabilities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preoxygenationThe time required to reach EtO2 90% and the time until ORI drops below 0.55 | Diagnostic test | non-sarcopenic, sarcopenic |
Primary outcome
Time required to reach EtO2 90%
Time frame: preoperatively
Time until ORI drops below 0.55
Time frame: preoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Preoxygenation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Betül Güven Aytaç, Assoc.prof. (+905073578351, drbguven@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time required to reach EtO2 90% (time frame: preoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.