SarcopeniaNCT07688941
Preoperative Performance Indicators, Preoxygenation and Oxygen Reserve Relationship
An observational study of Sarcopenia and Handgrip Strength Test, run by Ankara City Hospital Bilkent.
Trial summary
The goal of this observational study is to evaluate the relationship between preoperative cardiopulmonary performance indicators and preoxygenation efficiency along with oxygen reserve depletion in patients scheduled for elective surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Handgrip Strength Test, Preoxygenation
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2026to 3 Dec 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for elective surgery at Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation, who will undergo preoxygenation before anesthesia induction.
Who may be able to join
- Patients aged >18 years ASA physical status I-III Scheduled for elective surgery under general anesthesia Voluntary written informed consent to participate in the study
Who cannot join
- Severe COPD (Chronic Obstructive Pulmonary Disease) or restrictive lung disease NYHA Class III-IV Heart Failure Neuromuscular diseases Upper extremity pathologies affecting hand function (preventing HGS measurement) Orthopedic or neurological conditions preventing the 6-minute walk test (6MWT) Emergency surgeries
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Relationship Between Preoperative Cardiopulmonary Performance Indicators (Hand Grip Strength and 6-Minute Walk Test) and Preoxygenation and Oxygen Reserve
The goal of this observational study is to evaluate the relationship between preoperative cardiopulmonary performance indicators and preoxygenation efficiency along with oxygen reserve depletion in patients scheduled for elective surgery under general anesthesia. The main questions it aims to answer are:
What is the relationship between Hand Grip Strength (HGS) and the time taken for end-tidal oxygen (EtO_2) to reach 90% during preoxygenation? What is the relationship between the 6-Minute Walk Test (6MWT) distance and the Oxygen Reserve Index (ORI) depletion time during the apnea period?
Read more
Participants will be asked to perform the following tasks during their preoperative and intraoperative care:
Complete a 6-Minute Walk Test (6MWT) to determine preoperative functional capacity.
Perform a Hand Grip Strength (HGS) test using a calibrated hand dynamometer to measure muscle strength.
Undergo standardized preoxygenation with 100% oxygen via a tight-fitting face mask in the operating room while end-tidal oxygen (EtO_2) and Oxygen Reserve Index (ORI) levels are continuously monitored.
- Conditions
- Sarcopenia, Handgrip Strength Test, Preoxygenation
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Patients Evaluated for Cardiopulmonary Performance | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoxygenation Efficiency (EtO_2 Time)
The time taken for end-tidal oxygen (EtO_2) to reach 90% during preoxygenation.
Measured: From the initiation of preoxygenation (0 seconds) until the EtO_2 values reach 90% (typically within 3 to 5 minutes before anesthesia induction)
Oxygen Reserve Depletion Time (ORI Time)
The time duration for the Oxygen Reserve Index (ORI) value to drop below 0.55.
Measured: From the cessation of preoxygenation/initiation of apnea until the ORI drops below 0.55
Secondary outcomes (2)
Preoperative Functional Capacity (6MWT)
Total functional distance walked during the 6-minute walk test
Measured: Preoperative period
Preoperative Muscle Strength (HGS)
Muscle strength measured using a calibrated hand dynamometer (the highest value of three consecutive measurements using the dominant hand)
Measured: Preoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start5 Jul 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion3 Dec 2026 (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.
- 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
- 120 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
- NCT07688941
- Sponsor's protocol ID
- TABED1-26-2498
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- 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 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Preoperative Cardiopulmonary Performance Indicators (Hand Grip Strength and 6-Minute Walk Test) and Preoxygenation and Oxygen Reserve
- ClinicalTrials.gov ID
- NCT07688941
- Acronym / sponsor ID
- TABED1-26-2498
- Conditions
- Sarcopenia, Handgrip Strength Test, Preoxygenation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 5 Jul 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 3 Dec 2026 (estimated)
- First posted
- 7 Jul 2026 (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 goal of this observational study is to evaluate the relationship between preoperative cardiopulmonary performance indicators and preoxygenation efficiency along with oxygen reserve depletion in patients scheduled for elective surgery under general anesthesia. The main questions it aims to answer are:
What is the relationship between Hand Grip Strength (HGS) and the time taken for end-tidal oxygen (EtO_2) to reach 90% during preoxygenation? What is the relationship between the 6-Minute Walk Test (6MWT) distance and the Oxygen Reserve Index (ORI) depletion time during the apnea period?
Participants will be asked to perform the following tasks during their preoperative and intraoperative care:
Complete a 6-Minute Walk Test (6MWT) to determine preoperative functional capacity.
Perform a Hand Grip Strength (HGS) test using a calibrated hand dynamometer to measure muscle strength.
Undergo standardized preoxygenation with 100% oxygen via a tight-fitting face mask in the operating room while end-tidal oxygen (EtO_2) and Oxygen Reserve Index (ORI) levels are continuously monitored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Patients Evaluated for Cardiopulmonary Performance | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective surgery at Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation, who will undergo preoxygenation before anesthesia induction.
Key inclusion criteria (1 listed)
- Patients aged >18 years ASA physical status I-III Scheduled for elective surgery under general anesthesia Voluntary written informed consent to participate in the study
Key exclusion criteria (1 listed)
- Severe COPD (Chronic Obstructive Pulmonary Disease) or restrictive lung disease NYHA Class III-IV Heart Failure Neuromuscular diseases Upper extremity pathologies affecting hand function (preventing HGS measurement) Orthopedic or neurological conditions preventing the 6-minute walk test (6MWT) Emergency surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preoxygenation Efficiency (EtO_2 Time)
Time frame: From the initiation of preoxygenation (0 seconds) until the EtO_2 values reach 90% (typically within 3 to 5 minutes before anesthesia induction)
The time taken for end-tidal oxygen (EtO_2) to reach 90% during preoxygenation.
Oxygen Reserve Depletion Time (ORI Time)
Time frame: From the cessation of preoxygenation/initiation of apnea until the ORI drops below 0.55
The time duration for the Oxygen Reserve Index (ORI) value to drop below 0.55.
2 secondary outcomes
Preoperative Functional Capacity (6MWT)
Time frame: Preoperative period
Preoperative Muscle Strength (HGS)
Time frame: Preoperative period
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 7 Jul 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Handgrip Strength Test, run by Ankara City Hospital Bilkent.
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 1 inclusion and 1 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 (+905073578351, drbguven@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoxygenation Efficiency (EtO_2 Time) (time frame: From the initiation of preoxygenation (0 seconds) until the EtO_2 values reach 90% (typically within 3 to 5 minutes before anesthesia induction)). 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 7 Jul 2026.