NCT07688941

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Jul 2026

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Jul 2026Dec 2026

First Submitted

Initial submission to the registry

June 30, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

July 5, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2026

Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 30, 2026

Last Update Submit

June 30, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Preoxygenation Efficiency (EtO_2 Time)

    The time taken for end-tidal oxygen (EtO\_2) to reach 90% during preoxygenation.

    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.

    From the cessation of preoxygenation/initiation of apnea until the ORI drops below 0.55

Secondary Outcomes (2)

  • Preoperative Functional Capacity (6MWT)

    Preoperative period

  • Preoperative Muscle Strength (HGS)

    Preoperative period

Study Arms (1)

Surgical Patients Evaluated for Cardiopulmonary Performance

Eligibility Criteria

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

Patients scheduled for elective surgery at Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation, who will undergo preoxygenation before anesthesia induction.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assos prof

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 7, 2026

Study Start

July 5, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 3, 2026

Last Updated

July 7, 2026

Record last verified: 2026-06