Preoperative Performance Indicators, Preoxygenation and Oxygen Reserve Relationship

June 30, 2026 updated by: Betül Güven, Ankara City Hospital Bilkent

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?

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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

120

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

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

Yes

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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
Surgical Patients Evaluated for Cardiopulmonary Performance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
From the cessation of preoxygenation/initiation of apnea until the ORI drops below 0.55

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative Functional Capacity (6MWT)
Time Frame: Preoperative period
Total functional distance walked during the 6-minute walk test
Preoperative period
Preoperative Muscle Strength (HGS)
Time Frame: Preoperative period
Muscle strength measured using a calibrated hand dynamometer (the highest value of three consecutive measurements using the dominant hand)
Preoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

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)

July 5, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 3, 2026

Study Registration Dates

First Submitted

June 30, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TABED1-26-2498

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

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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