Preoperative Performance Indicators, Preoxygenation and Oxygen Reserve Relationship
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sarcopenia, Handgrip Strength Test, Preoxygenation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Relationship Between Preoperative Cardiopulmonary Performance Indicators (Hand Grip Strength and 6-Minute Walk Test) and Preoxygenation and Oxygen Reserve
Overview
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.
Primary outcome measures
- 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)]
- Oxygen Reserve Depletion Time (ORI Time) [Time frame: From the cessation of preoxygenation/initiation of apnea until the ORI drops below 0.55]
Secondary outcome measures (2)
- Preoperative Functional Capacity (6MWT) [Time frame: Preoperative period]
- Preoperative Muscle Strength (HGS) [Time frame: Preoperative period]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07688941 · TABED1-26-2498