NCT Number: NCT07688941
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 opening soon.
Get Notified18 year and older
All sexes
Observational
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
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.
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.
Time frame: Preoperative period
Total functional distance walked during the 6-minute walk test
Time frame: Preoperative period
Muscle strength measured using a calibrated hand dynamometer (the highest value of three consecutive measurements using the dominant hand)
Contact information is provided by the study sponsor or research team.
Ankara City Hospital Bilkent
Other
Evaluation of the Relationship Between Preoperative Cardiopulmonary Performance Indicators (Hand Grip Strength and 6-Minute Walk Test) and Preoxygenation and Oxygen Reserve
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06847672
Atrophy, Muscular Atrophy
Ankara, Turkey (Türkiye)
View Trial DetailsNCT02797197
Atrophy, Chemotherapy
View Trial DetailsNCT07732478
Atrophy, Frailty
Granada, Andalusia, Spain
View Trial DetailsNCT07531498
Atrophy, Low Muscle Mass
Memphis, Tennessee, United States
View Trial Details