- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07688941
Preoperative Performance Indicators, Preoxygenation and Oxygen Reserve Relationship
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Betül Güven Aytaç
- Telefonnummer: +905073578351
- E-mail: drbguven@hotmail.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Surgical Patients Evaluated for Cardiopulmonary Performance
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Preoxygenation Efficiency (EtO_2 Time)
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Preoperative Functional Capacity (6MWT)
Tidsramme: Preoperative period
|
Total functional distance walked during the 6-minute walk test
|
Preoperative period
|
|
Preoperative Muscle Strength (HGS)
Tidsramme: Preoperative period
|
Muscle strength measured using a calibrated hand dynamometer (the highest value of three consecutive measurements using the dominant hand)
|
Preoperative period
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TABED1-26-2498
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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