Clinical trial NCT06158165: Evaluating The Cardiovascular Effects of Tourniquet Application
Official title: Evaluating The Cardiovascular Effects of Tourniquet Application
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthopedic Disorder
Hemodynamic Instability
Keywords: cardiac cycle efficiency
arterial elastance
dP/dtmax
cardiac power output
tourniquet
Lead sponsor: Acibadem University
Sponsor class: OTHER
Collaborators: name: Acibadem University
First posted: 2023-12-06
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients Scheduled for Elective Unilateral Total Knee Arthroplasty Under Tourniquet Application

Brief summary: The goal of this prospective observational study is to investigate the impact of tourniquet application on cardiac efficiency through the cardiac cycle efficiency parameter and to explore how central regional technique alters this effect compared to general anesthesia.

We aim to answer the following main questions: 1) Does the use of a tourniquet reduce cardiac efficiency? 2) Does the impact of tourniquet use on cardiac efficiency vary with general anesthesia or central regional technique? The patients included in the study will be divided into two groups based on whether they receive general anesthesia or combined spinal epidural anesthesia.The patients' cardiac cycle efficiency and advanced hemodynamic monitoring parameters will be recorded during procedure.

Detailed description: After obtaining ethical committee approval (ATADEK; 2022-14/12), 43 patients undergoing elective unilateral total knee arthroplasty under tourniquet were enrolled in our prospective observational study. Patients were divided into two groups: general anesthesia (Group GA: 22 patients) or combined spinal epidural anesthesia (Group CSEA: 21 patients). Cardiac and vascular parameters were recorded using the new algorithmic application of arterial wave analysis called Pressure Recording Analytical Method (PRAM) at 9 time points: (T1) pre-anesthesia, (T2) post-anesthesia before tourniquet inflation, (T3-8) during tourniquet inflation, and (T9) after tourniquet deflation.

Eligibility criteria: Inclusion Criteria:

* Planned for Elective Unilateral Total Knee Arthroplasty Under Tourniquet Application
* Aged 18 and over
* Either general anesthesia (GA) or combined spinal-epidural anesthesia (CSEA) will be administered

Exclusion Criteria:

* Patients under 18 years of age
* Patients with heart failure
* Patients with valve disease
* Patients with rhythm disorders
* Patients with a history of myocardial infarction in the last 3 months
* Patients unwilling to provide consent

Primary outcomes:
measure: Cardiac Cycle Efficiency (CCE), which measured with the MostCare (Vytech, Vygon, Padua, Italy) device employing the Pressure Recording Analytic Method (PRAM).
timeFrame: 1 minute before and 10 minutes after anesthesia induction, 10-2-30-60 minutes after tourniquet inflation, 1 minute before tourniquet deflation, 1 minute and 5 minutes after tourniquet deflation
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem University
state: Üsküdar
Study officials:
affiliation: Acibadem University
name: Serap Aktaş yıldırım, doctor
role: STUDY_CHAIR
affiliation: Acibadem University
name: Bülent Güçyetmez, doctor
role: STUDY_CHAIR
affiliation: Acibadem University
name: Halim Ulugöl, doctor
role: STUDY_CHAIR
affiliation: Acibadem University
name: Fevzi Toraman, doctor
role: STUDY_CHAIR
References: