Evaluating The Cardiovascular Effects of Tourniquet Application

Hemodynamic Instability Clinical Trial

Official title:

Evaluating The Cardiovascular Effects of Tourniquet Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06158165
• Other study ID #: AcibademStudy
• Status: Completed
• Start date: September 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: December 2023
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Instability
• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

Device:
• Mostcare (Vytech, Vygon, Padua, Italy)
Parameters were observed through the utilization of the MostCare (Vytech, Vygon, Padua, Italy) device employing the Pressure Recording Analytic Method (PRAM).

Locations

Country	Name	City	State
Turkey	Acibadem University	Istanbul	Üsküdar

Sponsors (2)

Lead Sponsor	Collaborator
Merve Seker	Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Cycle Efficiency (CCE), which measured with the MostCare (Vytech, Vygon, Padua, Italy) device employing the Pressure Recording Analytic Method (PRAM).	The CCE value must be less than 1. Approaching zero or falling to a negative value indicates a decrease in cardiac efficiency and activation of the myocardial compensation mechanisms. The PRAM minimises artefacts and data variability in patients with haemodynamic instability with its high resolution by acquiring 1000 data per second.; The CCE parameter, which we utilized to assess the impact of tourniquet application on cardiac efficiency, was measured at the following time points: 1 minute before anesthesia induction (T1), 10 minutes after anesthesia induction, which is 1 minute before tourniquet inflation (T2), 10 minutes after tourniquet inflation (T3), 20 minutes after tourniquet inflation (T4), 30 minutes after tourniquet inflation (T5), 60 minutes after tourniquet inflation (T6), 1 minute before tourniquet deflation (T7), 1 minute after tourniquet deflation (T8), and 5 minutes after tourniquet deflation (T9).	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