Evaluating The Cardiovascular Effects of Tourniquet Application

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.

Study Overview

• Status: Completed
• Conditions: Orthopedic Disorder; Hemodynamic Instability
• Intervention / Treatment: Device: Mostcare (Vytech, Vygon, Padua, Italy)

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.

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Turkey
  • Üsküdar
    • Istanbul, Üsküdar, Turkey, 34662
      • Acibadem University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients Scheduled for Elective Unilateral Total Knee Arthroplasty Under Tourniquet Application

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
General Anesthesia; Patients undergoing elective unilateral total knee arthroplasty with tourniquet application under the general anesthesia technique	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).
Combined Spinal Epidural Anesthesia; Patients undergoing elective unilateral total knee arthroplasty with tourniquet application under the combined spinal epidural anesthesia technique	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Merve Şeker
• Collaborators: Acibadem University
• Investigators: Study Chair: Serap Aktaş yıldırım, doctor, Acibadem University; Study Chair: Bülent Güçyetmez, doctor, Acibadem University; Study Chair: Halim Ulugöl, doctor, Acibadem University; Study Chair: Fevzi Toraman, doctor, Acibadem University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: November 18, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: tourniquet; cardiac cycle efficiency; arterial elastance; dP/dtmax; cardiac power output
• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: AcibademStudy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Informed Consent Form will be shared
• IPD Sharing Time Frame: September 2022 and April 2023
• IPD Sharing Access Criteria: If requested, the Informed Consent Form will be shared via email
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No