Evaluating The Cardiovascular Effects of Tourniquet Application

NCT06158165 | Completed

• 1 other identifier: AcibademStudy
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic Disorder; Hemodynamic Instability

Keywords

cardiac cycle efficiency; arterial elastance; dP/dtmax; cardiac power output; tourniquet

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

General Anesthesia

Patients undergoing elective unilateral total knee arthroplasty with tourniquet application under the general anesthesia technique

Device: Mostcare (Vytech, Vygon, Padua, Italy)

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)

Interventions

Mostcare (Vytech, Vygon, Padua, Italy) DEVICE

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; General Anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients Scheduled for Elective Unilateral Total Knee Arthroplasty Under Tourniquet Application

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merve Şeker: lead
• Acibadem University: collaborator

Study Sites (1)

Acibadem University

Istanbul, Üsküdar, 34662, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• 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 CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: December 6, 2023
• Study Start: September 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: September 2022 and April 2023
• Access Criteria: If requested, the Informed Consent Form will be shared via email

Locations

TU (1)