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Evaluating The Cardiovascular Effects of Tourniquet Application

NCT ID: NCT06158165

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-04-01

Brief Summary

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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

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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.

Conditions

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Orthopedic Disorder Hemodynamic Instability

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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General Anesthesia

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

Mostcare (Vytech, Vygon, Padua, Italy)

Intervention Type 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

Patients undergoing elective unilateral total knee arthroplasty with tourniquet application under the combined spinal epidural anesthesia technique

Mostcare (Vytech, Vygon, Padua, Italy)

Intervention Type DEVICE

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

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Acibadem University

OTHER

Sponsor Role collaborator

Merve Şeker

OTHER

Sponsor Role lead

Responsible Party

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Merve Şeker

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Serap Aktaş yıldırım, doctor

Role: STUDY_CHAIR

Acibadem University

Bülent Güçyetmez, doctor

Role: STUDY_CHAIR

Acibadem University

Halim Ulugöl, doctor

Role: STUDY_CHAIR

Acibadem University

Fevzi Toraman, doctor

Role: STUDY_CHAIR

Acibadem University

Locations

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Acibadem University

Istanbul, Üsküdar, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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AcibademStudy

Identifier Type: -

Identifier Source: org_study_id