Orthopedic DisorderNCT06158165
Evaluating The Cardiovascular Effects of Tourniquet Application
An observational study of Orthopedic Disorder and Hemodynamic Instability, run by Merve Şeker at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthopedic Disorder, Hemodynamic Instability
- What is being tested?
- Mostcare (Vytech, Vygon, Padua, Italy)
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 1 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients Scheduled for Elective Unilateral Total Knee Arthroplasty Under Tourniquet Application
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Orthopedic Disorder, Hemodynamic Instability
- Being tested
- Mostcare (Vytech, Vygon, Padua, Italy)
- Keywords
- cardiac cycle efficiency, arterial elastance, dP/dtmax, cardiac power output, tourniquet
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | Patients undergoing elective unilateral total knee arthroplasty with tourniquet application under the general anesthesia technique Receives: 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 Receives: Device: Mostcare (Vytech, Vygon, Padua, Italy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Sep 2022
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merve Şeker
- Sponsor type
- University, hospital or other
- Collaborators
- Acibadem University
- Responsible party
- Sponsor-investigator, Merve Şeker, Acibadem University
- Investigators
- Serap Aktaş yıldırım, doctor, Study chair, Acibadem UniversityBülent Güçyetmez, doctor, Study chair, Acibadem UniversityHalim Ulugöl, doctor, Study chair, Acibadem UniversityFevzi Toraman, doctor, Study chair, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158165
- Sponsor's protocol ID
- AcibademStudy
- Status last verified
- Dec 2023
- First submitted
- 18 Nov 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Informed Consent Form will be shared
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating The Cardiovascular Effects of Tourniquet Application
- ClinicalTrials.gov ID
- NCT06158165
- Acronym / sponsor ID
- AcibademStudy
- Conditions
- Orthopedic Disorder, Hemodynamic Instability
- Keywords
- cardiac cycle efficiency, arterial elastance, dP/dtmax, cardiac power output, tourniquet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Merve ŞekerUniversity, hospital or other
- Collaborators
- Acibadem University
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | – | Device: Mostcare (Vytech, Vygon, Padua, Italy)Patients undergoing elective unilateral total knee arthroplasty with tourniquet application under the general anesthesia technique |
| Combined Spinal Epidural Anesthesia | – | Device: Mostcare (Vytech, Vygon, Padua, Italy)Patients undergoing elective unilateral total knee arthroplasty with tourniquet application under the combined spinal epidural anesthesia technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients Scheduled for Elective Unilateral Total Knee Arthroplasty Under Tourniquet Application
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Combined Spinal Epidural Anesthesia, General Anesthesia |
Primary outcome
Cardiac Cycle Efficiency (CCE), which measured with the MostCare (Vytech, Vygon, Padua, Italy) device employing the Pressure Recording Analytic Method (PRAM).
Time frame: 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
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: Yes. The Informed Consent Form will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serap Aktaş yıldırım, doctor study chair
Acibadem University
Bülent Güçyetmez, doctor study chair
Acibadem University
Halim Ulugöl, doctor study chair
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Disorder and Hemodynamic Instability, run by Merve Şeker at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Cycle Efficiency (CCE), which measured with the MostCare (Vytech, Vygon, Padua, Italy) device employing the Pressure Recording Analytic Method (PRAM). (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.