Arrhythmia, CardiacNCT06936150
Effect of Tourniquet Use on ICEB and ICEBc in Upper Extremity Surgeries
An observational study of Arrhythmia, Cardiac and Tourniquet Complications, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
In our study, we will examine whether the pressure bandage (tourniquet) used to reduce bleeding during surgery in patients with arm fractures has an effect on heart rhythm. Tourniquet use is routinely used in every patient in these surgeries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Arrhythmia, Cardiac, Tourniquet Complications
- What is being tested?
- Electrocardiography
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2024to 27 Jan 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of patients who applied to the orthopedics and traumatology department of the training and research hospital due to isolated fractures in the upper extremity and were planned for elective surgery.
Who may be able to join
- American Society of Anesthesiology (ASA) risk group I-III, patients
- Upper extremity fracture which requires tourniquet application during surgery
Who cannot join
- bundle branch block in preoperative ECG
- patients with arrhythmia
- those taking antiarrhythmic drugs
- those with pacemakers
- patients with known drug-specific allergies
- patients with electrolyte disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırşehir Ahi Evran University Research and Education Hospital
Kırşehir/Merkez, Kırşehir, 40100
About this study
Official title: Effect of Tourniquet Use on Index of Cardiac-Electrophysiological Balance Calculations (ICEB and ICEBc) in Upper Extremity Surgeries
In our study, we will examine whether the pressure bandage (tourniquet) used to reduce bleeding during surgery in patients with arm fractures has an effect on heart rhythm. Tourniquet use is routinely used in every patient in these surgeries. This procedure reduces blood flow to the area where the surgery will be performed by applying a pressure bandage in order to reduce bleeding. At the end of the surgery, this bandage is removed and the blood flow returns to normal. Blood pressure changes that may occur during this process and the cellular effects of the changing blood flow may cause some changes in heart rhythm.
To observe those changes, during the operation, an electrocardiogram (ECG, heart graph) will be taken to determine changes in heart rhythm before and after the tourniquet is applied. An ECG is also performed before the surgery for preoperative anesthesia evaluation. The ECG procedure is a painless procedure that takes about 1 minute, includes placing probes on the chest and does not disrupt the integrity of the skin..The procedure will be performed while patients are under anesthesia.
Calculations will be made by the parameters on the ECG. Apart from taking an ECG, no other procedure will be performed on the patients
Read the detailed description
The use of a tourniquet during surgical repair of traumatic upper extremity fractures is a very common practice. Surgical Tourniquets are used in orthopaedic for creation of a bloodless field, greater safety, better precision, and more convenience for the surgeon. Despite the ease it provides in terms of surgery, the use of a tourniquet can lead to some complications.
Most surgical tourniquets are of the pneumatic design.(1) When using a pneumatic tourniquet in upper extremity surgeries, a pressure of 150-250 mmHg is usually applied. The blood flow to the extremity is cut off by this pressure effect. However, stopping the circulation causes temporary ischemia. Limb occlusion causes metabolic changes in the ischemic limb that include: Increased lactic acid, PaCO2 and potassium levels, and decreased levels of PaO2, and pH. Toxic metabolites produce pathophysiological changes when released into the general circulation.(2, 3). The degree of these changes correlates with the duration of ischemia. All of these changes are fully reversed within 30 min of tourniquet deflation. (4) These metabolic changes may have negative effects on cardiac electrical activity. Theoretically, there is a risk that these ischemic metabolites and pH changes may trigger cardiac arrhythmias.
Indeed, pre-clinical studies demonstrated that λ,( λ=effective refractory period × conduction velocity) was the best predictor of arrhythmic tendency, increasing with pro-arrhythmic conditions and decreasing by anti-arrhythmic therapy.(5) The fact that λ must be assessed invasively using electrophysiological investigations in a clinical context is a significant drawback, though. The index of Cardiac-Electrophysiological Balance" (iCEB), which is the ratio of QT/QRS of the ECG, was proposed as the noninvasively measured equivalent of λ by Lu et al.(6) In addition, ICEBc, a version calculated with Qtc instead of Qt, has been used in various studies to predict arrhythmia risk, similar to ICEB (7, 8).
In our study, we aimed to investigate whether ischemic metabolites and other systemic effects occurring after tourniquet application in upper extremity surgeries create any changes on the ICEB and ICEBc values of patients.
The study was designed as a prospective, observational study. Patients were included in the study after their consent to participate was obtained by the anesthesiologists during the preoperative evaluation in the anesthesia outpatient clinic of a training and research hospital. All data related to the study were recorded by the same anesthesia team.
During the preoperative evaluation, American Society of Anesthesiology (ASA) risk group I-III, patients between the ages of 18-65, who were scheduled for elective upper extremity fixation surgery were included in the study.
Patients with bundle branch block in preoperative ECG, patients with arrhythmia, those taking antiarrhythmic drugs, those with pacemakers, patients with known drug-specific allergies, and patients with electrolyte disorders were not included in the study.
The primary outcome of our study was whether there was a significant increase in ICEB and ICEBc values after tourniquet deflation compared to before opening. The secondary outcome of the study was whether there was a significant increase in ICEB and ICEBc values measured at the beginning and end of surgery.
For upper extremity fixation surgery, before anesthesia induction (ICEB1/ICEBc1), after induction (ICEB2/ICEBc2), 5 minutes before the tourniquet was inflated (ICEB3/ICEBc3), 5 minutes after it was inflated (ICEB4/ICEBc4), 5 minutes before the tourniquet was opened (ICEB5/ICEBc5) and 5 minutes after it was opened (ICEB6/ICEBc6), ECG was taken . ECG measurements were performed and ICEB and ICEBc values were calculated using the D II and V5 derivations in these ECGs. After calculating QT, QTc and QRS durations, iCEB and ICEBc calculations will be made. iCEB is calculated by dividing the QT interval by the QRS duration (QT/ QRS). iCEBc is calculated by dividing the QTc interval by the QRS duration (QTc/ QRS).
Simultaneously, mean arterial pressure, heart rate, oxygen saturation were recorded non-invasively.
- Conditions
- Arrhythmia, Cardiac, Tourniquet Complications
- Being tested
- Electrocardiography
- Keywords
- ICEB, ICEBc, Surgical Tourniquet, Cardiac Arrhytmia
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocardiographyOther
Electrocardiography (ECG) is a non-invasive test used to measure the electrical activity of the heart. It involves placing electrodes on all four extremities and the chest area of the person and measuring the derivation between these electrodes. This procedure is painless and does not contain any elements that will disrupt the integrity of the body.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of ICEB and ICEBc with the opening of the tourniquet
Primary outcome is whether there was a significant increase in ICEB and ICEBc values after tourniquet deflation compared to before opening
Measured: Difference between 5 minutes before the end of the surgical tourniquet application and 5 minutes after the tourniquet was opened
Secondary outcomes (1)
Changes in ICEB and ICEBc during surgery
The secondary outcome of the study was whether there was a significant increase in ICEB and ICEBc values measured at the beginning and end of surgery.
Measured: The time interval between the minute immediately before the start of anesthesia and 5 minutes after the tourniquet is opened.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start10 Jul 2024
- Primary completion7 Jan 2025
- Study completion27 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmia, CardiacStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Nur Arslan, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936150
- Sponsor's protocol ID
- 2024-13/108
- Status last verified
- Apr 2025
- First submitted
- 12 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: We have not yet decided whether to share the IPDs of our study.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tourniquet Use on Index of Cardiac-Electrophysiological Balance Calculations (ICEB and ICEBc) in Upper Extremity Surgeries
- ClinicalTrials.gov ID
- NCT06936150
- Acronym / sponsor ID
- 2024-13/108
- Conditions
- Arrhythmia, Cardiac, Tourniquet Complications
- Keywords
- ICEB, ICEBc, Surgical Tourniquet, Cardiac Arrhytmia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 20 Apr 2025 (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.
In our study, we will examine whether the pressure bandage (tourniquet) used to reduce bleeding during surgery in patients with arm fractures has an effect on heart rhythm. Tourniquet use is routinely used in every patient in these surgeries. This procedure reduces blood flow to the area where the surgery will be performed by applying a pressure bandage in order to reduce bleeding. At the end of the surgery, this bandage is removed and the blood flow returns to normal. Blood pressure changes that may occur during this process and the cellular effects of the changing blood flow may cause some changes in heart rhythm.
To observe those changes, during the operation, an electrocardiogram (ECG, heart graph) will be taken to determine changes in heart rhythm before and after the tourniquet is applied. An ECG is also performed before the surgery for preoperative anesthesia evaluation. The ECG procedure is a painless procedure that takes about 1 minute, includes placing probes on the chest and does not disrupt the integrity of the skin..The procedure will be performed while patients are under anesthesia.
Calculations will be made by the parameters on the ECG. Apart from taking an ECG, no other procedure will be performed on the patients
Detailed description
The use of a tourniquet during surgical repair of traumatic upper extremity fractures is a very common practice. Surgical Tourniquets are used in orthopaedic for creation of a bloodless field, greater safety, better precision, and more convenience for the surgeon. Despite the ease it provides in terms of surgery, the use of a tourniquet can lead to some complications.
Most surgical tourniquets are of the pneumatic design.(1) When using a pneumatic tourniquet in upper extremity surgeries, a pressure of 150-250 mmHg is usually applied. The blood flow to the extremity is cut off by this pressure effect. However, stopping the circulation causes temporary ischemia. Limb occlusion causes metabolic changes in the ischemic limb that include: Increased lactic acid, PaCO2 and potassium levels, and decreased levels of PaO2, and pH. Toxic metabolites produce pathophysiological changes when released into the general circulation.(2, 3). The degree of these changes correlates with the duration of ischemia. All of these changes are fully reversed within 30 min of tourniquet deflation. (4) These metabolic changes may have negative effects on cardiac electrical activity. Theoretically, there is a risk that these ischemic metabolites and pH changes may trigger cardiac arrhythmias.
Indeed, pre-clinical studies demonstrated that λ,( λ=effective refractory period × conduction velocity) was the best predictor of arrhythmic tendency, increasing with pro-arrhythmic conditions and decreasing by anti-arrhythmic therapy.(5) The fact that λ must be assessed invasively using electrophysiological investigations in a clinical context is a significant drawback, though. The index of Cardiac-Electrophysiological Balance" (iCEB), which is the ratio of QT/QRS of the ECG, was proposed as the noninvasively measured equivalent of λ by Lu et al.(6) In addition, ICEBc, a version calculated with Qtc instead of Qt, has been used in various studies to predict arrhythmia risk, similar to ICEB (7, 8).
In our study, we aimed to investigate whether ischemic metabolites and other systemic effects occurring after tourniquet application in upper extremity surgeries create any changes on the ICEB and ICEBc values of patients.
The study was designed as a prospective, observational study. Patients were included in the study after their consent to participate was obtained by the anesthesiologists during the preoperative evaluation in the anesthesia outpatient clinic of a training and research hospital. All data related to the study were recorded by the same anesthesia team.
During the preoperative evaluation, American Society of Anesthesiology (ASA) risk group I-III, patients between the ages of 18-65, who were scheduled for elective upper extremity fixation surgery were included in the study.
Patients with bundle branch block in preoperative ECG, patients with arrhythmia, those taking antiarrhythmic drugs, those with pacemakers, patients with known drug-specific allergies, and patients with electrolyte disorders were not included in the study.
The primary outcome of our study was whether there was a significant increase in ICEB and ICEBc values after tourniquet deflation compared to before opening. The secondary outcome of the study was whether there was a significant increase in ICEB and ICEBc values measured at the beginning and end of surgery.
For upper extremity fixation surgery, before anesthesia induction (ICEB1/ICEBc1), after induction (ICEB2/ICEBc2), 5 minutes before the tourniquet was inflated (ICEB3/ICEBc3), 5 minutes after it was inflated (ICEB4/ICEBc4), 5 minutes before the tourniquet was opened (ICEB5/ICEBc5) and 5 minutes after it was opened (ICEB6/ICEBc6), ECG was taken . ECG measurements were performed and ICEB and ICEBc values were calculated using the D II and V5 derivations in these ECGs. After calculating QT, QTc and QRS durations, iCEB and ICEBc calculations will be made. iCEB is calculated by dividing the QT interval by the QRS duration (QT/ QRS). iCEBc is calculated by dividing the QTc interval by the QRS duration (QTc/ QRS).
Simultaneously, mean arterial pressure, heart rate, oxygen saturation were recorded non-invasively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of patients who applied to the orthopedics and traumatology department of the training and research hospital due to isolated fractures in the upper extremity and were planned for elective surgery.
Key inclusion criteria (2 listed)
- American Society of Anesthesiology (ASA) risk group I-III, patients
- Upper extremity fracture which requires tourniquet application during surgery
Key exclusion criteria (6 listed)
- bundle branch block in preoperative ECG
- patients with arrhythmia
- those taking antiarrhythmic drugs
- those with pacemakers
- patients with known drug-specific allergies
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 |
|---|---|---|
| ElectrocardiographyElectrocardiography (ECG) is a non-invasive test used to measure the electrical activity of the heart. It involves placing electrodes on all four extremities and the chest area of the person and measuring the derivation between these electrodes. This procedure is painless and does not contain any elements that will disrupt the integrity of the body. | Other | – |
Primary outcome
Change of ICEB and ICEBc with the opening of the tourniquet
Time frame: Difference between 5 minutes before the end of the surgical tourniquet application and 5 minutes after the tourniquet was opened
Primary outcome is whether there was a significant increase in ICEB and ICEBc values after tourniquet deflation compared to before opening
1 secondary outcome
Changes in ICEB and ICEBc during surgery
Time frame: The time interval between the minute immediately before the start of anesthesia and 5 minutes after the tourniquet is opened.
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 20 Apr 2025.
- Individual participant dataSharing planned: Undecided. We have not yet decided whether to share the IPDs of our study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Arrhythmia, Cardiac and Tourniquet Complications, run by Kirsehir Ahi Evran Universitesi 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 2 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 20 Apr 2025. 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?
Change of ICEB and ICEBc with the opening of the tourniquet (time frame: Difference between 5 minutes before the end of the surgical tourniquet application and 5 minutes after the tourniquet was opened). 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 20 Apr 2025.