Effect of Tourniquet Use on ICEB and ICEBc in Upper Extremity Surgeries

NCT06936150 | Completed

• 1 other identifier: 2024-13/108
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Arrhythmia, Cardiac; Tourniquet Complications

Keywords

ICEB; ICEBc; Surgical Tourniquet; Cardiac Arrhytmia

Outcome Measures

Primary Outcomes (1)

• 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

  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 time interval between the minute immediately before the start of anesthesia and 5 minutes after the tourniquet is opened.

Interventions

Electrocardiography OTHER

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• American Society of Anesthesiology (ASA) risk group I-III, patients
• Upper extremity fracture which requires tourniquet application during surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Kırşehir Ahi Evran University Research and Education Hospital

Kırşehir/Merkez, Kırşehir, 40100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthesiology and Reanimation

Study Record Dates

• First Submitted: April 12, 2025
• First Posted: April 20, 2025
• Study Start: July 10, 2024
• Primary Completion: January 7, 2025
• Study Completion: January 27, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-04

Locations

TU (1)