Effect of Tourniquet Use on Index of Cardiac-Electrophysiological Balance Calculations (ICEB and ICEBc) in Upper Extremity Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change of ICEB and ICEBc with the opening of the tourniquet
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiology (ASA) risk group I-III, patients
- •Upper extremity fracture which requires tourniquet application during surgery
排除标准
- •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
结局指标
主要结局
Change of ICEB and ICEBc with the opening of the tourniquet
时间窗: 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
次要结局
- 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.)
研究者
Fatma Nur Arslan
MD, Anesthesiology and Reanimation
Kirsehir Ahi Evran Universitesi
