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临床试验/NCT02317029
NCT02317029终止不适用

A Comparison of Two Biphasic Waveforms and Impact of Oxygen on Myocardial Injury Following Cardioversion

Randers Regional Hospital2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2013年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
134
试验地点
2
主要终点
Defibrillator Efficiency: Proportion of patients in sinus rhythm four hours post cardioversion

研究概览

简要总结

Background:

Cardiac arrhythmias can be terminated by electrical current applied by an external defibrillator. This treatment, named cardioversion, has been used for decades in the treatment of atrial fibrillation.

Several kinds of defibrillators exist, though the relative efficacy and safety of these defibrillators is not clear.

During cardioversion, oxygen is being administered, and it has been a long-held belief that oxygen is always beneficial for the patient. This is now being challenged by recent studies suggesting excessive oxygenation to be potentially dangerous for the patients.

Objective:

  1. To compare the efficiency and safety of two different defibrillators
  2. To investigate the effects of excessive oxygen on injury of the heart following cardioversion.

Experimental design:

Patients will be recruited at the outpatient clinic at the Department of Cardiology, Regional Hospital of Randers, Denmark as a part of the pre-cardioversion check.

Patients will be randomized to cardioversion using one of two defibrillators and randomized to treatment with room air or 100% oxygen.

The cardiac condition will be measured by blood samples before cardioversion, 4 hours after cardioversion and 3 months after cardioversion. Heart rhythm will be measured by ECG before cardioversion, 1 minute-, 30 minutes- and 4 hours after cardioversion.

详细描述

Background:

Treatment of cardiac arrest includes effective chest compressions, ventilation using high flow oxygen and the delivery of electric shocks (cardioversion). Prompt termination of cardiac arrhythmias and sufficient airway handling including oxygenation are crucial factors for patient outcome. Studies suggest that cardioversion itself may induce myocardial injury; however it is currently unknown whether hyperoxia exacerbate this injury.

Currently, several different biphasic waveforms are in use for cardioversion.The comparative efficacy and safety of these waveforms has not been compared in clinical studies. Commercially available defibrillators use different electrical waveforms that may affect the efficacy of external defibrillation. Although the superiority of biphasic over monophasic waveforms is well established, the relative efficacy and safety of the available biphasic waveforms is not clear.

The long held belief that oxygen (O2) is always beneficial for ill and injured patients is being challenged by recent studies suggesting that excessive oxygenation may result in free-radical mediated tissue damage, resulting in increased morbidity and mortality. Recent guidelines suggest that O2 should be 'titrated' to achieve an appropriate target saturation of 94-98% rather than being administered in an all-or-nothing fashion, particularly in patients with myocardial ischemia or those following resuscitation from cardiac arrest. The Scottish Intercollegiate Guidelines Network (SIGN), British Thoracic Society, National Institute of Health Care Excellence (NICE), European Resuscitation Council and other respected bodies all restrict O2 use to those with hypoxemia, pulmonary oedema or continuing myocardial ischemia, based on expert opinion and pathophysiological reasoning rather than hard evidence.

Studies using patients presenting with shockable life-threatening arrhythmias (e.g. ventricular fibrillation) are difficult to perform for ethical and practical reasons. This study will therefore use patients requiring elective cardioversion for atrial arrhythmias, who are able to give consent and also present a more controlled population. Elective cardioversion is a standard treatment for patients with atrial arrhythmias and is performed as a day case procedure under general anaesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Atrial fibrillation or -flutter

排除标准

  • Patients <18 years of age
  • Pregnancy
  • Haemodynamically unstable patients
  • Other arrhythmias
  • Untreated hyperthyroidism

研究组 & 干预措施

1 ("Standard": Oxygen / LIFEPAK 20)

Experimental
  1. Intervention: Cardioversion with a biphasic truncated exponential waveform
  2. Intervention: Hyperoxia during cardioversion

干预措施: Cardioversion with a biphasic truncated exponential waveform (Device)

1 ("Standard": Oxygen / LIFEPAK 20)

Experimental
  1. Intervention: Cardioversion with a biphasic truncated exponential waveform
  2. Intervention: Hyperoxia during cardioversion

干预措施: Hyperoxia during cardioversion (Procedure)

2 (room air / LIFEPAK 20)

Active Comparator
  1. Intervention: Cardioversion with a biphasic truncated exponential waveform
  2. Intervention: Normoxia during cardioversion

干预措施: Normoxia during cardioversion (Procedure)

2 (room air / LIFEPAK 20)

Active Comparator
  1. Intervention: Cardioversion with a biphasic truncated exponential waveform
  2. Intervention: Normoxia during cardioversion

干预措施: Cardioversion with a biphasic truncated exponential waveform (Device)

3 (Oxygen / Schiller Defigard 5000)

Active Comparator
  1. Intervention: Cardioversion with a pulsed biphasic waveform
  2. Intervention: Hyperoxia during cardioversion

干预措施: Cardioversion with a pulsed biphasic waveform (Device)

3 (Oxygen / Schiller Defigard 5000)

Active Comparator
  1. Intervention: Cardioversion with a pulsed biphasic waveform
  2. Intervention: Hyperoxia during cardioversion

干预措施: Hyperoxia during cardioversion (Procedure)

4 (Room air / Schiller Defigard 5000)

Active Comparator
  1. Intervention: Cardioversion with a pulsed biphasic waveform
  2. Intervention: Normoxia during cardioversion

干预措施: Cardioversion with a pulsed biphasic waveform (Device)

4 (Room air / Schiller Defigard 5000)

Active Comparator
  1. Intervention: Cardioversion with a pulsed biphasic waveform
  2. Intervention: Normoxia during cardioversion

干预措施: Normoxia during cardioversion (Procedure)

结局指标

主要结局

Defibrillator Efficiency: Proportion of patients in sinus rhythm four hours post cardioversion

时间窗: Heart rhythm measured four hours after cardioversion

Proportion of patients in sinus rhythm four hours post cardioversion

Change in Hs-cTnI and Hs-cTnT for room air versus hyperoxia

时间窗: Change measured from 2 hours before and 4 hours after cardioversion

High sensitive cardiac Troponin I (Hs-cTnI) and -T (Hs-cTnT) are biomarkers for myocardial injury. Cardiac troponins are measured in plasma as ng/L. Change in cardiac troponins (4 hours after cardioversion - pre-cardioversion) will be compared between room air and hyperoxia.

次要结局

  • Cardiac rhythm and change in biomarkers(Biomarkers will be measured within 2 hours before, 4 hours after and 3 months after cardioversion. ECG will be recorded after 1 minute, 30 minutes and four hours after cardioversion.)
  • Echocardiography(Performed at baseline, 2-4 hours after and 3 months following cardioversion)

研究者

发起方
Randers Regional Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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