A prospective, post-market clinical data analysis in patients undergoing cardioversion ordefibrillation using Skanrays Defibrillators
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- To collect clinical data of patients undergoing defibrillation, cardioversion or pacing using
研究概览
简要总结
Skanray’s Defibrillators are portable external defibrillator with manual or semi automatic control along with pacing and monitoring of ECG, SpO2 (optional) and NiBP (optional). It employs bi-phasic current or duration controlled shock waveform. The Skanray’s Defibrillators defibrillator / monitor is used for the treatment of life threatening cardiac dysrhythmias by qualified medical personnel familiarised in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation, in a professional healthcare facility under controlled environment. Indicated for manual defibrillation therapy, semi-AED therapy and pacing therapy. This device is approved by European CE and CDSCO (DCGI).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Data from the subject that meets the below-mentioned criteria shall be collected.
- •â— Patients with indications for defibrillation/cardioversion/pacing.
- •â— Male and female subjects who weigh above 10 kg.
排除标准
- •â— Unsafe conditions or surroundings for the use of Direct Current â— Contraindications for defibrillation A A responsive patient with spontaneous breathing and a palpable pulse. B Asystole or pulseless electrical activity PEA â— Contraindications for cardioversion.
- •arrhythmias due to enhanced automaticity, such as digitalis toxicity of digitalis-associated tachycardia, sinus tachycardia, multifocal atrial tachycardia and junctional tachycardia. Catecholamine-induced arrhythmia having a homogeneous depolarization state Eg CPVT, shall be excluded. â— Contraindications for pacing.
- •asymptomatic subjects with a reasonably stable rhythm.
结局指标
主要结局
To collect clinical data of patients undergoing defibrillation, cardioversion or pacing using
时间窗: Within 1 day.
Skanrays Defibrillators.
时间窗: Within 1 day.
次要结局
- To collect the following data with the use of Skanray defibrillators(a. Clinical feedback from the investigator.)