Post-Market Clinical Data Analysis With Skanrays Defibrillators (Clinical study to record the safety and performance data of Skanrays Defibrillators in real world scenario)
- Registration Number
- CTRI/2023/05/053279
- Lead Sponsor
- Skanray Technologies Limited
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 65
- 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.
- 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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To collect clinical data of patients undergoing defibrillation, cardioversion or pacing using Within 1 day. Skanrays Defibrillators. Within 1 day.
- Secondary Outcome Measures
Name Time Method To collect the following data with the use of Skanray defibrillators a. Clinical feedback from the investigator.
Trial Locations
- Locations (1)
JSS Hospital
🇮🇳Mysore, KARNATAKA, India
JSS Hospital🇮🇳Mysore, KARNATAKA, IndiaDr Manjappa MahadevappaPrincipal investigator7899584676manjappam@jssuni.edu.in