Post Market Clinical Follow Up of Skanray s Patient Monitors
Phase 4
Completed
- Conditions
- Health Condition 1: 4- Measurement and Monitoring
- Registration Number
- CTRI/2022/05/042811
- Lead Sponsor
- Skanray Technologies Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Adult, pediatric and neonatal subjects of either genders.
The patients who need continuous physiological parameters monitoring in different areas of the hospital (Ex; ICU, OT, emergency, wards, operative care etc.)
The subjects or the legally authorised representative capable of understanding and signing the informed consent.
Exclusion Criteria
Subjects who are to be monitored in an MRI environment or in an oxygen-enriched environment.
Neonates shall be excluded for ST segment and arrhythmia analysis.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Continuous monitoring of vital physiological parameters such as ECG 3 5 12 lead, arrhythmia & ST analysis, respiration rate, non invasive blood pressure, invasive blood pressure, temperature, SpO2, end tidal CO2, cardiac output, non-invasive cardiac output and anesthesia gas monitoring.Timepoint: Every 1 hours
- Secondary Outcome Measures
Name Time Method Collection of feedback reflecting the usability and design features from users. <br/ ><br>Collection of evidence reflecting the monitored parameters. <br/ ><br>Timepoint: Every 7th day or earlier