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Post Market Clinical Follow Up of Skanray s Patient Monitors

A prospective, post market, non-interventional observational, open label, single arm, single center study to confirm the clinical safety and performance of Skanray’s Patient Monitors

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/05/042811
Enrollment
80
Registered
2022-05-25
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: 4- Measurement and Monitoring

Interventions

Intervention1: NA: NA Control Intervention1: NA: NA

Sponsors

Skanray Technologies Limited
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Collection of feedback reflecting the usability and design features from users. Collection of evidence reflecting the monitored parameters. Timepoint: Every 7th day or earlier

Countries

India

Contacts

Public ContactVasundhara R

Narayana Health MICU Mazumdar Shaw Medical Center

chethananudeeps@gmail.com9599204215

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026