Skip to content

Clinical Investigation of New Pulseoxymetry Device

"Pulse Oximetry(SpO2) Device OXYSKANs Accuracy Study as Compared to standard Device: Controlled Desaturation study of OXYSKAN" - OXYSKAN

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037193
Enrollment
25
Registered
2021-10-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: controlled desaturation study: Controlled De-saturation was carried out to compare new device with reference device. Intervention was given once. Intervention was given for maximum dura

Sponsors

Skanray India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Non-smokers 2) Healthy; no known blood disorders 3) Finger sizes within the sensor specifications 4) Minimum 18 years of age 5) Hb > 10 g/dl

Exclusion criteria

Exclusion criteria: 1) Artificial nails or fingernail polish 2) Subjects who would be placed at undue medical RISK associated with any PROCEDURES called for in the protocol; a previous or current diagnosis of anemia, asthma, heart/circulatory disease, high blood pressure, emphysema, or an epilepsy or seizure disorder 3) Being diagnosed with pneumonia during the previous year 4) Being a habitual tobacco smoker 5) Having lived at altitudes above 5,000 ft three months prior to being enrolled 6) History of having Claustrophobia 7) Pregnant Female 8) History of alcohol intake in last 48 hours

Design outcomes

Primary

MeasureTime frame
Primary Outcome Measures: 1. To Pulseoximetry values as measured using OXYSKAN device before, during and after the controlled desaturation.Timepoint: 1. Pulse oximetry values using OXYSKAN before, during and after controlled desaturation.

Secondary

MeasureTime frame
Secondary Outcome Measures: 1. To record comparative accuracy data pulseoximetre OXYSKAN with given standard deviceTimepoint: 1. Pulseoximetry values as measured simultaneously using OXYSKAN and given standard device before, during and after the controlled desaturation.

Countries

India

Contacts

Public ContactPRADIP B BARDE

Maharashtra University of health Sciences, Nashik

bardepb@drvasantraopawarmedicalcollege.com9021416946

Outcome results

None listed

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