NCT05466942

RDS MultiSense® SpO2 Calibration

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Rhythm Diagnostic Systems · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Data will be collected with the MultiSense® pulse oximetry system during non-motion conditions over the range of 70-100%. A Clinimark reference system, previously correlated to arterial blood CO-Oximetry will be the basis for comparison. A minimum of fifteen (15) up to fifty (50) healthy adult subjects, ranging in pigmentation from light to dark, with at least six (6) subjects with dark pigmentation (Fitzpatrick 5-6), will be enrolled in the study to meet the study design requirements defined by ISO 80601-2-61 and by the FDA's Guidance for Pulse Oximeters (March 4, 2013). SpO2 data will be evaluated during non-motion conditions. SpO2 data will be evaluated during stable step plateaus of induced hypoxic levels. The investigational device will be placed on the thorax of the subjects (patch on the upper back and external electrode on the right pectoral). Simultaneous data collection will be set up for the reference and the systems under test.

Conditions

• Hypoxia

Interventions

Type	Name	Description
DEVICE	Pulse Oximeter, Respiratory Rate, Heart Rate	Measurement of physiological parameters

Timeline

• Start date: 2022-03-15
• Primary completion: 2022-03-17
• Completion: 2022-10-20
• First posted: 2022-07-20
• Last updated: 2024-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study