NCT03735329

Polso SpO2 Accuracy Validation Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: ChroniSense Medical Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to validate the oxygen saturation (SpO2) accuracy of the Polso Monitoring System during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation

Detailed description

The purpose of this study is to validate the SpO2 accuracy and performance of the Polso Monitoring System during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation. It is expected that the Accuracy Root Mean Square (Arms) performance of the Polso Monitoring System will meet a specification of 3.5% or less in non-motion conditions for the range of 70-100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification. The Control Pulse Oximeter, an FDA cleared device, is used to monitor the oxygen saturation levels real time throughout the study for subject safety and to target stable plateaus. This device is used to assess the stability of the data. A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study. A minimum of 10 healthy adult subjects, ranging in pigmentation from light to dark, will be enrolled in the study to meet the study design requirements defined by ISO 80601-2-61:2011 and by the FDA's Guidance for Pulse Oximeters. The subjects will have an arterial catheter placed in the radial artery to allow for simultaneous blood samples during stable plateaus of induced hypoxic levels. The study population will include 10-15 healthy non-smoking (or has refrained from smoking for 2 days) competent adults 18-50 years of age. The subject selection will be an equitable distribution of males and females of any race with varying skin tones including at least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger. Data collection will occur over a 2-5 day period for this study population.

Conditions

• Hypoxia

Interventions

Type	Name	Description
DEVICE	Diagnostic test of SPO2	The SpO2 accuracy of the test devices will be evaluated over the oxygen saturation range between 70-100%.

Timeline

• Start date: 2019-01-29
• Primary completion: 2019-01-31
• Completion: 2019-02-04
• First posted: 2018-11-08
• Last updated: 2019-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study