NCT02247765

Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion

Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion in Healthy, Well Perfused Subjects With the USB Pulse Oximetry Monitor Interface Cable

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

To validate the proposed claims for pulse rate and saturation accuracy in a diverse subject population during motion over a specified saturation range.

Detailed description

Use an investigational oximetry system to evaluate the triggering of the "sensor off" status with marketed, off-the-shelf sensors.

Conditions

• Healthy
• Hypoxia

Interventions

Type	Name	Description
DEVICE	Arterial line	Arterial line is inserted to draw a CO-Oximeter value as it is the gold standard and as advised in ISO 80601
DEVICE	Motion	The subject is asked to move their hand by either rubbing or tapping their fingers at a specified frequency and amplitude during portions of the hypoxic procedure.

Timeline

• Start date: 2014-11-01
• Primary completion: 2014-11-01
• Completion: 2014-12-01
• First posted: 2014-09-25
• Last updated: 2017-05-05
• Results posted: 2017-05-05

Locations

2 sites across 1 country: United States