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Controlled Acute Hypoxia Study - Abbreviated Sensor Line

Healthy Clinical Trial

Official title:
Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples Using the Abbreviated Sensor Line in Healthy Subjects With the USB Pulse Oximetry Monitor Interface Cable

Clinical Trial Summary

The primary objective of the study is to validate the proposed claims for the OxiCable device, for pulse rate and saturation accuracy in a diverse subject population over a specified saturation range.

Clinical Trial Description

The general procedure of invasive controlled hypoxia clinical studies is to directly compare test pulse oximeter measurements to saturation measurements made by a multi-wavelength CO-oximeter taken from arterial blood samples from healthy human subjects. Following arterial cannulation, hypoxia is induced by reducing the percent of inspired oxygen the subject breathes while simultaneous measurements are recorded from the test pulse oximeters and arterial blood samples at targeted levels of saturation. ;

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02216344
Study type Observational
Source Medtronic - MITG
Contact
Status Completed
Phase N/A
Start date August 2014
Completion date September 2014
View Details
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