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

NCT02247765 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-05-05

Study results available
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Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Eric Heyer, MD · Medtronic - MITG

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2014-11-30
Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02247765 on ClinicalTrials.gov