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NCT03156140 Clinical Trial

Pulse Oximeter Motion Study

Hypoxia Clinical Trial

— Motion  

Official title:
Four Types of Pulse Oximeters Accurately Detect Hypoxia During Low Perfusion and Motion

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03156140
Other study ID # Pulse Motion
Secondary ID
Status Completed
Phase N/A
First received May 15, 2017
Last updated May 15, 2017
Start date June 1, 2016
Est. completion date August 31, 2016

Study information
Verified date May 2017
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluate the performance of 4 pulse oximeters in 10 healthy adult volunteers with three motions compared to non-motion control at three arterial oxygen saturation target plateaus.

Description:

Evaluate the performance of 4 pulse oximeters (Masimo Radical-7, Nihon-Koden OxyPal Neo, Nellcor N-600, and Philips Intellivue MP5) in 10 healthy adult volunteers. Three motions will be evaluated: tapping, pseudorandom, and volunteer-generated rubbing, adjusted to produce photoplethsmogram disturbance similar to arterial pulsation amplitude. During motion, inspired gases will be adjusted to achieve stable target plateaus of arterial oxygen saturation (SaO2) at 75%, 88%, and 100%. Pulse oximeter readings (SpO2) will be compared with SaO2 from simultaneous arterial blood samples

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date August 31, 2016
Est. primary completion date August 31, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: healthy adult English speaking -

Exclusion Criteria: pediatric, cardiac or pulmonary condition. non-english speaking

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Motion
Volunteer has motion on right hand while with continuous pulse oximetry during three oxygenation plateaus

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Francisco

Outcome
Type Measure Description Time frame Safety issue
Primary Pulse oximetry reading immediate
Secondary Arterial Blood gas immediate
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