Back to resultsPulse Oximeter Motion Study (Motion)
Primary Purpose
Hypoxia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motion
Sponsored by
About this trial
This is an interventional other trial for Hypoxia
Eligibility Criteria
Inclusion Criteria: healthy adult English speaking -
Exclusion Criteria: pediatric, cardiac or pulmonary condition. non-english speaking
-
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
motion
Arm Description
Right hand performs three different motion types
Outcomes
Primary Outcome Measures
Pulse oximetry reading
Secondary Outcome Measures
Arterial Blood gas
Full Information
NCT ID
NCT03156140
First Posted
May 15, 2017
Last Updated
May 15, 2017
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT03156140
Brief Title
Pulse Oximeter Motion Study
Acronym
Motion
Official Title
Four Types of Pulse Oximeters Accurately Detect Hypoxia During Low Perfusion and Motion
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
August 31, 2016 (Actual)
Study Completion Date
August 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
motion
Arm Type
Experimental
Arm Description
Right hand performs three different motion types
Intervention Type
Other
Intervention Name(s)
Motion
Intervention Description
Volunteer has motion on right hand while with continuous pulse oximetry during three oxygenation plateaus
Primary Outcome Measure Information:
Title
Pulse oximetry reading
Time Frame
immediate
Secondary Outcome Measure Information:
Title
Arterial Blood gas
Time Frame
immediate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy adult English speaking -
Exclusion Criteria: pediatric, cardiac or pulmonary condition. non-english speaking
-
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pulse Oximeter Motion Study
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