Back to resultsPulse Oximeter and Respiratory Rate Test
Primary Purpose
Hypoxia, Hypercapnia, Hypocapnia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spry Loop Band
Sponsored by
About this trial
This is an interventional basic science trial for Hypoxia
Eligibility Criteria
Inclusion Criteria:
- Healthy adult willing to participate
Exclusion Criteria:
- Wrist size outside the indicated use
- Low perfusion
- Smoking
Sites / Locations
- UCSF Hypoxia Lab
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Primary
Arm Description
Outcomes
Primary Outcome Measures
Accuracy of SpO2 measurement
Pulse oximetry measurement accuracy vs. gold standard
Accuracy of Respiratory Rate measurement
Respiratory rate measurement accuracy vs. gold standard
Secondary Outcome Measures
Full Information
NCT ID
NCT03797300
First Posted
January 2, 2019
Last Updated
January 7, 2019
Sponsor
Spry Health
Collaborators
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT03797300
Brief Title
Pulse Oximeter and Respiratory Rate Test
Official Title
Accuracy of Pulse Oximeters With Profound Hypoxia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 12, 2018 (Actual)
Primary Completion Date
December 14, 2018 (Actual)
Study Completion Date
December 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spry Health
Collaborators
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assessment of Spry Health's Loop oximetry accuracy in profound hypoxia Assessment of Spry Health's Respiratory rate accuracy in normal conditions and profound hypoxia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Hypercapnia, Hypocapnia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Primary
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Spry Loop Band
Intervention Description
Loop band measures pulse oximetry and respiration rate
Primary Outcome Measure Information:
Title
Accuracy of SpO2 measurement
Description
Pulse oximetry measurement accuracy vs. gold standard
Time Frame
duration of subject monitoring, usually up to one hour
Title
Accuracy of Respiratory Rate measurement
Description
Respiratory rate measurement accuracy vs. gold standard
Time Frame
duration of subject monitoring, usually up to one hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adult willing to participate
Exclusion Criteria:
Wrist size outside the indicated use
Low perfusion
Smoking
Facility Information:
Facility Name
UCSF Hypoxia Lab
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Pulse Oximeter and Respiratory Rate Test
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