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Pulse 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
Spry Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypoxia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
January 2, 2019
Last Updated
January 7, 2019
Sponsor
Spry Health
Collaborators
University of California, San Francisco
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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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