Pulse Oximeter and Respiratory Rate Test

January 7, 2019 updated by: Spry Health

Accuracy of Pulse Oximeters With Profound Hypoxia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF Hypoxia Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adult willing to participate

Exclusion Criteria:

  • Wrist size outside the indicated use
  • Low perfusion
  • Smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Primary
Device: Spry Loop Band
Loop band measures pulse oximetry and respiration rate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of SpO2 measurement
Time Frame: duration of subject monitoring, usually up to one hour
Pulse oximetry measurement accuracy vs. gold standard
duration of subject monitoring, usually up to one hour
Accuracy of Respiratory Rate measurement
Time Frame: duration of subject monitoring, usually up to one hour
Respiratory rate measurement accuracy vs. gold standard
duration of subject monitoring, usually up to one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spry Health

Collaborators

University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2018

Primary Completion (Actual)

December 14, 2018

Study Completion (Actual)

December 14, 2018

Study Registration Dates

First Submitted

January 2, 2019

First Submitted That Met QC Criteria

January 7, 2019

First Posted (Actual)

January 9, 2019

Study Record Updates

Last Update Posted (Actual)

January 9, 2019

Last Update Submitted That Met QC Criteria

January 7, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SpryUCSF2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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