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Pulse Oximeter and Respiratory Rate Test

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ClinicalTrials.gov Identifier: NCT03797300
Recruitment Status : Completed
First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Spry Health

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

Condition or disease Intervention/treatment Phase
Hypoxia Hypercapnia Hypocapnia Device: Spry Loop Band Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Accuracy of Pulse Oximeters With Profound Hypoxia
Actual Study Start Date : December 12, 2018
Actual Primary Completion Date : December 14, 2018
Actual Study Completion Date : December 14, 2018

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




Primary Outcome Measures :
  1. Accuracy of SpO2 measurement [ Time Frame: duration of subject monitoring, usually up to one hour ]
    Pulse oximetry measurement accuracy vs. gold standard

  2. Accuracy of Respiratory Rate measurement [ Time Frame: duration of subject monitoring, usually up to one hour ]
    Respiratory rate measurement accuracy vs. gold standard



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult willing to participate

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03797300


Locations
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United States, California
UCSF Hypoxia Lab
San Francisco, California, United States, 94143
Sponsors and Collaborators
Spry Health
University of California, San Francisco

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Responsible Party: Spry Health
ClinicalTrials.gov Identifier: NCT03797300     History of Changes
Other Study ID Numbers: SpryUCSF2
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hypoxia
Hypercapnia
Hypocapnia
Signs and Symptoms, Respiratory
Signs and Symptoms