Pulse Oximeter and Respiratory Rate Test

Hypoxia Clinical Trial

Official title:

Accuracy of Pulse Oximeters With Profound Hypoxia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03797300
• Other study ID #: SpryUCSF2
• Status: Completed
• Phase: N/A
• Start date: December 12, 2018
• Est. completion date: December 14, 2018

Study information

• Verified date: January 2019
• Source: Spry Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 14, 2018
• Est. primary completion date: December 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy adult willing to participate

Exclusion Criteria:

• Wrist size outside the indicated use

• Low perfusion

• Smoking

Related Conditions & MeSH terms

• Hypercapnia
• Hypocapnia
• Hypoxia

Intervention

Device:
• Spry Loop Band
Loop band measures pulse oximetry and respiration rate

Locations

Country	Name	City	State
United States	UCSF Hypoxia Lab	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Spry Health	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of SpO2 measurement	Pulse oximetry measurement accuracy vs. gold standard	duration of subject monitoring, usually up to one hour
Primary	Accuracy of Respiratory Rate measurement	Respiratory rate measurement accuracy vs. gold standard	duration of subject monitoring, usually up to one hour