NCT04324385

Brief Summary

To test the accuracy of a non-invasive blood oxygen saturation monitor which is placed on a subject with profound hypoxia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2019

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

1 day

First QC Date

March 23, 2020

Last Update Submit

March 25, 2020

Conditions

Oximetry

Outcome Measures

Primary Outcomes (1)

  • Testing the accuracy of a new pulse oximeter device

    The primary outcome measure was to find the agreement between methods of measurement with multiple observations per individual. Spo2 readings from the test device were compared with a factory certified and calibrated oxyhemoglobin saturation monitor (i.e. ABL-90 multi-wavelength oxiemter) and two other standard oximeter devices using root mean squared error as the measure of accuracy.

    Approx. 60 mins per subject

Eligibility Criteria

Age21 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All of the subjects enrolled in the study had normal hemoglobin levels (Hemoglobin ≤ 10gm•dl-1) and all were healthy non-smoking individuals of age 21-49.

You may qualify if:

  • Normal hemoglobin levels (Hemoglobin ≤ 10gm•dl-1)
  • Healthy
  • Non-smoking individuals

You may not qualify if:

  • Unhealthy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hypoxia Lab

San Francisco, California, 94143, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 27, 2020

Study Start

April 9, 2019

Primary Completion

April 10, 2019

Study Completion

April 10, 2019

Last Updated

March 27, 2020

Record last verified: 2020-03

Locations

US(1)