The Accuracy of Smartphone Pulse Oximetry in Patients Visiting an Outpatient Pulmonary Function Lab for a 6-Minute Walk Test

May 25, 2023 updated by: Brady Scott, Rush University Medical Center
The primary aim of this research is to determine the accuracy of smartphone pulse oximeters in detecting blood oxygen saturations, episodes of desaturations, and heart rate by comparing results to a Masimo© hospital-grade pulse oximeter.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

47

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
    • Illinois
      • Chicago, Illinois, United States, 60187
        • Rush University Medical Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients visiting a pulmonary function lab for 6-minute walk test

Description

Inclusion Criteria:

  • Ambulatory
  • 18 years and older
  • Visiting the pulmonary function laboratory at Rush University Medical Center for a 6-minute walk test that agree to participate.

Exclusion Criteria:

  • Under the age of 18 years
  • High blood pressure above 180/90 mm Hg or pressure below 70/50 mm Hg
  • Dizzy, lightheaded or have severe headaches at time of enrollment
  • SpO2 at or below 85% on supplemental oxygen
  • On oxygen greater than 4 liters per minute
  • Gait issues that may result in a fall or patient walks with a walker and did not bring the device to this visit

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of Smartphone Pulse Oximeters
Time Frame: immediately after the 6 minute walk test
Accuracy of smartphone pulse oximeter after 6 minute walk Posttest SpO2 %
immediately after the 6 minute walk test

Collaborators and Investigators

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

Sponsor

Rush University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 27, 2018

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

May 8, 2018

First Submitted That Met QC Criteria

May 21, 2018

First Posted (Actual)

May 23, 2018

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 18022702

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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