NCT03534271

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

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 27, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

February 5, 2024

Completed
Last Updated

February 5, 2024

Status Verified

May 1, 2023

Enrollment Period

1.3 years

First QC Date

May 8, 2018

Results QC Date

March 16, 2022

Last Update Submit

May 25, 2023

Conditions

Oximetry

Outcome Measures

Primary Outcomes (1)

  • Accuracy of Smartphone Pulse Oximeters

    Accuracy of smartphone pulse oximeter after 6 minute walk Posttest SpO2 %

    immediately after the 6 minute walk test

Interventions

iPhone with Kenek Edge and Samsung S8DEVICE

Smartphones with pulse oximetry and heart rate monitoring capabilities

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60187, United States

Location

Related Publications (1)

  • Modi AM, Kiourkas RD, Li J, Scott JB. Reliability of Smartphone Pulse Oximetry in Subjects at Risk for Hypoxemia. Respir Care. 2021 Mar;66(3):384-390. doi: 10.4187/respcare.07670. Epub 2020 Oct 6.

    PMID: 33023999DERIVED

Results Point of Contact

Title
Dr. Jonathan Brady Scott
Organization
Rush University
jonathan_b_scott@rush.edu
3129426389

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Director of Clinical Education

Study Record Dates

First Submitted

May 8, 2018

First Posted

May 23, 2018

Study Start

April 27, 2018

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

February 5, 2024

Results First Posted

February 5, 2024

Record last verified: 2023-05

Locations

US(1)