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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03534271
Enrollment
47
Registered
2018-05-23
Start date
2018-04-27
Completion date
2019-08-01
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oximetry

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.

Interventions

DEVICEiPhone with Kenek Edge and Samsung S8

Smartphones with pulse oximetry and heart rate monitoring capabilities

Sponsors

Rush University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of Smartphone Pulse Oximetersimmediately after the 6 minute walk testAccuracy of smartphone pulse oximeter after 6 minute walk Posttest SpO2 %

Countries

United States

Participant flow

Pre-assignment details

All 47 subjects that started the study, completed the study

Participants by arm

ArmCount
Six Minute Walk Group
Patients undergoing a six minute walk
47
Total47

Baseline characteristics

CharacteristicSix Minute Walk Group
Age69 years
Age, Customized
Age >=18 years
47 years
Race/Ethnicity, Customized
Asian
NA participants
Race/Ethnicity, Customized
Black/African American
NA participants
Race/Ethnicity, Customized
Hispanic/Latinx
NA participants
Race/Ethnicity, Customized
White/Caucasian
NA participants
Region of Enrollment
United States
47 participants
Sex: Female, Male
Female
36 Participants
Sex: Female, Male
Male
11 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 47
other
Total, other adverse events
0 / 47
serious
Total, serious adverse events
0 / 47

Outcome results

Primary

Accuracy of Smartphone Pulse Oximeters

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

Time frame: immediately after the 6 minute walk test

Population: all participants

ArmMeasureValue (MEDIAN)
All SubjectsAccuracy of Smartphone Pulse Oximeters98 percentage of oxygen saturation

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026