OximetryNCT03534271

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

An observational study of Oximetry, run by Rush University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Oximetry
What is being tested?: iPhone with Kenek Edge and Samsung S8
Type of treatment: Medical device
How many people: 47 participants
Where: 1 siteUnited States
Study dates: 27 Apr 2018to 1 Aug 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Rush University Medical Center
Chicago, Illinois, 60187

Other trials in United States

About this study

Conditions: Oximetry
Being tested: iPhone with Kenek Edge and Samsung S8

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

iPhone with Kenek Edge and Samsung S8Device
Smartphones with pulse oximetry and heart rate monitoring capabilities

What is being measured

The primary outcome is the main question the study is designed to answer.

Accuracy of Smartphone Pulse Oximeters
Accuracy of smartphone pulse oximeter after 6 minute walk Posttest SpO2 %
Measured: immediately after the 6 minute walk test

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Apr 20181 Aug 2019

First posted23 May 2018
Study start27 Apr 2018
Primary completion1 Aug 2019
Study completion1 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for OximetryStudies of the same condition, open and under way.
More trials run by Rush University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03534271
Sponsor's protocol ID: 18022702
Status last verified: May 2023
First submitted: 8 May 2018
Last updated: 5 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 33023999

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia
Not yet recruiting
Effect of Nurse-Directed Therapeutic Positioning in Children With Pneumonia
Pediatric Pneumonia
Enrolling by invitationObservational study
ETCO₂ Targeting and Cerebral Oxygenation
Airway Reactivity, Hemodynamic Stability During Anesthesia

All Oximetry trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Accuracy of Smartphone Pulse Oximetry in Patients Visiting an Outpatient Pulmonary Function Lab for a 6-Minute Walk Test
ClinicalTrials.gov ID: NCT03534271
Acronym / sponsor ID: 18022702
Conditions: Oximetry
Study type: Observational
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Rush University Medical CenterUniversity, hospital or other
Study start: 27 Apr 2018 (actual)
Primary completion: 1 Aug 2019 (actual)
Study completion: 1 Aug 2019 (actual)
First posted: 23 May 2018 (actual)
Results: Posted 5 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult
Study population: Patients visiting a pulmonary function lab for 6-minute walk test

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
iPhone with Kenek Edge and Samsung S8Smartphones with pulse oximetry and heart rate monitoring capabilities	Device	–

Primary outcome

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 %

Results and safety

Results posted to the registry on 5 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Six Minute Walk Group	47	47

Primary outcome: Accuracy of Smartphone Pulse Oximeters

Time frame: immediately after the 6 minute walk test. Median (Inter-Quartile Range). Unit: percentage of oxygen saturation

Measure	All Subjects n = 47
Value	98 (96 to 99)

Population analysed: all participants

Adverse events

Time frame: While each subject participated in the study. No follow up was made.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Six Minute Walk Group	0 of 47 (0%)	0 of 47 (0%)	0 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33023999Modi 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.

Related trials for Oximetry

Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia
Not yet recruiting
Effect of Nurse-Directed Therapeutic Positioning in Children With Pneumonia
Pediatric Pneumonia
Enrolling by invitationObservational study
ETCO₂ Targeting and Cerebral Oxygenation
Airway Reactivity, Hemodynamic Stability During Anesthesia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Oximetry, run by Rush University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of Smartphone Pulse Oximeters (time frame: immediately after the 6 minute walk test). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03534271, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.