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Signs and SymptomsNCT02482779

Smartphone Application-Based Vital Sign Monitors

An observational study of Signs and Symptoms, run by University of Texas Southwestern Medical Center.

Completed

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

Official record
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Trial summary

Health-related applications for smartphones represent a new and popular market for consumer oriented products. These applications are generally not considered medical devices and, as such, are not under the purview of the Federal Drug Administration. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Signs and Symptoms
How many people
120 participants
Where
No sites listed yet
Study dates
Jan 2015to Jul 2015
Phase
Observational
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Volunteers from the UT Southwestern Department of Anesthesiology \& Pain Management

Who may be able to join

  • Volunteers from the UT Southwestern Department of Anesthesiology \& Pain Management

Who cannot join

  • History of Hypertension,
  • History of Cardiac Disease,
  • History of Peripheral Vascular Disease
  • History of Upper extremity amputation

About this study

Official title: Comparison of Smartphone Application-Based Vital Sign Monitors to Devices Used in Clinical Practice

Health-related applications for smartphones represent a new and popular market for consumer oriented products. These applications are generally not considered medical devices and, as such, are not under the purview of the Federal Drug Administration. Some of these applications purport to measure vital signs, but do not have any published data to confirm accuracy of such measurements and their developers have not been willing to divulge the methods by which vital sign readings are produced.

Use of unvalidated application derived data may contribute to patient harm as patients may make healthcare decisions based on the results these applications provide. This study aims to assess the accuracy of several such applications by comparing their findings to those of clinical vital sign monitors commonly used in the perioperative setting.

Read the detailed description

Recruitment of volunteers take place via announcement at the Anesthesiology Departmental Grand Rounds as well as by flyers posted in the UT Southwestern Department of Anesthesiology \& Pain Management.

After verbal consent is obtained, each volunteer will be placed in the seated position. Upper-arm non-invasive blood pressure will be measured using WelchAllyn Propaq CS via a standard size cuff placed in the standard fashion between the elbow and shoulder. Pulse oximetry measurement will be obtained using the WelchAllyn Propaq CS via the 4th digit of the hand.

The smart phone applications are Instant Blood Pressure, Instant Blood Pressure Pro, Pulse Oximeter and Pulse Oximeter Pro and purchased by the principal investigator and downloaded via the iTunes App Store onto an iPhone 5S with iOS 7.1.2 owned by the principal investigator. The application-based measurements will be performed by the volunteer according to the instructions from the application to the user without explanation from the investigators.

Systolic blood pressure (SBP), diastolic blood pressure (SBP), pulse (P) and peripheral capillary oxygen saturation (SpO2) will be collected from 100 volunteers. Serial measurements will be taken in the following fashion: right upper extremity, smartphone application measurements, left upper extremity and repeat smartphone application measurements. Thus, for each volunteer each data point referenced above will be recorded six times: two times using standard equipment readings (one per extremity) and four times with application-based readings (two times per application).

The two applications to measure blood pressure (Instant Blood Pressure and Instant Blood Pressure Pro) both utilize the camera and flashlight on the iPhone. In addition, the Instant Blood Pressure application also utilizes the microphone and instructs the user to hold the iPhone against the chest in a specific fashion to complete its measurement. Both applications also request the user to input certain demographic data: Gender, Age, Height and Weight. In addition, one application (Instant Blood Pressure Pro) also instructs the user to input data on "Body Condition" and provides the following options: Poor, Below Average, Average, Above Average, Good, Excellent and Athlete. The application does not provide any direction on how one is to distinguish between these options. If these applications measure data based on some yet unexplained function using the iPhone's onboard technology, then changing the demographic data should not alter the result of the measurement. In the same way, a sphygmomanometer or pulse oximeter does not need to know one's gender, height, weight or age to accurately measure blood pressure or pulse.

The application based vital sign readings may change in concert with changes to demographic variables even though clinical vital sign monitors remain relatively consistent. To test this hypothesis, in a subgroup (n=20), serial measurements using both clinical vital sign and application based vital sign readings will be evaluated by changing demographic variables in the application based vital sign monitors.

For this subgroup the volunteer will perform serial measurements with the following changes in demographic data for each application: Correct data, Age + 10, Age + 20, Age - 10, Age - 20, Weight - 10%, Weight - 25%, Weight + 10% and Weight +25%. Additionally, for the Instant Blood Pressure Pro application additional readings will be taken changing the "Body Condition" demographic as follows: Poor, Average, Good and Athlete. For each measurement taken using the applications another will be taken using the clinical monitor, or thirteen total readings per volunteer.

Medical subject headings
Signs and Symptoms

What is being measured

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

  1. Blood Pressure

    A series of blood pressure measurements with apps following standard monitor.

    Measured: Measurements of blood pressure within approximately 15 to 45 minutes.

Secondary outcomes (1)
  1. Blood Pressure

    A series of blood pressure measurements with apps before and after demographic information changes.

    Measured: Measurements of blood pressure within approximately 15 to 45 minutes.

Timeline

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

  1. First posted26 Jun 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionJun 2015
  4. Study completionJul 2015

Resources

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
Other
Time perspective
Prospective
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02482779
Sponsor's protocol ID
082014-039
Status last verified
Dec 2023
First submitted
22 Jun 2015
Last updated
20 Dec 2023
Results posted
No
Data monitoring committee
No

Publications

  • Alexander JC, Minhajuddin A, Joshi GP. Comparison of smartphone application-based vital sign monitors without external hardware versus those used in clinical practice: a prospective trial. J Clin Monit Comput. 2017 Aug;31(4):825-831. doi: 10.1007/s10877-016-9889-6. Epub 2016 May 12.

    PubMed 27170014

Questions about this trial

What is this clinical trial studying?

An observational study of Signs and Symptoms, run by University of Texas Southwestern Medical Center.

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 1 inclusion and 4 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 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Blood Pressure (time frame: Measurements of blood pressure within approximately 15 to 45 minutes.). 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 NCT02482779, 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 20 Dec 2023.

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