Signs and SymptomsNCT02482779
Smartphone Application-Based Vital Sign Monitors
An observational study of Signs and Symptoms, run by University of Texas Southwestern Medical Center.
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.
- Conditions
- Signs and Symptoms
- Medical subject headings
- Signs and Symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted26 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Signs and SymptomsStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Alexander, University of Texas Southwestern Medical Center
- Investigators
- John Alexander, MD, Principal investigator, UT Southwstern Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Smartphone Application-Based Vital Sign Monitors to Devices Used in Clinical Practice
- ClinicalTrials.gov ID
- NCT02482779
- Acronym / sponsor ID
- 082014-039
- Conditions
- Signs and Symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers from the UT Southwestern Department of Anesthesiology \& Pain Management
Key inclusion criteria (1 listed)
- Volunteers from the UT Southwestern Department of Anesthesiology \& Pain Management
Key exclusion criteria (4 listed)
- History of Hypertension,
- History of Cardiac Disease,
- History of Peripheral Vascular Disease
- History of Upper extremity amputation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood Pressure
Time frame: Measurements of blood pressure within approximately 15 to 45 minutes.
A series of blood pressure measurements with apps following standard monitor.
1 secondary outcome
Blood Pressure
Time frame: Measurements of blood pressure within approximately 15 to 45 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Background: PubMed 27170014Alexander 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.
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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.
John Alexander, MD principal investigator
UT Southwstern Medical Center
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.