Smartphone Application-Based Vital Sign Monitors

NCT02482779 | Completed

• 1 other identifier: 082014-039
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Signs and Symptoms

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

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

  Measurements of blood pressure within approximately 15 to 45 minutes.

Secondary Outcomes (1)

• Blood Pressure

  Measurements of blood pressure within approximately 15 to 45 minutes.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Related Publications (1)

• 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.

  PMID: 27170014 BACKGROUND

MeSH Terms

Conditions

Signs and Symptoms

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

• John Alexander, MD

  UT Southwstern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: June 26, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 20, 2023

Record last verified: 2023-12