Evaluating the Accuracy of an Integrated Vital Sign Measurement Platform

Multimorbidity Clinical Trial

Official title:

Evaluating the Accuracy of an Integrated Vital Sign Measurement Platform

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03589716
• Other study ID #: 2018P000152
• Status: Completed
• Phase: N/A
• Start date: July 23, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: August 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Partners Connected Health will conduct a clinical validation study to evaluate the accuracy of measurement for each vital sign with the Vital Moto Mod platform, compared to appropriate reference devices used in the hospital setting. The study will recruit volunteers from the Partners Healthcare network of clinics and hospitals and the general public.

Description:

To assess the comparative clinical performance of the Vital Moto Mod device in the measurement of five vital signs (body temperature, respiratory rate, heart rate, oxygen saturation and blood pressure) in correlation with a reference device used in the hospital environment for vital sign measurement.

Vital sign measurement is a core process in delivering healthcare. Body temperature, respiratory rate, heart rate, oxygen saturation and blood pressure are some of the most frequently measured vital signs in inpatient as well as outpatient encounters. Currently, separate devices exist for measurement of each of these vital signs, each of which may have to be measured several times in a day. Consequently, measurement of vital signs is a time and human resource intensive process. Moreover, most of the devices currently used to measure vital signs cannot transmit data to the electronic medical record of patient, thereby creating opportunities for human error. VVVital USA has used proprietary sensor technology to develop Vital Moto Mod - a vital sign measurement platform that can non-invasively measure body temperature, respiratory rate, heart rate, oxygen saturation and blood pressure from a person's index finger, and allows this information to be pushed into their electronic medical/health record from the point of care

The primary market focus use of the Vital Moto Mod is to replace the vital sign cart in hospitals. Vital sign carts are expensive and cumbersome to move around the hospital. At a fraction of the cost, the Vital Moto Mod provides the same functionality including bar code scanning at a fraction of the cost. Additionally, the Vital Moto Mod can also be used at home without the need for a trained nurse. The Vital Moto Mod App will guide a user through the workflow of performing the measurements. The Vital Moto Mod is connected to a smartphone for storage, and has a USB interface for charging, thereby requiring no electrical connections during use. All measurements are taken by the device independent of the phone.

Partners Connected Health will conduct a clinical validation study to evaluate the accuracy of measurement for each vital sign with the Vital Moto Mod platform, compared to appropriate reference devices used in the hospital setting. The study will recruit volunteers from the Partners Healthcare network of clinics and hospitals and the general public.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: December 30, 2019
• Est. primary completion date: March 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

For volunteers with one or more vital signs presumed to be within normal physiological range, at rest:

• Age = 18 years

• Willing to allow arm and finger size to be measured

• Willing to allow measurement of skin color (optional)a

• Willing to undergo exercise testing (optional);

• Willing to allow an arterial blood gas draw (optional);

For volunteers with one or more vital signs expected to be outside of normal physiological range, at rest:

• Age=18 years

• Willing to allow arm and finger size to be measured

• Willing to allow measurement of skin color (optional)

Exclusion Criteria:

For Volunteers Undergoing Heart Rate and Oxygen Saturation Measurement:

• Nail paint or artificial nail on the index finger of the left hand

• SpO2 less than 94%

For Volunteers Undergoing Exercise Testing with Vital Signs within Normal Physiological Range, at rest:

• Volunteers with vital signs outside of normal physiological range (ascertained during measurements conducted at study site before exercise testing)

• Age 65 years or older

• Consumption of food, alcohol or caffeine (coffee, tea or caffeinated soft-drinks) in a 3-hour period prior to testing

• Uncomfortable clothing, or inappropriate footwear for exercise testing

• Self-report of any of the following:

• History of fall or fracture in the past year

• History of arthritis

• History of dizziness

• History of neurological illness

• History of chest pain or myocardial infarction

• History of hypertension or diabetes mellitus

• History of heart disease

• History of stroke or transient ischemic attack

• Active treatment for anemia, electrolyte imbalance, or hyperthyroidism

• Physical disability that precludes safe and adequate testing

• Mental impairment with limited ability to cooperate4

• Pregnancy (Volunteer will be excluded if either of the following is true: a) self-report of being pregnant; b) positive urine pregnancy test)

For Volunteers undergoing an Arterial Blood Gas Draw with Vital Signs within Normal Physiological Range, at rest:

• Self-reported history of a clotting disorder of the blood, or active treatment with medicines affecting blood clotting (e.g. Warfarin).

Related Conditions & MeSH terms

• Multimorbidity

Intervention

Other:
• Vital Moto Mod
All participants receive vital signs measurement using the Vital Moto Mod device and reference devices. The vital signs measured are blood pressure, heart rate, respiratory rate, oxygen saturation and temperature.
• Welch Allyn Connex Spot Vital Signs Monitor
This is the FDA approved reference device to measure heart rate, SpO2 and temperature.
• Capnostream 20 Portable Bedside Capnograph
This is the reference device to be used to obtain etCO2 waveforms for respiratory rate assessment.
• Welch Allyn 767 Mobile Aneroid Sphygmomanometerand 3M Littmann Master Classic II Teaching Stethoscope
These reference devices will be used together for blood pressure measurements.
• Scifit 1000R cycle ergometer
This is the device that will be used for exercise testing

Locations

Country	Name	City	State
United States	Partners Connected Health	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Vital USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Vital Moto Mod vital signs measurements in agreement with reference device vital signs measurements	Vital signs measurements for each participant would be compared using the Vital Moto Mod and reference devices for blood pressure, heart rate, respiratory rate, oxygen saturation and temperature	1 day