NCT03589716

Evaluating the Accuracy of an Integrated Vital Sign Measurement Platform

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Multimorbidity

Interventions

Type	Name	Description
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.
OTHER	Welch Allyn Connex Spot Vital Signs Monitor	This is the FDA approved reference device to measure heart rate, SpO2 and temperature.
OTHER	Capnostream 20 Portable Bedside Capnograph	This is the reference device to be used to obtain etCO2 waveforms for respiratory rate assessment.
OTHER	Welch Allyn 767 Mobile Aneroid Sphygmomanometerand 3M Littmann Master Classic II Teaching Stethoscope	These reference devices will be used together for blood pressure measurements.
OTHER	Scifit 1000R cycle ergometer	This is the device that will be used for exercise testing

Timeline

• Start date: 2018-07-23
• Primary completion: 2019-03-08
• Completion: 2019-12-30
• First posted: 2018-07-18
• Last updated: 2020-09-01

Locations

1 site across 1 country: United States