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Evaluating the Accuracy of an Integrated Vital Sign Measurement Platform

NCT03589716 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2020-09-01

No results posted yet for this study

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.

Conditions

  • Multimorbidity

Interventions

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

Sponsors & Collaborators

  • Vital USA, Inc.

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Kamal Jethwani · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-23
Primary Completion
2019-03-08
Completion
2019-12-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03589716 on ClinicalTrials.gov