Evaluating the Accuracy of an Integrated Vital Sign Measurement Platform
1 other identifier
interventional
265
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2018
CompletedFirst Posted
Study publicly available on registry
July 18, 2018
CompletedStudy Start
First participant enrolled
July 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedSeptember 1, 2020
August 1, 2020
8 months
June 4, 2018
August 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Participants with Vital Signs Within Normal Range
OTHERAll participants will be asked to have an arm and finger measurement conducted and undergo vital sign measurements using the Vital Moto Mod and reference devices for blood pressure, heart rate, respiration rate, blood oxygen saturation, and temperature. Participants with vital signs within the normal physiological range will also be asked to perform an optional exercise testing and/or undergo arterial blood gas measurement.
Participants with Vital Signs Outside of Normal Range
OTHERAll participants will be asked to have an arm and finger measurement conducted and undergo vital sign measurements using the Vital Moto Mod and reference devices for blood pressure, heart rate, respiration rate, blood oxygen saturation, and temperature. Participants with vital signs outside of the normal physiological range would be documented.
Interventions
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.
This is the FDA approved reference device to measure heart rate, SpO2 and temperature.
This is the reference device to be used to obtain etCO2 waveforms for respiratory rate assessment.
These reference devices will be used together for blood pressure measurements.
This is the device that will be used for exercise testing
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Vital USA, Inc.collaborator
Study Sites (1)
Partners Connected Health
Boston, Massachusetts, 02114, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Kamal Jethwani
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dermatologist
Study Record Dates
First Submitted
June 4, 2018
First Posted
July 18, 2018
Study Start
July 23, 2018
Primary Completion
March 8, 2019
Study Completion
December 30, 2019
Last Updated
September 1, 2020
Record last verified: 2020-08