Evaluating the Accuracy of an Integrated Vital Sign Measurement Platform

Completed · Not applicable

Conditions studied: Multimorbidity

In brief

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.

Key facts

Study ID

NCT03589716

Run by

Massachusetts General Hospital

People needed

265

Starts

2018-07-23

Expected to finish

2019-12-30

Last updated by the study team

2020-09-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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
• 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).

Where it is running

• Partners Connected Health — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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