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Accuracy of Non-invasive Non-oscillometric Blood Pressure Wristband

NCT03629535 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-02-02

Study results available
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Summary

The primary objective of the present investigation is to determine the accuracy of a non-invasive non-oscillometric blood pressure wristband device when compared to invasive intra-arterial blood pressure monitors. In an intensive care unit patients who already have an intra-arterial blood pressure monitor in place, this wristband device will be applied and blood pressure readings compared for approximately 15 minutes. Blood pressure readings will be gathered and compared.

Conditions

Interventions

DEVICE

Non-invasive non-oscillometric blood pressure wristband device

The device is a band intended to be worn on the wrist for intermittent blood pressure measurements. The device applies no inflatable mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet.

DEVICE

Invasive intra-arterial blood pressure monitors.

Because the subjects also have an intra-arterial blood pressure monitor in place, the subjects will serve as their own control

Sponsors & Collaborators

Principal Investigators

  • Greta Piper · NYU Langone Health

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2019-09-10
Completion
2019-09-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT03629535 on ClinicalTrials.gov