Monitoring Changes in Blood Pressure

Protocol for Evaluation of EarlySense: A Contact-less Device for Monitoring Changes in Blood Pressure

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02641327

Enrollment

100

Registered

2015-12-29

Start date

2015-12-31

Completion date

2016-11-30

Last updated

2016-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Keywords

Inhospital patients

Brief summary

The study objective is to assess the accuracy of Earlysense contactless monitoring to detect changes in blood pressure vs. Gold reference method / devices including ambulatory blood pressure monitoring device (ABPM) or invasive blood pressure monitoring for patients who have arterial line as part of their standard clinical care.

Detailed description

The study objective is to collect data to assess the accuracy and reliability of Earlysense contactless monitoring for blood pressure monitoring vs. gold reference methods such as ABPM (Ambulatory blood pressure measurement) for patients hospitalized in Internal Medicine department and vs. Arterial Line measurements for patients hospitalized in ICU. In addition the collected data will be used to further enhance and improve the existing algorithms.

Interventions

DEVICEEarlySense (Passive monitoring)

Passive contact-free monitoring

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age 18 years and up 2. Patients hospitalized that require stabilization of his/ her blood Pressure 3. Is willing to sign the consent form. Group II: Patients hospitalized in Intensive Care 1. Age 18 years and up in intensive care with arterial line that allows invasive Blood Pressure measurements 2. Patient or next of kin or legal guardian are willing to sign consent form

Exclusion criteria

1. Age \< 18 years 2. Does not sleep on a mattress that allows placing EarlySense sensor under it 3. Patient or next of kin or legal guardian is not willing to sign consent form

Design outcomes

Primary

Measure	Time frame	Description
Evaluate accuracy: Blood pressure measured by the EarlySense system in comparison with Gold Standard Devices	3 months	Determine the accuracy of the EarlySense system to measure blood pressure in a contactless way: we would like to see what were the BP measurements in the Gold Standard Devices, compares to what the EarlySense System was measuring at the same time

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026