Monitoring Changes in Blood Pressure

EarlySense

Status: Completed

Conditions: Blood Pressure

Treatments: Device: EarlySense (Passive monitoring)

Study type: Observational

Funder types: Industry

Identifiers

NCT02641327

ES-CLC-2015_Prot_1_BP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

100 participants in 2 patient groups

Internal ward

Description:

Patients hospitalized in Internal Medicine unit with unstable blood pressure that need regulation/ stabilization of their blood pressure (e.g., CHF, post surgical, hypotension or Hypertension patients, patients with kidney failure, heart disease, stroke)

Treatment:

Device: EarlySense (Passive monitoring)

ICU

Description:

Patients hospitalized in intensive care with arterial line that allow continuous blood pressure measurement

Treatment:

Device: EarlySense (Passive monitoring)