Monitoring Changes in Blood Pressure

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02641327
• Other study ID #: ES-CLC-2015_Prot_1_BP
• Status: Completed
• Phase: N/A
• First received: December 14, 2015
• Last updated: November 30, 2016
• Start date: December 2015
• Est. completion date: November 2016

Study information

• Verified date: September 2016
• Source: EarlySense Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• EarlySense (Passive monitoring)
Passive contact-free monitoring

Locations

Country	Name	City	State
Israel	Wolfson Hospital	Holon

Sponsors (1)

Lead Sponsor	Collaborator
EarlySense Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate accuracy: Blood pressure measured by the EarlySense system in comparison with Gold Standard Devices	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	3 months	No