Monitoring Changes in Blood Pressure

NCT02641327 | Completed DMC

• 1 other identifier: ES-CLC-2015_Prot_1_BP
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Keywords

Inhospital patients

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Internal ward

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)

Device: EarlySense (Passive monitoring)

ICU

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

Device: EarlySense (Passive monitoring)

Interventions

EarlySense (Passive monitoring) DEVICE

Passive contact-free monitoring

ICU; Internal ward

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from 2 groups will be recruited: 1. 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) 2. Patients hospitalized in intensive care with arterial line that allow continuous blood pressure measurement

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• EarlySense Ltd.: lead

Study Sites (1)

Wolfson Hospital

Holon, Israel

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 29, 2015
• Study Start: December 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 1, 2016

Record last verified: 2016-09

Locations

IL (1)