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OpenTrials
Completed

NCT Number: NCT02641327

Monitoring Changes in Blood Pressure

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.

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Key information

Conditions

Blood Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wolfson Hospital

Holon, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

EarlySense (Passive monitoring)

Device

Passive contact-free monitoring

Primary outcomes

  1. Evaluate accuracy: Blood pressure measured by the EarlySense system in comparison with Gold Standard Devices

    Time frame: 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

Sponsors and collaborators

Lead sponsor

EarlySense Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 29, 2015
Registry last updated
Dec 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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