Evaluation and Calibration of a Novel Non-invasive Wearable Device for Monitoring Vital Signs

A Multi-center, Prospective, Pilot Study Intended for Data Collection to Evaluate and Calibrate a Novel Non-invasive Wearable Device for Monitoring Vital Signs

The purpose of this clinical study is to compare the measurement of vital signs (blood pressure, heart rate, respiration rate, blood oxygen levels and body temperature) measured by the non-invasive, continuous and wireless BiPS monitoring device with vital signs measured by current standard of care hospital equipment (blood pressure measurements will be obtained from arterial line) an invasive arterial line. The study will be conducted in two medical centers in Israel and include 50 adult patients that are connected to an arterial line as part of their routine care.

Study Overview

• Status: Unknown
• Conditions: Intensive Care Unit Patients; Post-cardiac Surgery
• Intervention / Treatment: Device: non-invasive monitoring

Detailed Description

BiPS Medical has developed a wearable, wireless device that conveniently monitors important vital sign trends over time - blood pressure (diastolic & systolic), heart and respiration rates, blood oxygen level (SPO2) and body temperature - to aid in identifying clinical deterioration. The device is base on a combination of inflatable mini finger cuff and photoplethysmograph technology.

The aim of this study is to collect data for evaluating and calibrating of the BiPS monitor for monitoring patient vital signs and compare it to current standard of care hospital monitors. The study population includes a total of 50 adult patients that are connected to an arterial line as part of their routine care. The BiPS non-invasive monitor will be attached to participating patients during their stay in the ICU/ recovery in cardiac ICU/Post Anesthesia Care Unit /other hospital designated unit. The device will be placed on the patient for 60 minutes while in hospital bed, in which up to 20 blood pressure measurements are performed (each takes up to 60 seconds). Heart and respiration rates, body temperature and SPO2 will be measured continuously while the device is attached to the patient hand.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Tomer Zaidenberg; Phone Number: +972-52-2793242; Email: tomer@bipsmedical.com

Study Locations

• Israel
  • Haifa, Israel, 3436212
    • Recruiting
    • Carmel Medical Center
    • Contact: Ariela Goldenberg, RN; Phone Number: +48250288; Email: ArielaGo1@clalit.org.il
  • Tel Aviv, Israel, 6423906
    • Not yet recruiting
    • Tel Aviv Sourasky Medical Center
    • Contact: Inbal Wolpin, CRA; Email: inbalw@tlvmc.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will include a total of 50 adult patients that are connected to an arterial line as part of their routine care (e.g., post operative cardiac patients, or intensive care unit patients), recruited in Sourasky Medical Center (Ichilov), Tel-Aviv and Carmel Medical Center, Haifa.

Description

Inclusion Criteria:

• Patients aged 18 years and older who agree to sign an informed consent.
• Patients connected to an arterial line as part of their routine care (e.g., patients recovering from cardiac or other major surgery)

Exclusion Criteria:

• Pregnant women.
• Patients under the age of 18.
• Patients who are not connected to an arterial line as part of their routine care.
• Unable to give informed consent.
• Patients with poor or no finger pulse.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of accordance between the BiPS monitor and the arterial line	Correlation between the vital sgns measured on The BiPS non-invasive monitor and those measured through the arterial line	60 minutes

Collaborators and Investigators

• Sponsor: BiPS Medical
• Collaborators: Tel-Aviv Sourasky Medical Center; Carmel Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 5, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Blood pressure; Vital signs; Arterial line; Non-invasive monitoring
• Other Study ID Numbers: BiPS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The researchers will probably share the experimental results showing the level of accordance between the two measurement methods, but not the information of each participant separately.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No