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

Post-cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04081987
• Other study ID #: BiPS
• Status: Recruiting
• Start date: November 20, 2019
• Est. completion date: March 2020

Study information

• Verified date: January 2020
• Source: BiPS Medical
• Contact: Tomer Zaidenberg
• Phone: +972-52-2793242
• Email: tomer[@]bipsmedical.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intensive Care Unit Patients
• Post-cardiac Surgery

Intervention

Device:
• non-invasive monitoring
Comparing blood pressure (diastolic & systolic), heart and respiration rates, blood oxygen level and body temperature measurement using the BiPS non-invasive monitor to an arterial line.

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (3)

Lead Sponsor	Collaborator
BiPS Medical	Carmel Medical Center, Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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