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

• Conditions: Post-cardiac Surgery; Intensive Care Unit Patients

• Registration Number: NCT04081987
• Lead Sponsor: BiPS Medical

Brief 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.

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 Timeline

• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-05
• Study First Posted: 2019-09-09
• Study Start: 2019-11-20
• Status Verified: 2020-01
• Primary Completion: 2020-01
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-14
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (2)

Carmel Medical Center; 🇮🇱 Haifa, Israel

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel