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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04081987
Other study ID # BiPS
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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