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
1 other identifier
observational
50
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2019
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2019
CompletedFirst Posted
Study publicly available on registry
September 9, 2019
CompletedStudy Start
First participant enrolled
November 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedJanuary 14, 2020
January 1, 2020
1 month
September 4, 2019
January 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BiPS Medicallead
- Tel-Aviv Sourasky Medical Centercollaborator
- Carmel Medical Centercollaborator
Study Sites (2)
Carmel Medical Center
Haifa, 3436212, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2019
First Posted
September 9, 2019
Study Start
November 20, 2019
Primary Completion
January 1, 2020
Study Completion
March 1, 2020
Last Updated
January 14, 2020
Record last verified: 2020-01