Early Identification of Clinical Deterioration Using a Wearable Monitoring Device

Early Identification of Hospitalized Patients at High-risk for Clinical Deterioration During the First 72-hours in an Internal Medicine Department. A Prospective, Continuous, Physiologic Big-data-analysis Study

This study aims to provide myriad of physiological parameters in patients admitted in an internal medicine department, and which are defined as being in an increased risk of clinical deterioration within the first 72-hours after admission. The investigators will also conduct a retrospective comparison between physiological changes in patients who did deteriorate to those who did not. This will form the basis for the development of an algorithm for early prediction and warning of physiological and clinical deterioration during the first 72-hours of admission.

Study Overview

• Status: Completed
• Conditions: Hemodynamic Instability; Clinical Deterioration
• Intervention / Treatment: Device: non-invasive monitoring

• Study Type: Observational
• Enrollment (Actual): 410

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel, 52621
    • The Sheba Medical Center, Tel Hashomer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and female patients 18 years and older admitted to the internal medicine department and are at high-risk for clinical deterioration during the first 72-hours after admission. The investigators anticipate it will include patients with acute and chronic cardio-respiratory disease, systemic infections, etc.

Description

Inclusion Criteria:

• Males and females 18 years old and above admitted to the internal medicine department
• On admission, the primary investigator assess their risk to deteriorate during the first 72 hours after admission as reasonably high
• The patient is assigned to a "monitoring bed" within the department
• The patient has signed an informed consent form

Exclusion Criteria:

• Lack of informed consent
• It is known in advance that the patient cannot take part in the study for a 72-hours period (e.g. a patient that will be taken to surgery within the next 24 hours)
• Technical inability to attach the Biobeat patch (BB-613PW) to the patients chest

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monitoring blood pressure changes in high-risk patients	The investigators will record blood pressure measurements using a non-invasive wireless monitoring device working continuously for 72 hours in high-risk patients.	72 hours per individual

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monitoring early heart rate changes in high-risk patients	The investigators will record heart rate using a non-invasive wireless monitoring device working continuously for 72 hours in high-risk patients.	72 hours per individual
Monitoring respiratory rate changes in high-risk patients	The investigators will record respiratory rate using a non-invasive wireless monitoring device working continuously for 72 hours in high-risk patients.	72 hours per individual
Monitoring blood oxygen saturation changes in high-risk patients	The investigators will record blood oxygen saturation using a non-invasive wireless monitoring device working continuously for 72 hours in high-risk patients.	72 hours per individual
Monitoring stroke volume changes in high-risk patients	The investigators will record stroke volume measurements using a non-invasive wireless monitoring device working continuously for 72 hours in high-risk patients.	72 hours per individual
Monitoring cardiac output changes in high-risk patients	The investigators will record cardiac output measurements using a non-invasive wireless monitoring device working continuously for 72 hours in high-risk patients.	72 hours per individual

Collaborators and Investigators

• Sponsor: Biobeat Technologies Ltd.
• Collaborators: Sheba Medical Center
• Investigators: Principal Investigator: Gad Segal, MD, The Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel

Publications and helpful links

General Publications

• Itelman E, Shlomai G, Leibowitz A, Weinstein S, Yakir M, Tamir I, Sagiv M, Muhsen A, Perelman M, Kant D, Zilber E, Segal G. Assessing the Usability of a Novel Wearable Remote Patient Monitoring Device for the Early Detection of In-Hospital Patient Deterioration: Observational Study. JMIR Form Res. 2022 Jun 9;6(6):e36066. doi: 10.2196/36066.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 6, 2020
• Primary Completion (ACTUAL): April 15, 2021
• Study Completion (ACTUAL): April 30, 2021

Study Registration Dates

• First Submitted: January 1, 2020
• First Submitted That Met QC Criteria: January 4, 2020
• First Posted (ACTUAL): January 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 23, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: vital signs; non-invasive monitoring; clinical deterioration; early prediction
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression; Clinical Deterioration
• Other Study ID Numbers: Biobeat005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The investigators plan to publish the data in a way that will allow all readers to access the data collected and analyzed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No