Early Identification of Clinical Deterioration Using a Wearable Monitoring Device

Hemodynamic Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04220359
• Other study ID #: Biobeat005
• Status: Completed
• Start date: July 6, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: May 2021
• Source: Biobeat Technologies Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: April 30, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinical Deterioration
• Hemodynamic Instability

Intervention

Device:
• non-invasive monitoring
Prospective monitoring with retrospective big-data analysis

Locations

Country	Name	City	State
Israel	The Sheba Medical Center, Tel Hashomer	Ramat Gan

Sponsors (2)

Lead Sponsor	Collaborator
Biobeat Technologies Ltd.	Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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