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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04220359
Other study ID # Biobeat005
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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