Early Identification of Clinical Deterioration Using a Wearable Monitoring Device

Completed

• Conditions: Hemodynamic Instability; Clinical Deterioration

• Registration Number: NCT04220359
• Lead Sponsor: Biobeat Technologies Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-01
• Study First Submitted QC: 2020-01-04
• Study First Posted: 2020-01-07
• Study Start: 2020-07-06
• Primary Completion: 2021-04-15
• Study Completion: 2021-04-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-23
• Last Update Posted: 2021-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 410

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Sheba Medical Center, Tel Hashomer; 🇮🇱 Ramat Gan, Israel