Early Identification of Clinical Deterioration Using a Wearable Monitoring Device

NCT04220359 | Completed FDA Device

• 1 other identifier: Biobeat005
• Study Type: observational
• Target: 410
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Deterioration; Hemodynamic Instability

Keywords

vital signs; clinical deterioration; early prediction; non-invasive monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Monitoring early heart rate changes in high-risk patients

  72 hours per individual

• Monitoring respiratory rate changes in high-risk patients

  72 hours per individual

• Monitoring blood oxygen saturation changes in high-risk patients

  72 hours per individual

• Monitoring stroke volume changes in high-risk patients

  72 hours per individual

• Monitoring cardiac output changes in high-risk patients

  72 hours per individual

Interventions

non-invasive monitoring DEVICE

Prospective monitoring with retrospective big-data analysis

Also known as: BB-613PW

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biobeat Technologies Ltd.: lead
• Sheba Medical Center: collaborator

Study Sites (1)

The Sheba Medical Center, Tel Hashomer

Ramat Gan, 52621, Israel

Location

Related Publications (1)

• 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.

  PMID: 35679119 DERIVED

MeSH Terms

Conditions

Clinical Deterioration

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gad Segal, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2020
• First Posted: January 7, 2020
• Study Start: July 6, 2020
• Primary Completion: April 15, 2021
• Study Completion: April 30, 2021
• Last Updated: May 25, 2021

Record last verified: 2021-05

Locations

IL (1)