Early Identification of Clinical Deterioration Using a Wearable Monitoring Device

Sponsor
Biobeat Technologies Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04220359
Collaborator
Sheba Medical Center (Other)
410
1
9.8
41.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: non-invasive monitoring

Study Design

Study Type:
Observational
Actual Enrollment :
410 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Jul 6, 2020
Actual Primary Completion Date :
Apr 15, 2021
Actual Study Completion Date :
Apr 30, 2021

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Sheba Medical Center, Tel Hashomer Ramat Gan Israel 52621

Sponsors and Collaborators

  • Biobeat Technologies Ltd.
  • Sheba Medical Center

Investigators

  • Principal Investigator: Gad Segal, MD, The Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Biobeat Technologies Ltd.
ClinicalTrials.gov Identifier:
NCT04220359
Other Study ID Numbers:
  • Biobeat005
First Posted:
Jan 7, 2020
Last Update Posted:
May 25, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Keywords provided by Biobeat Technologies Ltd.
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2021