Clinical trial NCT04220359: Early Identification of Clinical Deterioration Using a Wearable Monitoring Device
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clinical Deterioration
Hemodynamic Instability
Keywords: vital signs
clinical deterioration
early prediction
non-invasive monitoring
Lead sponsor: Biobeat Technologies Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Sheba Medical Center
First posted: 2020-01-07
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Monitoring blood pressure changes in high-risk patients
timeFrame: 72 hours per individual
Secondary outcomes:
measure: Monitoring early heart rate changes in high-risk patients
timeFrame: 72 hours per individual
measure: Monitoring respiratory rate changes in high-risk patients
timeFrame: 72 hours per individual
measure: Monitoring blood oxygen saturation changes in high-risk patients
timeFrame: 72 hours per individual
measure: Monitoring stroke volume changes in high-risk patients
timeFrame: 72 hours per individual
measure: Monitoring cardiac output changes in high-risk patients
timeFrame: 72 hours per individual
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: The Sheba Medical Center, Tel Hashomer
Study officials:
affiliation: The Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel
name: Gad Segal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.