Clinical DeteriorationNCT04220359
Early Identification of Clinical Deterioration Using a Wearable Monitoring Device
An observational study of Clinical Deterioration and Hemodynamic Instability, run by Biobeat Technologies Ltd. at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Clinical Deterioration, Hemodynamic Instability
- What is being tested?
- non-invasive monitoring
- Type of treatment
- Medical device
- How many people
- 410 participants
- Where
- 1 siteIsrael
- Study dates
- 6 Jul 2020to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- non-invasive monitoring
- Keywords
- vital signs, clinical deterioration, early prediction, non-invasive monitoring
- Medical subject headings
- Clinical Deterioration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive monitoringDevice
Also called BB-613PW
Prospective monitoring with retrospective big-data analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours per individual
Secondary outcomes (5)
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.
Measured: 72 hours per individual
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.
Measured: 72 hours per individual
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.
Measured: 72 hours per individual
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.
Measured: 72 hours per individual
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.
Measured: 72 hours per individual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start6 Jul 2020
- Primary completion15 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinical DeteriorationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biobeat Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sheba Medical Center
- Responsible party
- Sponsor
- Investigators
- Gad Segal, MD, Principal investigator, The Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220359
- Sponsor's protocol ID
- Biobeat005
- Status last verified
- May 2021
- First submitted
- 1 Jan 2020
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: The investigators plan to publish the data in a way that will allow all readers to access the data collected and analyzed
Publications
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.
PubMed 35679119
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04220359
- Acronym / sponsor ID
- Biobeat005
- Conditions
- Clinical Deterioration, Hemodynamic Instability
- Keywords
- vital signs, clinical deterioration, early prediction, non-invasive monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Biobeat Technologies Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sheba Medical Center
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 7 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive monitoringAlso: BB-613PWProspective monitoring with retrospective big-data analysis | Device | – |
Primary outcome
Monitoring blood pressure changes in high-risk patients
Time frame: 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.
5 secondary outcomes
Monitoring early heart rate changes in high-risk patients
Time frame: 72 hours per individual
Monitoring respiratory rate changes in high-risk patients
Time frame: 72 hours per individual
Monitoring blood oxygen saturation changes in high-risk patients
Time frame: 72 hours per individual
Monitoring stroke volume changes in high-risk patients
Time frame: 72 hours per individual
Monitoring cardiac output changes in high-risk patients
Time frame: 72 hours per individual
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Derived from this study: PubMed 35679119Itelman 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.
- Individual participant dataSharing planned: Undecided. The investigators plan to publish the data in a way that will allow all readers to access the data collected and analyzed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gad Segal, MD principal investigator
The Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Deterioration and Hemodynamic Instability, run by Biobeat Technologies Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitoring blood pressure changes in high-risk patients (time frame: 72 hours per individual). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04220359, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.