Critically IllNCT04215627
Comparing the PiCCO Monitor to the Non-invasive Biobeat (BB)-316PW in ICU Patients
An observational study of Critically Ill and Hemodynamic Instability, run by Biobeat Technologies Ltd. at 1 site in Israel.
Trial summary
The aim of this study is to compare hemodynamic monitoring using the invasive PiCCO device to the BB-613PW wireless, non-invasive PPG-based device, in critically ill patients within the ICU, suffering from hemodynamic instability and in need of vasopressor support. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Critically Ill, Hemodynamic Instability
- What is being tested?
- non-invasive monitoring
- Type of treatment
- Medical device
- How many people
- 9 participants
- Where
- 1 siteIsrael
- Study dates
- 26 Dec 2019to 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
- Adult, Older adult
Study population: Adult patients admitted to the ICU unit, suffering from shock and in need for vasopressor support of more than 0.2 mcg/Kg/Min for a period longer than 3 hours, and that the treating physician has decided there is a need to insert a PiCCO catheter for invasive monitoring of their hemodynamic condition. Total period of monitoring will be up to 72 hours.
Who may be able to join
- ICU adult patients in the need of vasopressor support of more than 0.2 mcg/Kg/Min for a period longer than 3 hours
- Patients in which PiCCO monitoring is needed
Who cannot join
- Refusal of the subject
- Technical difficulties in insertion of the PiCCO catheters
- Significant cardiac arrhythmias
- Significant valvular disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Invasive Hemodynamic Monitoring, Using the PiCCO Monitor, to a Non-invasive Photoplethysmography Based Device in Hemodynamic Unstable Critically Ill Patients, With Vasopressor Support
The aim of this study is to compare hemodynamic monitoring using the invasive PiCCO device to the BB-613PW wireless, non-invasive PPG-based device, in critically ill patients within the ICU, suffering from hemodynamic instability and in need of vasopressor support. Data will be gathered prospectively and analysed retrospectively.
- Conditions
- Critically Ill, Hemodynamic Instability
- Being tested
- non-invasive monitoring
- Keywords
- Critically Ill patients, blood pressure, vital signs, non-invasive monitoring, Vasopressor support
- Medical subject headings
- Critical Illness
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
Comparing the PiCCO monitor to the non-invasive BB-613PW device in hemodynamically unstable critically ill patients in the ICU
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of accordance between the BB-613PW to the PiCCO
We will compare the level of accordance of blood pressure, heart rate, stroke volume, cardiac output, heart rate variability, and systemic vascular resistance.
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 posted2 Jan 2020
- Study start26 Dec 2019
- 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.
- Other trials for Critically IllStudies 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
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biobeat Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Assaf-Harofeh Medical Center
- Responsible party
- Sponsor
- Investigators
- Ayana Dvir, MD, MHA, Principal investigator, The Assaf Harofeh Medical Center, Tzrifin, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215627
- Sponsor's protocol ID
- Biobeat004
- Status last verified
- Jul 2021
- First submitted
- 29 Dec 2019
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: We plan to share the anonymised data within a manuscript (both analysed data and the raw vital sign data).
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Invasive Hemodynamic Monitoring, Using the PiCCO Monitor, to a Non-invasive Photoplethysmography Based Device in Hemodynamic Unstable Critically Ill Patients, With Vasopressor Support
- ClinicalTrials.gov ID
- NCT04215627
- Acronym / sponsor ID
- Biobeat004
- Conditions
- Critically Ill, Hemodynamic Instability
- Keywords
- Critically Ill patients, blood pressure, vital signs, non-invasive monitoring, Vasopressor support
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Biobeat Technologies Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Assaf-Harofeh Medical Center
- Study start
- 26 Dec 2019 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 2 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.
The aim of this study is to compare hemodynamic monitoring using the invasive PiCCO device to the BB-613PW wireless, non-invasive PPG-based device, in critically ill patients within the ICU, suffering from hemodynamic instability and in need of vasopressor support. Data will be gathered prospectively and analysed retrospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the ICU unit, suffering from shock and in need for vasopressor support of more than 0.2 mcg/Kg/Min for a period longer than 3 hours, and that the treating physician has decided there is a need to insert a PiCCO catheter for invasive monitoring of their hemodynamic condition. Total period of monitoring will be up to 72 hours.
Key inclusion criteria (2 listed)
- ICU adult patients in the need of vasopressor support of more than 0.2 mcg/Kg/Min for a period longer than 3 hours
- Patients in which PiCCO monitoring is needed
Key exclusion criteria (5 listed)
- Refusal of the subject
- Technical difficulties in insertion of the PiCCO catheters
- Significant cardiac arrhythmias
- Significant valvular disease
- Pregnancy
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-613PWComparing the PiCCO monitor to the non-invasive BB-613PW device in hemodynamically unstable critically ill patients in the ICU | Device | – |
Primary outcome
Level of accordance between the BB-613PW to the PiCCO
Time frame: 72 hours per individual
We will compare the level of accordance of blood pressure, heart rate, stroke volume, cardiac output, heart rate variability, and systemic vascular resistance.
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 7 Jul 2021.
- Individual participant dataSharing planned: Undecided. We plan to share the anonymised data within a manuscript (both analysed data and the raw vital sign data).
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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.
Ayana Dvir, MD, MHA principal investigator
The Assaf Harofeh Medical Center, Tzrifin, 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 Critically Ill 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 2 inclusion and 5 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 7 Jul 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?
Level of accordance between the BB-613PW to the PiCCO (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?
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 7 Jul 2021.