Underdamping/Resonance ArtifactsNCT05166993
Dynamic Electronic Filter for Arterial Waveform Distortion
An observational study of Underdamping/Resonance Artifacts, run by University of Florence at 1 site in Italy.
Trial summary
Invasive blood pressure (IBP) is the gold standard for arterial pressure (AP) monitoring in critically ill patients. Nevertheless, IBP may be affected by underdamping/resonance artifacts, that eventually lead to AP overestimation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Underdamping/Resonance Artifacts
- What is being tested?
- MostCareUp
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2017to 15 Sep 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to postoperative intensive care unit.
Who may be able to join
- ICU patients with invasive blood pressure (radial artery) affected by underdamping/resonance artifacts;
Who cannot join
- Arrhythmias
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arterial Pressure Waveform Distortion: a New Dynamic Electronic Filter for Automatic Correction of Underdamping/Resonance Artifact. A Prospective Study
Invasive blood pressure (IBP) is the gold standard for arterial pressure (AP) monitoring in critically ill patients. Nevertheless, IBP may be affected by underdamping/resonance artifacts, that eventually lead to AP overestimation. In these cases, when a pulse contour method is applied, wrong hemodynamic data are also delivered by the monitor. In order to overtake this issue, MostCareUp (a PCM powered by Pressure Recording Analytical Method, PRAM), has been implemented with a dynamic electronic filter (EFMC) that automatically corrects the resonant AP waveform.
In order to test the EFMC, the electronically corrected AP and the derived cardiac output were compared with respective raw data corrected with the Accudynamic, an adjustable damping device specifically manufactured for normalizing the pressure waveform (in our study: the reference method).
- Conditions
- Underdamping/Resonance Artifacts
- Being tested
- MostCareUp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MostCareUpDevice
Pressure transducers have been connected to the MostCareUp and the hemodynamic parameters compared as follows: no filter, electronic filter, no electronic filter plus Accudynamic (our reference system). Invasive pressure values have been then compared with the non-invasive ones.
What is being measured
The primary outcome is the main question the study is designed to answer.
The present study was aimed to test the MostCareUp electronic filter
To test the electronic filter comparing the electronically corrected arterial pressure and the derived cardiac output values with those corrected with the Accudynamic, a mechanical adjustable damping device commonly used in clinical practice.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start15 Mar 2017
- Primary completion15 Sep 2018
- Study completion15 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Underdamping/Resonance ArtifactsStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Villa, University of Florence
- Investigators
- Stefano Romagnoli, Prof, Study director, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166993
- Sponsor's protocol ID
- 10285
- Status last verified
- Dec 2021
- First submitted
- 20 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Pressure Waveform Distortion: a New Dynamic Electronic Filter for Automatic Correction of Underdamping/Resonance Artifact. A Prospective Study
- ClinicalTrials.gov ID
- NCT05166993
- Acronym / sponsor ID
- 10285
- Conditions
- Underdamping/Resonance Artifacts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 15 Sep 2018 (actual)
- First posted
- 22 Dec 2021 (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.
Invasive blood pressure (IBP) is the gold standard for arterial pressure (AP) monitoring in critically ill patients. Nevertheless, IBP may be affected by underdamping/resonance artifacts, that eventually lead to AP overestimation. In these cases, when a pulse contour method is applied, wrong hemodynamic data are also delivered by the monitor. In order to overtake this issue, MostCareUp (a PCM powered by Pressure Recording Analytical Method, PRAM), has been implemented with a dynamic electronic filter (EFMC) that automatically corrects the resonant AP waveform.
In order to test the EFMC, the electronically corrected AP and the derived cardiac output were compared with respective raw data corrected with the Accudynamic, an adjustable damping device specifically manufactured for normalizing the pressure waveform (in our study: the reference method).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to postoperative intensive care unit.
Key inclusion criteria (1 listed)
- ICU patients with invasive blood pressure (radial artery) affected by underdamping/resonance artifacts;
Key exclusion criteria (1 listed)
- Arrhythmias
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 |
|---|---|---|
| MostCareUpPressure transducers have been connected to the MostCareUp and the hemodynamic parameters compared as follows: no filter, electronic filter, no electronic filter plus Accudynamic (our reference system). Invasive pressure values have been then compared with the non-invasive ones. | Device | – |
Primary outcome
The present study was aimed to test the MostCareUp electronic filter
Time frame: 15 minutes
To test the electronic filter comparing the electronically corrected arterial pressure and the derived cardiac output values with those corrected with the Accudynamic, a mechanical adjustable damping device commonly used in clinical practice.
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 12 Jan 2022.
- Individual participant dataSharing planned: Undecided
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.
Stefano Romagnoli, Prof study director
University of Florence
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 Underdamping/Resonance Artifacts, run by University of Florence at 1 site in Italy.
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 1 inclusion and 1 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 12 Jan 2022. 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 Italy. 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?
The present study was aimed to test the MostCareUp electronic filter (time frame: 15 minutes). 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 12 Jan 2022.