HemodynamicsNCT03867825
Hemodynamic Monitoring of Newborn Infants With Impedance Cardiography Versus Echocardiography; a Validation Study
An observational study of Hemodynamics, run by University Hospital of North Norway.
Trial summary
Background: Impedance cardiography (ICG) is a noninvasive method for continuous left cardiac output monitoring based on measurement of thoracic electrical bioimpedance. The objective of this study is to validate an ICG device by investigating the agreement in cardiac output (CO; left ventricular output x heart rate)… Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Hemodynamics
- What is being tested?
- Non-invasive hemodynamic monitoring
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Dec 2020
- 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 Up to 1 month
- All sexes
- Child
Study population: Term healthy infants
Who may be able to join
- Newborn infants
Who cannot join
- Infants > 1 month of age
About this study
Background:
Impedance cardiography (ICG) is a noninvasive method for continuous left cardiac output monitoring based on measurement of thoracic electrical bioimpedance. The objective of this study is to validate an ICG device by investigating the agreement in cardiac output (CO; left ventricular output x heart rate) measurements performed by ICG and echocardiography. The ICG device (PhysioFlow) has a new filter technology reducing signal noise and enabling measurements in patients who are moving freely.
Read more
Material and Methods
- Design: Prospective observational study.
- Inclusion: 30 healthy term infants between 24 and 48 hours of age, after parental consent
- Methods: Continuous measurement with ICG over a 30 min period and point of care echocardiography
- Primary outcome: Agreement (bis and precision) between measurement of CO with ICG and echocardiography.
- Secondary outcomes: Agreement between other echocardiographic indices of myocardial function and ICG parameters (early diastolic filling ratio, cardiac index, ventricular ejection time and left cardiac work index).
- Statistics: Agreement between ICG and echocardiography data will be evaluated using Bland-Altman statistics, including the calculation of mean bias (average difference between measurements) with corresponding standard deviation and lower and upper limits of agreements (95% confidence interval).
- Conditions
- Hemodynamics
- Being tested
- Non-invasive hemodynamic monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive hemodynamic monitoringDevice
Impedance cardiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output
Stroke volume x heart rate
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study startJan 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Never got medical equipment that worked properly
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodynamicsStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Knut Helge Kaspersen, MD, Per Ivar Kaaresen, MD, PhD, Nils Thomas Songstad, MD, PhD, Ganesh Acharya, Professor
- Responsible party
- Principal investigator, Claus Klingenberg, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867825
- Sponsor's protocol ID
- 2014/2312
- Status last verified
- Mar 2019
- First submitted
- 6 Mar 2019
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Monitoring of Newborn Infants With Impedance Cardiography Versus Echocardiography; a Validation Study
- ClinicalTrials.gov ID
- NCT03867825
- Acronym / sponsor ID
- 2014/2312
- Conditions
- Hemodynamics
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Never got medical equipment that worked properly
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Knut Helge Kaspersen, MD, Per Ivar Kaaresen, MD, PhD, Nils Thomas Songstad, MD, PhD, Ganesh Acharya, Professor
- Study start
- Jan 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 8 Mar 2019 (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.
Background:
Impedance cardiography (ICG) is a noninvasive method for continuous left cardiac output monitoring based on measurement of thoracic electrical bioimpedance. The objective of this study is to validate an ICG device by investigating the agreement in cardiac output (CO; left ventricular output x heart rate) measurements performed by ICG and echocardiography. The ICG device (PhysioFlow) has a new filter technology reducing signal noise and enabling measurements in patients who are moving freely.
Material and Methods
- Design: Prospective observational study.
- Inclusion: 30 healthy term infants between 24 and 48 hours of age, after parental consent
- Methods: Continuous measurement with ICG over a 30 min period and point of care echocardiography
- Primary outcome: Agreement (bis and precision) between measurement of CO with ICG and echocardiography.
- Secondary outcomes: Agreement between other echocardiographic indices of myocardial function and ICG parameters (early diastolic filling ratio, cardiac index, ventricular ejection time and left cardiac work index).
- Statistics: Agreement between ICG and echocardiography data will be evaluated using Bland-Altman statistics, including the calculation of mean bias (average difference between measurements) with corresponding standard deviation and lower and upper limits of agreements (95% confidence interval).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Age groups
- Child
- Study population
- Term healthy infants
Key inclusion criteria (1 listed)
- Newborn infants
Key exclusion criteria (1 listed)
- Infants > 1 month of age
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 hemodynamic monitoringImpedance cardiography | Device | – |
Primary outcome
Cardiac output
Time frame: one hour
Stroke volume x heart rate
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamics, run by University Hospital of North Norway.
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: withdrawn, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Cardiac output (time frame: one hour). 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 8 Mar 2019.