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Hemodynamic Monitoring of Newborn Infants With Impedance Cardiography Versus Echocardiography; a Validation Study

NCT03867825 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2019-03-08

No results posted yet for this study

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) 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).

Conditions

  • Hemodynamics

Interventions

DEVICE

Non-invasive hemodynamic monitoring

Impedance cardiography

Sponsors & Collaborators

  • Knut Helge Kaspersen, MD

    collaborator UNKNOWN

  • Per Ivar Kaaresen, MD, PhD

    collaborator UNKNOWN

  • Nils Thomas Songstad, MD, PhD

    collaborator UNKNOWN

  • Ganesh Acharya, Professor

    collaborator UNKNOWN

  • University Hospital of North Norway

    lead OTHER

Eligibility

Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2020-12-31
Completion
2020-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03867825 on ClinicalTrials.gov