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

March 6, 2019 updated by: Claus Klingenberg, University Hospital of North Norway

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 month (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Term healthy infants

Description

Inclusion Criteria:

  • Newborn infants

Exclusion Criteria:

  • Infants > 1 month of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac output
Time Frame: one hour
Stroke volume x heart rate
one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of North Norway

Collaborators

Knut Helge Kaspersen, MD
Per Ivar Kaaresen, MD, PhD
Nils Thomas Songstad, MD, PhD
Ganesh Acharya, Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

March 6, 2019

First Submitted That Met QC Criteria

March 6, 2019

First Posted (Actual)

March 8, 2019

Study Record Updates

Last Update Posted (Actual)

March 8, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2014/2312

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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