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

NCT03867825 | Withdrawn

• 1 other identifier: 2014/2312
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Cardiac output

  Stroke volume x heart rate

  one hour

Interventions

Non-invasive hemodynamic monitoring DEVICE

Impedance cardiography

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Term healthy infants

You may qualify if:

• Newborn infants

You may not qualify if:

• Infants \> 1 month of age

Sponsors & Collaborators

• University Hospital of North Norway: lead
• Knut Helge Kaspersen, MD: collaborator
• Per Ivar Kaaresen, MD, PhD: collaborator
• Nils Thomas Songstad, MD, PhD: collaborator
• Ganesh Acharya, Professor: collaborator

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 8, 2019
• Study Start: January 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 8, 2019

Record last verified: 2019-03