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

Hemodynamics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03867825
• Other study ID #: 2014/2312
• Status: Withdrawn
• Start date: January 2020
• Est. completion date: December 2020

Study information

• Verified date: March 2019
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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) 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Gender: All
• Age group: N/A to 1 Month

Eligibility

Inclusion Criteria:

• Newborn infants

Exclusion Criteria:

• Infants > 1 month of age

Related Conditions & MeSH terms

• Hemodynamics

Intervention

Device:
• Non-invasive hemodynamic monitoring
Impedance cardiography

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital of North Norway	Ganesh Acharya, Professor, Knut Helge Kaspersen, MD, Nils Thomas Songstad, MD, PhD, Per Ivar Kaaresen, MD, PhD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output	Stroke volume x heart rate	one hour