Hemodynamic Monitoring of Newborn Infants With Impedance... | NCT03867825

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

NCT03867825

Sponsor

University Hospital of North Norway

Status

Withdrawn

Last Update Posted

Mar 8, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Hemodynamics

Interventions

Non-invasive hemodynamic monitoring

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Never got medical equipment that worked properly

Expanded Access Info

Start Date

Jan 2020Estimated

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Mar 6, 2019

First Submission Date that Met QC Criteria

Mar 6, 2019

First Posted Date

Mar 8, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2019

Last Update Posted Date

Mar 8, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claus Klingenberg, Professor, University Hospital of North NorwayPrincipal Investigator

Lead Sponsor

University Hospital of North NorwayOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-invasive hemodynamic monitoring	Device	Impedance cardiography

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Newborn infants

Exclusion Criteria:

Infants > 1 month of age

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

1 Month

Standard Ages

Child

Study Population

Term healthy infants

Sampling Method

Non-Probability Sample