Comparing Cardiac Output Measurements in Critically Ill C... | NCT01460329

Studies
Comparing Cardiac Output Measurements in Critically Ill Children Using USCOM and Transthoracic ECHO

NCT01460329

Sponsor

University of North Carolina, Chapel Hill

Status

Completed

Last Update Posted

May 6, 2013Estimated

Enrollment

22Actual

Phase

Not provided

Conditions

Critical Illness
Pediatrics

Interventions

Ultrasonic Cardiac Output Monitor (USCOM).

Countries

United States

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

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Oct 24, 2011

First Submission Date that Met QC Criteria

Oct 24, 2011

First Posted Date

Oct 26, 2011Estimated

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

May 3, 2013

Last Update Posted Date

May 6, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nina Verdino, MD, Principal Investigator, University of North Carolina, Chapel HillPrincipal Investigator

Lead Sponsor

University of North Carolina, Chapel HillOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to compare the accuracy and precision of two non-invasive methods of measuring cardiac output in critically ill children (<18 yrs). The participants will include any patient admitted to Pediatric intensive care unit (PICU) requiring a trans-thoracic ECHO (TTE) as part of their treatment plan. Measurements of intermittent cardiac output will be obtained and compared on participants using standard 2-D TTE and Ultrasound Cardiac Output Monitor (USCOM).

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

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
USCOM Cardiac index			Device: Ultrasonic Cardiac Output Monitor (USCOM).

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasonic Cardiac Output Monitor (USCOM).	Device	This device is FDA approved and based on the principles of ECHO using continuous-wave Doppler ultrasound to measure cardiac output.

Measure	Description	Time Frame
Cardiac Index		measured at the time of study

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any UNC PICU patient <18 yrs requiring a transthoracic ECHO (TTE) as standard of care.
Gestational age >36 weeks
Wt > 2 kg
Written informed parental permission

Exclusion Criteria:

Any patient with known unrepaired intracardiac shunt lesion (ASD,PDA,VSD)
any post operative patient with delayed closure of chest
parental refusal to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

17 Years

Standard Ages

Child

Study Population

The subjects for this study can be either male or female and not limited by race or ethnicity. They will include critically ill pediatric patients, less than 18 yrs of age, being treated in the Pediatric intensive care unit.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nina J Verdino, MD	East Carolina University	Principal Investigator
Keith C Kocis, MD	University of North Carolina, Chapel Hill	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UNC Children's Hospital		Chapel Hill	North Carolina	27614	United States

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided