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

NCT ID: NCT01460329

Last Updated: 2013-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-06-30

Brief Summary

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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

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Conditions

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Critical Illness Pediatrics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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USCOM Cardiac index

Ultrasonic Cardiac Output Monitor (USCOM).

Intervention Type DEVICE

This device is FDA approved and based on the principles of ECHO using continuous-wave Doppler ultrasound to measure cardiac output.

Interventions

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Ultrasonic Cardiac Output Monitor (USCOM).

This device is FDA approved and based on the principles of ECHO using continuous-wave Doppler ultrasound to measure cardiac output.

Intervention Type DEVICE

Other Intervention Names

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USCOM

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Nina Verdino, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nina J Verdino, MD

Role: PRINCIPAL_INVESTIGATOR

East Carolina University

Keith C Kocis, MD

Role: STUDY_CHAIR

University of North Carolina, Chapel Hill

Locations

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UNC Children's Hospital

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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11-1178

Identifier Type: -

Identifier Source: org_study_id

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