Comparison of Techniques for Assessing Cardiac Output and Preload in Critically Ill Pediatric Patients (GCH)

The ability to measure cardiac output (CO) accurately and reproducibly at frequent intervals remains elusive to the clinician caring for critically ill pediatric patients even though a large proportion of these children are known to have hemodynamic compromise as a result of their illness. Current techniques used in adults to measure CO are not suitable for routine use with pediatric patients. A new ultrasound dilution approach provides an opportunity to measure cardiac output and blood volumes in pediatric patients. The main aim of this study is to compare CO measured by the new method with the clinician's estimate and implied CO from the measurement of the arteriovenous oxygen content difference.

Study Overview

• Status: Completed
• Conditions: Cardiac Output

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Golisano Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients (up to 16 years of age ) in the ICU with in situ central venous and arterial catheters.

Description

Inclusion Criteria:

• Patients with in situ central venous and arterial catheters
• Ability to draw blood from arterial and central venous catheters
• Presence of parent or guardian to provide consent

Exclusion Criteria:

• Patients over 16 years of age.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Compare CO measured by the new method with clinician's estimate and implied CO from measurement of arteriovenous oxygen content difference.	5-8 minutes minimum

Secondary Outcome Measures

Outcome Measure	Time Frame
Measure blood volumes to compare effects of volume infusion and furosemide.	5-8 minutes minimum

Collaborators and Investigators

• Sponsor: Transonic Systems Inc.
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Karen Powers, MD, Golisano Children's Hospital

Publications and helpful links

General Publications

• Krivitski NM, Kislukhin VV, Thuramalla NV. Theory and in vitro validation of a new extracorporeal arteriovenous loop approach for hemodynamic assessment in pediatric and neonatal intensive care unit patients. Pediatr Crit Care Med. 2008 Jul;9(4):423-8. doi: 10.1097/01.PCC.0b013e31816c71bc.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: February 27, 2009
• First Submitted That Met QC Criteria: February 27, 2009
• First Posted (Estimate): March 2, 2009

Study Record Updates

• Last Update Posted (Estimate): May 27, 2016
• Last Update Submitted That Met QC Criteria: May 25, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Comparison of CO by new method to clinician's estimate and implied CO from the measurement of arteriovenous oxygen content difference.
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: TSI-G-COSTATUS-2A-H; 2R44HL061994-04A2 (U.S. NIH Grant/Contract)