Validation of Minimally Invasive Ultrasound Indicator Dilution Technique in Critically Ill Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Transonic Systems Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Transonic Systems Inc.
ClinicalTrials.gov Identifier:
NCT00852254
First received: February 25, 2009
Last updated: April 9, 2010
Last verified: April 2010

February 25, 2009
April 9, 2010
June 2008
May 2011   (final data collection date for primary outcome measure)
To determine the accuracy of cardiac index measured by ultrasound dilution when compared to the gold-standard Fick technique. [ Time Frame: 5-8 minutes minimum ] [ Designated as safety issue: No ]
To determine the accuracy of cardiac index measured by ultrasound dilution when compared to the gold-standard Fick technique. [ Time Frame: 1-3 years (2008-2011) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00852254 on ClinicalTrials.gov Archive Site
To determine the precision and feasibility of the measurements. Also to determine whether central blood volume (CBV) measured by ultrasound dilution correlates with central venous pressure (CVP) and echocardiography derived preload measures. [ Time Frame: 5-8 minutes minimum ] [ Designated as safety issue: No ]
To determine the precision and feasibility of the measurements. Also to determine whether central blood volume (CBV) measured by ultrasound dilution correlates with central venous pressure (CVP) and echocardiography derived preload measures. [ Time Frame: 1-3 years (2008-2011) ] [ Designated as safety issue: No ]
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Validation of Minimally Invasive Ultrasound Indicator Dilution Technique in Critically Ill Children
Validation of a Novel, Minimally Invasive Ultrasound Indicator Dilution Technique for Measuring Cardiac Index in Critically Ill Children

A novel method to measure cardiac index based on ultrasound indicator dilution technology (UIDT) has been developed by Transonic Systems Inc. (Ithaca, NY, USA). The method overcomes many of the limitations that have plagued the existing techniques used to measure cardiac index in critically ill children.

In the proposed investigation, the investigators hope to validate a novel application of an existing technology in critically ill infants and children. The primary aim of this study is to determine the accuracy of cardiac index measured by UIDT when compared to the gold-standard Fick technique. The primary hypothesis is that the average of three consecutive measurements of cardiac index by UIDT will be accurate when compared to the Fick technique. Secondary aims will be to determine the precision of the measurement, the feasibility of the technique with regards to time required and any complications encountered. An exploratory secondary aim of this study is to determine whether central blood volume (CBV) derived from indicator transit time (ITT) correlates with central venous pressure (CVP) and echocardiography derived measures of preload.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Pediatric patients (less than 18 years of age) with in situ arterial and central venous catheters.

Cardiac Output
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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 May 19; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
May 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age: less than 18 years.
  • Admission to the CICU (8S) or MISICU (7S) of the Children's Hospital Boston.
  • Presence of a central venous catheter with its tip in the superior vena cava or a catheter in the pulmonary artery, documented by radiography.
  • Requirement for mechanical ventilation via an endotracheal or tracheostomy tube.
  • Presence of an arterial catheter.
  • Patients must have a two ventricle circulation.

Exclusion Criteria:

  • Endotracheal tube leak of greater than 10%.
  • A significant air leak around the endotracheal tube makes VO2 impossible to measure.
  • Presence of relevant intracardiac shunt.
  • Intracardiac shunt will decrease the area under the arterial dilution curve unpredictably, making cardiac index calculations unreliable.
  • A patent foramen ovale and a single ventricular septal defect less than or equal to 2mm or an atrial septal defect less than or equal to 3mm will be considered irrelevant for the purposes of this study.
  • Previous enrollment in an incompatible research study.
  • Current or prior diagnosis of heparin induced thrombocytopenia.
  • A small amount of heparin is required to flush the extracorporeal AV loop that is required for the measurements.
  • Pneumothorax with ongoing air leak.
  • An air leak will invalidate the measurement of VO2.
Both
up to 18 Years
No
Contact: Satish Rajagopal, MD 617-355-7866 Satish.Rajagopal@CARDIO.CHBOSTON.ORG
United States
 
NCT00852254
TSI-C-COSTATUS-6A-H, 2R44HL061994-04A2
No
Nikolai Krivitski/Principal Investigator, Transonic Systems Inc.
Transonic Systems Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Satish Rajagopal, MD Children's Hospital Boston
Transonic Systems Inc.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP