Trial record 8 of 56 for:    echocardiography | Open Studies | NIH, U.S. Fed

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
  Purpose

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.


Condition
Cardiac Output

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation of a Novel, Minimally Invasive Ultrasound Indicator Dilution Technique for Measuring Cardiac Index in Critically Ill Children

Resource links provided by NLM:


Further study details as provided by Transonic Systems Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: June 2008
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852254

Contacts
Contact: Satish Rajagopal, MD 617-355-7866 Satish.Rajagopal@CARDIO.CHBOSTON.ORG

Locations
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Satish Rajagopal, MD    617-355-7866    Satish.Rajagopal@CARDIO.CHBOSTON.ORG   
Principal Investigator: Satish Rajagopal, MD         
Sponsors and Collaborators
Transonic Systems Inc.
Investigators
Principal Investigator: Satish Rajagopal, MD Children's Hospital Boston
  More Information

Publications:
Responsible Party: Nikolai Krivitski/Principal Investigator, Transonic Systems Inc.
ClinicalTrials.gov Identifier: NCT00852254     History of Changes
Other Study ID Numbers: TSI-C-COSTATUS-6A-H, 2R44HL061994-04A2
Study First Received: February 25, 2009
Last Updated: April 9, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Transonic Systems Inc.:
Cardiac Index
Ultrasound Diltion
Accuracy of ultrasound dilution cardiac index.

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014