Validation of Venous Cannulae Flow Ratings

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Children's Medical Center Dallas
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00906906
First received: May 19, 2009
Last updated: May 20, 2009
Last verified: May 2009
  Purpose

The purpose of this study is to characterize blood flow in the plastic tubing of a heart-lung bypass machine during heart surgery. Technical specifications provided by the manufacturer do not consider varying hemodynamic conditions such as temperature and hemoglobin levels which affect blood viscosity and ultimately blood flow to and from the patient during heart-lung bypass.

The investigator wishes to perform a prospective study of the heart-lung bypass tubing in children that require heart-lung bypass during heart surgery.


Condition Intervention
Cardiopulmonary Bypass
Device: Doppler probes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Venous Cannulae Flow Ratings of the DLP Right Angle Cannulaes Utilizing Ultrasound Transit Time Technology

Further study details as provided by University of Texas Southwestern Medical Center:

Estimated Enrollment: 50
Study Start Date: January 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patient to receive CPB
Device: Doppler probes
Probes to be placed on CPB tubing to measure blood flow

Detailed Description:

During bypass, venous drainage is essential for maintaining proper perfusion of a pediatric patient. The quality of venous drainage has a large impact on the level of care the patient is provided. This study will investigate blood flow velocities through right angle venous cannulae which are utilized during bypass. The flows from each cannulae will be analyzed by using doppler flow probes which employ Transit Time Technology. This type of technology has crystals within the flow probes which send magnetic signals through the tubing with the purpose to determine the most accurate flows of blood. There is little evidence that identifies the actual amount of blood flow generated from each venous cannulae in a clinical setting. Manufacturers of venous cannulae for CPB publish flow ratings for the different sized cannulae available. These flow ratings are gathered from data produced in a non-clinical lab and are often very inaccurate. Because of this inaccuracy, selection is based on experience rather than published clinical data. This study would be instrumental in determining any and all potential risks or benefits to the patient as a result of the amount of drainage provided by the venous cannulae during bypass. A sample size of 50 patients (n=50) over one day old will be utilized for this study. The specific venous cannulae sizes that will be analyzed are the 12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 24Fr, & 28Fr DLP (DLP and Fr are the type and size of cannulae, respectively) right angle cannulae. The doppler flow probes that will be utilized during this study are reusable, non-invasive, clamp-on devices which measure blood flow through the CPB tubing. Each patient will have one flow probe placed on each venous cannulae prior to starting CPB. Bypass itself will not be altered in anyway. Hemoglobin blood levels, blood temperature, and pressure from the venous line will be recorded throughout CPB and are digitally sampled via the CPB machine (e.g. no blood draw required). To further examine the quality of venous drainage, a pressure transducer will be attached to the venous line measuring the amount of negative pressure being generated by the venous cannulae. The negative pressure line will be attached to the venous line at a stopcock that is already present in our CPB circuit. Each cannulae size will be analyzed three times to acquire the proper amount of data needed to fulfill the statistical and practical needs for the study. A descriptive analysis of the continuous and categorical data will be performed using means, standard deviations, confidence intervals, proportions, and frequency distributions. Statistical testing will include parametric and non-parametric bi-variate and multi-variate techniques as appropriate to the variables' level of measurement and distributions.

  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

Children who undergo heart-lung bypass during surgical correction of their congenital or acquired heart disease.

Criteria

Inclusion Criteria:

  • All Patients that require cardiopulmonary bypass during cardiac surgery.

Exclusion Criteria:

  • The only exclusion criteria would be if CPB is not required for surgical repair.
  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: NCT00906906

Contacts
Contact: Richard Ginther, CCP 214-456-5000 richard.ginther@utsouthwestern.edu
Contact: Joseph Forbess, MD 214-456-5000 joseph.forbess@utsouthwestern.edu

Locations
United States, Texas
Children's Medical Center Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Richard Ginther, CCP    214-456-5000    richard.ginther@utsouthwestern.edu   
Contact: Joseph Forbess, MD    214-456-5000    joseph.forbess@utsouthwestern.edu   
Principal Investigator: Richard Ginther, CCP         
Sub-Investigator: Joseph Forbess, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Children's Medical Center Dallas
Investigators
Principal Investigator: Richard Ginther, CCP University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Joseph Forbess, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00906906     History of Changes
Other Study ID Numbers: 122007-025
Study First Received: May 19, 2009
Last Updated: May 20, 2009
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 28, 2014