Validation of Near Infrared Spectroscopy (NIRS) During Heart-Lung Bypass in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 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:
NCT00745394
First received: August 29, 2008
Last updated: September 2, 2008
Last verified: September 2008
  Purpose

Non-invasive assessment of blood flow to organs has long challenged clinicians. Recently, near infrared spectroscopy (NIRS) has been recognized as a methodology that may achieve this goal. A commercially available NIRS monitor, marketed by Somanetics, Inc., is now in widespread use in the clinical care of pediatric cardiac patients in the operating room and in the intensive care unit post-operatively. When a patch/probe from the monitor is placed on the forehead or lower back, blood oxygen concentration data is obtained which has been found to correlate with actual blood samples taken by IV. The presence of this NIRS data would give the surgeon important feedback about blood flow to important areas like the brain and kidneys during heart surgeries on children and after the operation is completed in the intensive care unit.

The investigator wishes to perform a prospective study of the NIRS monitor use with children that need heart surgeries that require heart-lung bypass and sometimes require monitoring in the ICU, post-operatively.


Condition
Cardiopulmonary Bypass

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Somatic and Cerebral Near Infrared Spectroscopy (NIRS) During Cardiopulmonary Bypass In Pediatric Patients: A Prospective Clinical Study

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

Primary Outcome Measures:
  • Determine correlation between cerebral/somatic NIRS saturation data obtained on CPB and oxygen saturation and lactate data obtained from the superior vena caval (SVC) blood. [ Time Frame: Length of surgery with possible 5 day follow-up in the ICU ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: April 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Detailed Description:

After patients are prospectively consented pre-operatively, standard medical care, including the use of the NIRS monitor, will be implemented during the patient's operation and post-operatively in the intensive care unit with few modifications. These modifications include: (1) the placement of an oximetric probe in the lumen of the cardiopulmonary bypass circuit tubing which will output continuous blood oxygen content during bypass, (2) the addition of extra connectors to the bypass tubing to allow blood draws during surgery, (3) placement of doppler blood flow probes on the tubing to measure blood flow velocity, and (4) the addition of LFTs during the post-operative phase, if followed. Patients that receive operations that require circulatory arrest and/or selective cerebral perfusion will be followed in the ICU for 5 days. Data from the bypass machine along, data collected from the NIRS and oximetric probe monitor, and serum data will be interfaced into a data collection system.

Data to be collected: Minimum patient demographic data (age, sex, ethnic origin), NIRS data, serum blood gas data, serum lactate levels, hemoglobin levels, vital signs, doppler blood flow data, LFT analysis, clinical course events/data (i.e. need for dialysis, length of stay, surgical time points, etc), diagnostic test results (EKGs, ECHOs, etc), significant medical history data, and standard of care laboratory results.

The investigator wishes to evaluate the relationship of this data with the patient's diagnosis, operation performed, post-operative course, and outcome. Validation of the use of the NIRS monitor and further characterization of the NIRS monitor will also be sought.

  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 surgical correction of their congenital heart disease that require cardiopulmonary bypass.

Criteria

Inclusion Criteria:

  • 1. Patients that require cardiopulmonary bypass during surgical correction of heart disease
  • 2. Prospective, Informed Consent

Exclusion Criteria:

  • 1. Patients with malformations of venous return to the heart (e.g. interrupted IVC with azygous continuation).
  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: NCT00745394

Contacts
Contact: Joseph Forbess, MD 214-456-5000 joseph.forbess@utsouthwestern.edu

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

No publications provided

Responsible Party: Joseph Forbess, MD, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00745394     History of Changes
Other Study ID Numbers: 072007-057
Study First Received: August 29, 2008
Last Updated: September 2, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
NIRS
bypass
cardiopulmonary
CPB
monitoring
system

ClinicalTrials.gov processed this record on July 29, 2014