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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00745394
Recruitment Status : Unknown
Verified September 2008 by University of Texas Southwestern Medical Center.
Recruitment status was:  Recruiting
First Posted : September 3, 2008
Last Update Posted : September 3, 2008
Children's Medical Center Dallas
Information provided by:
University of Texas Southwestern Medical Center

Brief Summary:

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 or disease
Cardiopulmonary Bypass

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.

Study Type : Observational
Estimated Enrollment : 10 participants
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
Study Start Date : April 2008
Estimated Primary Completion Date : August 2008
Estimated Study Completion Date : December 2008

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00745394

Contact: Joseph Forbess, MD 214-456-5000

United States, Texas
Children's Medical Center Recruiting
Dallas, Texas, United States, 75235
Contact: Joseph Forbess, MD    214-456-5000   
Principal Investigator: Joseph Forbess, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Children's Medical Center Dallas
Principal Investigator: Joseph Forbess, MD University of Texas Southwestern Medical Center

Responsible Party: Joseph Forbess, MD, University of Texas Southwestern Medical Center Identifier: NCT00745394     History of Changes
Other Study ID Numbers: 072007-057
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: September 3, 2008
Last Verified: September 2008

Keywords provided by University of Texas Southwestern Medical Center: