Validation of Near Infrared Spectroscopy (NIRS) During Heart-Lung Bypass in Children
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 4/2/2016 |
| Start Date: | April 2008 |
| End Date: | December 2008 |
| Contact: | Joseph Forbess, MD |
| Email: | joseph.forbess@utsouthwestern.edu |
| Phone: | 214-456-5000 |
Validation of Somatic and Cerebral Near Infrared Spectroscopy (NIRS) During Cardiopulmonary Bypass In Pediatric Patients: A Prospective Clinical Study
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.
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.
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.
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.
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).
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