Validation of Brain Oxygenation Monitor on Pediatric Patients
| Status: | Terminated |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 4/21/2016 |
| Start Date: | February 2009 |
| End Date: | November 2014 |
Validation of the CAS Medical System, Inc. FORE-SIGHT Near-Infrared Spectroscopy (NIRS) Monitor in Pediatric Subjects for Viscerosomatic Applications
The aim of this study is calibrate (adjust and tune) the CAS FORE-SIGHT Near-Infrared
Spectroscopy (NIRS) monitor when used to measure the tissue oxygen saturation of internal
organs (StO2). This is a measure of the amount of oxygen carried by the blood within the
internal organs. In addition the study will assess the degree of similarities between StO2
and mean mixed venous oxygen saturation - a measure of the amount of oxygen carried in the
blood returning to the heart.
Spectroscopy (NIRS) monitor when used to measure the tissue oxygen saturation of internal
organs (StO2). This is a measure of the amount of oxygen carried by the blood within the
internal organs. In addition the study will assess the degree of similarities between StO2
and mean mixed venous oxygen saturation - a measure of the amount of oxygen carried in the
blood returning to the heart.
NIRS cerebral oximeters are FDA-approved devices used to measure oxygen saturation within
the brain, in a similar manner to pulse oximeters that measure the oxygen saturation in the
finger tip. The sensor pads are placed on the surface of the forehead and shine
near-infrared light through the skull and brain tissue from which the brain tissue oxygen
saturation is estimated. The same principles can be applied when the sensor pads are placed
over the internal organs of the abdomen, for example, the liver. Currently the only way to
accurately measure the oxygen saturation of internal organs is by the invasive placement of
intravenous lines into the blood vessels of that organ. This study will determine if the
NIRS sensors can reliably estimate the tissue oxygen saturation non-invasively by placing
the pad over the skin of the abdomen.
The study will be conducted in pediatric patients who are undergoing cardiac
catheterization, a procedure in which invasive lines are placed in order to get information
about the heart. The procedure is always conducted under general anesthesia. During the
cardiac catheterization procedure blood samples are routinely taken for oxygen saturation
analysis. In the study two oximeter sensor pads will be placed on the forehead (one on each
side) and two further oximeter sensor pads will be placed on the abdominal wall. The oxygen
saturation values from all oximeter sensors will be recorded continuously throughout the
cardiac catheterization procedure and will be compared to the oxygen saturation values from
the blood samples. In addition to the routine blood samples taken as part of the cardiac
catheterization, one blood sample will be taken when the invasive line is within the right
hepatic (liver) vein.
The information from this study will determine how well the oximeter sensors estimate the
oxygen saturation of both the internal organs (StO2) and the blood returning to the heart
(mean mixed venous oxygen saturation).
the brain, in a similar manner to pulse oximeters that measure the oxygen saturation in the
finger tip. The sensor pads are placed on the surface of the forehead and shine
near-infrared light through the skull and brain tissue from which the brain tissue oxygen
saturation is estimated. The same principles can be applied when the sensor pads are placed
over the internal organs of the abdomen, for example, the liver. Currently the only way to
accurately measure the oxygen saturation of internal organs is by the invasive placement of
intravenous lines into the blood vessels of that organ. This study will determine if the
NIRS sensors can reliably estimate the tissue oxygen saturation non-invasively by placing
the pad over the skin of the abdomen.
The study will be conducted in pediatric patients who are undergoing cardiac
catheterization, a procedure in which invasive lines are placed in order to get information
about the heart. The procedure is always conducted under general anesthesia. During the
cardiac catheterization procedure blood samples are routinely taken for oxygen saturation
analysis. In the study two oximeter sensor pads will be placed on the forehead (one on each
side) and two further oximeter sensor pads will be placed on the abdominal wall. The oxygen
saturation values from all oximeter sensors will be recorded continuously throughout the
cardiac catheterization procedure and will be compared to the oxygen saturation values from
the blood samples. In addition to the routine blood samples taken as part of the cardiac
catheterization, one blood sample will be taken when the invasive line is within the right
hepatic (liver) vein.
The information from this study will determine how well the oximeter sensors estimate the
oxygen saturation of both the internal organs (StO2) and the blood returning to the heart
(mean mixed venous oxygen saturation).
Inclusion Criteria:
- ≤ 18 years old
- ≥ 2.5 kg and ≤ 40 kg weight
- Undergoing cardiac catheterization at Duke pediatric cardiac catheterization
laboratory
Exclusion Criteria:
- Known structural neurologic or craniofacial disease
- Arterial catheter placement not part of planned catheterization procedure
- Anemia (hemoglobin < 10 g/dl)
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