Clinical trial NCT00849940: Validation of Brain Oxygenation Monitor on Pediatric Patients
Official title: Validation of the CAS Medical System, Inc. FORE-SIGHT Near-Infrared Spectroscopy (NIRS) Monitor in Pediatric Subjects for Viscerosomatic Applications
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiac Catheterization
Keywords: Spectroscopy
Near infrared
Oximetry
Hypoxemia
Tissue oxygenation
Pediatric
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: CAS Medical Systems, Inc.
First posted: 2009-02-24
Enrollment: 72
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Accuracy of NIRS Sensor to Estimate Flank Tissue Oxygen Saturation
timeFrame: Data collected from individual participants over 4 hour timeframe.
measure: Accuracy of NIRS Sensor to Estimate Intestine Tissue Oxygen Saturation
timeFrame: Data collected from individual participants over 4 hour timeframe.
measure: Accuracy of NIRS Sensor to Estimate Hepatic Tissue Oxygen Saturation
timeFrame: Data collected from individual participants over 4 hour timeframe.
Secondary outcomes:
measure: Correlation Between Somatic StO2 and Cerebral SctO2 Oxygen Saturation
timeFrame: Data collected from individual participants over 4 hour timeframe
measure: Correlation Between NIRS Derived Estimate of Hemoglobin Concentration and Measured Arterial Blood Hemoglobin Concentration.
timeFrame: Data collected from individual participants over 4 hour timeframe
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke Health
name: David B MacLeod, FCRA
role: PRINCIPAL_INVESTIGATOR
References: