Validation of Brain Oxygenation Monitor on Pediatric Patients

Cardiac Catheterization Clinical Trial

Official title:

Validation of the CAS Medical System, Inc. FORE-SIGHT Near-Infrared Spectroscopy (NIRS) Monitor in Pediatric Subjects for Viscerosomatic Applications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00849940
• Other study ID #: Pro00009391
• Status: Recruiting
• Phase: N/A
• First received: January 22, 2009
• Last updated: November 3, 2014
• Start date: February 2009
• Est. completion date: December 2016

Study information

• Verified date: August 2014
• Source: Duke University
• Contact: David MacLeod, FRCA
• Phone: 919-812-3201
• Email: david.macleod[@]duke.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cardiac Catheterization

Intervention

Device:
• CAS NIRS FORE-SIGHT oximeter
Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation.

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	CAS Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of sensor	Correlation between displayed tissue sensor value and measured blood values of tissue oxygen saturation, from which the degree of sensor accuracy is derived.	Data collected from individual participants over 4 hour timeframe. Data from cohort of subjects collected over 24 month period.	No
Primary	Degree of concordance between NIRS StO2 and mean mixed venous oxygen saturation		Data collected from individual participants over 4 hour timeframe.	No
Secondary	Difference between NIRS viscerosomatic StO2 and NIRS cerebral SctO2		Data collected from individual participants over 4 hour timeframe.	No
Secondary	Degree of concordance between NIRS hemoglobin concentration per volume of viscerosomatic tissue (TotalHb) and hematocrit (HCT) /hemoglobin (HGB) measured from arterial blood.		Data collected from individual participants over 4 hour timeframe.	No