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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00849940
Other study ID # Pro00009391
Secondary ID
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


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
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