Validation of Brain Oxygenation Monitor on Pediatric Patients

NCT00849940 | Terminated Results

• 1 other identifier: Pro00009391
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Catheterization

Keywords

Spectroscopy; Near infrared; Oximetry; Hypoxemia; Tissue oxygenation; Pediatric

Outcome Measures

Primary Outcomes (3)

• Accuracy of NIRS Sensor to Estimate Flank Tissue Oxygen Saturation

  The flank tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of flank tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the flank tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other. oxygen saturation when measured displayed NIRS value of the tissue sensor placed over the flank to a reference CO-oximetry model, reported as bias and precision. The model is weighted as 30:70 arterial: central venous oxygen saturation when measured by blood gas co-oximetry.

  Data collected from individual participants over 4 hour timeframe.

• Accuracy of NIRS Sensor to Estimate Intestine Tissue Oxygen Saturation

  The intestine tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of intestine tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the intestine tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other.

  Data collected from individual participants over 4 hour timeframe.

• Accuracy of NIRS Sensor to Estimate Hepatic Tissue Oxygen Saturation

  The hepatic tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of hepatic tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the hepatic tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other.

  Data collected from individual participants over 4 hour timeframe.

Secondary Outcomes (2)

• Correlation Between Somatic StO2 and Cerebral SctO2 Oxygen Saturation

  Data collected from individual participants over 4 hour timeframe

• Correlation Between NIRS Derived Estimate of Hemoglobin Concentration and Measured Arterial Blood Hemoglobin Concentration.

  Data collected from individual participants over 4 hour timeframe

Study Arms (1)

CAS NIRS FORE-SIGHT oximeter

EXPERIMENTAL

Pediatric patients presenting for cardiac catheterization.

Device: CAS NIRS FORE-SIGHT oximeter

Interventions

CAS NIRS FORE-SIGHT oximeter DEVICE

Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation.

CAS NIRS FORE-SIGHT oximeter

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ≤ 18 years old
• ≥ 2.5 kg and ≤ 40 kg weight
• Undergoing cardiac catheterization at Duke pediatric cardiac catheterization laboratory

You may not qualify if:

• Known structural neurologic or craniofacial disease
• Arterial catheter placement not part of planned catheterization procedure
• Anemia (hemoglobin \< 10 g/dl)

Sponsors & Collaborators

• Duke University: lead
• CAS Medical Systems, Inc.: collaborator

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Blood samples collected from pediatric patients undergoing cardiac catheterization. Venous blood samples taken from within IVC as close to the tissue of interest.

Results Point of Contact

• Title: David MacLeod, M.B.
• Organization: Duke University Medical Center

david.macleod@dm.duke.edu

919-681-3551

Study Officials

• David B MacLeod, FCRA

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: February 24, 2009
• Study Start: February 1, 2009
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: February 9, 2017
• Results First Posted: March 28, 2016

Record last verified: 2016-02

Locations

US (1)