Validation of Brain Oxygenation Monitor

This study has been completed.
Sponsor:
Collaborator:
Nonin Medical, Inc
Information provided by (Responsible Party):
David MacLeod, Duke University
ClinicalTrials.gov Identifier:
NCT00815490
First received: December 26, 2008
Last updated: March 6, 2013
Last verified: March 2013
  Purpose

A cerebral oximeter is a device that uses light to measure the amount of oxygen within the brain. It is similar to the device that measures the level of oxygen in the tip of the finger, known as a pulse oximeter. The cerebral oximeter consists of a sensor placed on the forehead that both emits and detects the amount of light absorbed. This study will determine how accurate the device is by comparing the displayed value on the monitor with blood samples taken simultaneously from the arterial blood in the wrist and venous blood in the neck. In order to test the device over a suitable range, the level of oxygen within the blood will be reduced in a controlled manner by reduction of the inspired oxygen concentration. This is the equivalent of ascending to an altitude of 16,000 feet. The study will be conducted in healthy volunteers.


Condition Intervention
Healthy
Device: Desaturation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Calibration and Validation of the Nonin Non-invasive Cerebral Oxygen Saturation Oximeter and Cerebral Sensor in Human Volunteers

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Accuracy of Sensor [ Time Frame: Data collected from individual participants over 1 hour timeframe. Data from cohort of subjects collected over 6 month period. ] [ Designated as safety issue: No ]
    A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around this line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square or ARMS. The smaller the ARMS the closer the data points lie around the line of identity, representing a more accurate sensor.


Enrollment: 18
Study Start Date: June 2008
Study Completion Date: April 2012
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Desaturation
Human volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%.
Device: Desaturation
Reduction in blood oxygen saturation by sequential reduction in inspired gas composition. Steps are of 6 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%.
Other Name: Nonin cerebral oximeter

Detailed Description:

This is a calibration and validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation non-invasively. This is achieved by comparing NIRS-derived cerebral tissue oxygen saturation with a calculated value derived from simultaneous arterial and jugular venous blood samples.

At present the FDA have adopted the standards published in 2005 by the International Organization for Standardization (ISO), entitled ISO 9919. This is a set of technical specifications and guidelines for pulse oximeters, which share certain technical similarities to cerebral oximeters. In particular, Annex EE details the conduct of a controlled desaturation study for the calibration of pulse oximeter equipment. Specifically, the fraction of inspired oxygen delivered to test subjects is varied to achieve a series of targeted steady state saturation periods over a range of arterial oxygen saturation of 70 - 100%.

While cerebral oximeters differ from pulse oximeters in terms of the what is being measured (brain tissue v arterial blood) the FDA have maintained the requirement to examine data from human volunteer studies in which the arterial oxygen saturation ranges from 70 - 100%. Two FDA-approved cerebral oximeters were validated in a similar manner.

The device controlling the inspired gas concentration is the RespirAct, which permits precise reduction in the arterial oxygen saturation while maintaining the arterial carbon dioxide level at 40 mmHg.

The study consists of 3 sequences:

  • First sequence: reduction in arterial oxygen saturation in approximately 5% increments from 100 to 70% followed by return to room air and then a period of supplemental oxygen.
  • Second sequence: reduction in arterial oxygen saturation in a single drop from 100 to 70% followed by return to room air and then a period of supplemental oxygen.
  • Third sequence: reduction in arterial oxygen saturation in approximately 10% increments from 100 to 70% with alteration of carbon dioxide level from 35 to 45 mmHg at each interval followed by return to room air.
  Eligibility

Ages Eligible for Study:   21 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 21 to 35 years
  • American Society of Anesthesiologists health assessment level 1
  • Body Mass Index (BMI) 18 to 30

Exclusion Criteria:

  • anemia
  • hemoglobinopathy (e.g. sickle cell disease, thalassemia)
  • positive pregnancy test (females)
  • significant cardiac or pulmonary disease
  • history of sleep apnea
  • tobacco, drug or alcohol abuse
  • difficult airway
  • abnormal EKG / pulmonary function test / room air saturation
  • intolerance to breathing mask apparatus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815490

Locations
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Nonin Medical, Inc
Investigators
Principal Investigator: David B MacLeod, FRCA Duke University Health System
  More Information

Publications:
Responsible Party: David MacLeod, Assistant Clinical professor, Duke University
ClinicalTrials.gov Identifier: NCT00815490     History of Changes
Other Study ID Numbers: Pro00002400
Study First Received: December 26, 2008
Results First Received: November 19, 2012
Last Updated: March 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Spectroscopy, near infrared
Oximetry
Hypoxemia
Tissue oxygenation

ClinicalTrials.gov processed this record on October 23, 2014