NCT01762722

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 8, 2013

Completed
3 months until next milestone

Results Posted

Study results publicly available

April 16, 2013

Completed
Last Updated

April 16, 2013

Status Verified

March 1, 2013

Enrollment Period

9 months

First QC Date

February 17, 2012

Results QC Date

March 6, 2013

Last Update Submit

March 6, 2013

Conditions

Healthy

Keywords

Spectroscopy, near infraredOximetryHypoxemiaTissue oxygenation

Outcome Measures

Primary Outcomes (1)

  • Accuracy of Sensor

    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.

    Data collected from individual participants over 1 hour timeframe. Data from cohort of subjects collected over 6 month period.

Study Arms (1)

Desaturation

EXPERIMENTAL

Human volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%.

Device: Reduction of inspired oxygen

Interventions

Reduction of inspired oxygenDEVICE

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%.

Also known as: Nonin Equanox cerebral oximeter
Desaturation

Eligibility Criteria

Age21 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • MacLeod DB, Ikeda K, Vacchiano C, Lobbestael A, Wahr JA, Shaw AD. Development and validation of a cerebral oximeter capable of absolute accuracy. J Cardiothorac Vasc Anesth. 2012 Dec;26(6):1007-14. doi: 10.1053/j.jvca.2012.06.010. Epub 2012 Aug 9.

    PMID: 22883447RESULT

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr David MacLeod
Organization
Duke University Medical Center
david.macleod@duke.edu
919-812-3201

Study Officials

  • David B MacLeod, FRCA

    Duke Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Clinical professor

Study Record Dates

First Submitted

February 17, 2012

First Posted

January 8, 2013

Study Start

September 1, 2009

Primary Completion

June 1, 2010

Study Completion

April 1, 2012

Last Updated

April 16, 2013

Results First Posted

April 16, 2013

Record last verified: 2013-03

Locations

US(1)