Accuracy of the O2 MedTech PMS-3000 Monitor

NCT01418079 | Completed Phase 2

• 1 other identifier: MT2010001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Spectroscopy, near infrared; cerebral oxygenation

Outcome Measures

Primary Outcomes (1)

• Accuracy of device to measure cerebral tissue oxygen saturation

  Oximeter measurements are compared to co-oximeter measurements following each subject study. The total sample of subjects is needed to complete the analysis.

  approximately 4 months

Study Arms (1)

PMS-3000

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: O2 MedTech cerebral oximeter (Oxygen desaturation)

Interventions

O2 MedTech cerebral oximeter (Oxygen desaturation) DEVICE

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: PMS-3000 cerebral oximeter

PMS-3000

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index (BMI) of 18 to 30, inclusive
• No anticoagulant or platelet inhibitor use
• Oxygen saturation (SpO2) ≥ 95% on room air
• Able to tolerate breathing mask apparatus

You may not qualify if:

• Female with positive pregnancy test
• Beard or history of or anatomy suggestive of difficult airway
• Lab values outside normal range for the clinical site
• History of cigarette smoking or currently a cigarette smoker
• Current drug or alcohol abuse
• History of sleep apnea, high blood pressure (HBP), cardiac or pulmonary disease, gastroesophageal reflux, hemoglobinopathy, or coagulation abnormality
• Known allergy to lidocaine or heparin
• Abnormal electrocardiogram (ECG)

Sponsors & Collaborators

• O2 MedTech, Inc.: lead
• Duke University: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Study Officials

• David B MacLeod, FRCA

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2011
• First Posted: August 16, 2011
• Study Start: August 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: May 23, 2012

Record last verified: 2012-05

Locations

US (1)