Accuracy of the O2 MedTech PMS-3000 Monitor

This study has been completed.
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
O2 MedTech, Inc.
ClinicalTrials.gov Identifier:
NCT01418079
First received: August 12, 2011
Last updated: May 21, 2012
Last verified: May 2012
  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 Phase
Healthy
Device: O2 MedTech cerebral oximeter (Oxygen desaturation)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Accuracy of the O2 MedTech PMS-3000 Monitor for the Non-invasive Measurement of Cerebral and Tissue Oxygenation Using Phase-modulated Infrared Spectroscopy

Resource links provided by NLM:


Further study details as provided by O2 MedTech, Inc.:

Primary Outcome Measures:
  • Accuracy of device to measure cerebral tissue oxygen saturation [ Time Frame: approximately 4 months ] [ Designated as safety issue: No ]
    Oximeter measurements are compared to co-oximeter measurements following each subject study. The total sample of subjects is needed to complete the analysis.


Enrollment: 42
Study Start Date: August 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PMS-3000
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)
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: PMS-3000 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 versus 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%. Several 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 also maintaining the arterial carbon dioxide level at a precise level.

The study consists of 2 sequences:

  • First sequence: reduction in arterial oxygen saturation in approximately 5% increments from 100 to 70%, while maintaining the arterial carbon dioxide level at 40 mmHg, followed by return to room air and then a period of supplemental oxygen.
  • Second sequence: reduction in arterial oxygen saturation in approximately 5% increments from 100 to 70%, while maintaining the arterial carbon dioxide level at a different level, followed by return to room air and then a period of supplemental oxygen.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Female with positive pregnancy test
  2. Beard or history of or anatomy suggestive of difficult airway
  3. Lab values outside normal range for the clinical site
  4. History of cigarette smoking or currently a cigarette smoker
  5. Current drug or alcohol abuse
  6. History of sleep apnea, high blood pressure (HBP), cardiac or pulmonary disease, gastroesophageal reflux, hemoglobinopathy, or coagulation abnormality
  7. Known allergy to lidocaine or heparin
  8. Abnormal electrocardiogram (ECG)
  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: NCT01418079

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
O2 MedTech, Inc.
Duke University
Investigators
Principal Investigator: David B MacLeod, FRCA Duke University
  More Information

No publications provided

Responsible Party: O2 MedTech, Inc.
ClinicalTrials.gov Identifier: NCT01418079     History of Changes
Other Study ID Numbers: MT2010001
Study First Received: August 12, 2011
Last Updated: May 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by O2 MedTech, Inc.:
Spectroscopy, near infrared
cerebral oxygenation

ClinicalTrials.gov processed this record on October 01, 2014