- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01418079
Accuracy of the O2 MedTech PMS-3000 Monitor
Accuracy of the O2 MedTech PMS-3000 Monitor for the Non-invasive Measurement of Cerebral and Tissue Oxygenation Using Phase-modulated Infrared Spectroscopy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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%.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of device to measure cerebral tissue oxygen saturation
Time Frame: approximately 4 months
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MT2010001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on O2 MedTech cerebral oximeter (Oxygen desaturation)
-
Duke UniversityNonin Medical, IncCompleted
-
Medtronic - MITGCompleted
-
Duke UniversityNonin Medical, IncCompleted
-
University of AthensCompletedCerebral Oxygen Saturation During Spinal Anesthesia for Cesarean DeliveryGreece
-
Prince Sultan Military Medical CityRecruitingCerebral OxygenationSaudi Arabia