Accuracy of the O2 MedTech PMS-3000 Monitor
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|ClinicalTrials.gov Identifier: NCT01418079|
Recruitment Status : Completed
First Posted : August 16, 2011
Last Update Posted : May 23, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Device: O2 MedTech cerebral oximeter (Oxygen desaturation)||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418079
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||David B MacLeod, FRCA||Duke University|