Validation of Next Generation Cerebral and Tissue Oximeter
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|ClinicalTrials.gov Identifier: NCT03128372|
Recruitment Status : Completed
First Posted : April 25, 2017
Results First Posted : November 9, 2018
Last Update Posted : November 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Oxygen Deficiency||Device: Desaturation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Validation of Next Generation INVOS NIRS Cerebral and Tissue Oximeter to Measure Cerebral and Somatic Tissue Oxygen Saturation in Healthy Volunteers|
|Actual Study Start Date :||May 22, 2017|
|Actual Primary Completion Date :||July 19, 2017|
|Actual Study Completion Date :||July 19, 2017|
Volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%.
The delivered gas mixture will be adjusted to decrease the displayed saturation of peripheral oxygen. Each desaturation steps are of approximately 5 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%.
Other Name: Cerebral and Tissue Oximeter
- Validated the Next Generation Oximeter [ Time Frame: Data collected from individual participant over 4 hour timeframe. ]Cerebral overall mean bias (percentage saturation) defined as the average of the differences between the regional saturation (rSO2) value and (fSO2) value obtained from simultaneous arterial and jugular venous blood samples. Cerebral trending is defined as the measurement of changes in regional saturation (rSO2) under conditions of changing fSO2. Cerebral trending mean bias is the average difference between changes in rSO2 values compared against changes in fSO2. Somatic trending mean bias is defined the same as Cerebral trending mean bias except for the location of measurement on the subjects and for Somatic trending mean bias, rS02 was compared to rSO2 on a commercially-available regional oximetry monitor. The smaller value the better performance.
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): NCT03128372
|United States, North Carolina|
|Duke University Hospital, HPPL|
|Durham, North Carolina, United States, 27710|
|Study Director:||Julia Katilius||Medtronic|