Performance Assessment of the PMD-200 in Subjects at Neurointensive Care Unit
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|ClinicalTrials.gov Identifier: NCT03452163|
Recruitment Status : Not yet recruiting
First Posted : March 2, 2018
Last Update Posted : March 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia, General||Device: PMD-200 Device: EEG monitor||Not Applicable|
The proposed study is design to further demonstrates the performance of the Nociception Level (NoL) Index in neurological impaired anesthetized patients under general anesthesia, by evaluating its response to controlled changes in the levels of noxious stimuli/analgesia, and to correlate the NoL response to the EEG derived pain score. Validating the performance of the NoL Index may provide a tool to monitor the pain/nociception in this population.
In this study, the PI plan to demonstrate that the NoL Index is a continuous index. It is anticipated that a higher level of nociception will correspond to a higher NoL index. On the other hand, it is anticipated that higher levels of analgesic agent for the same noxious stimulus will lead to a lower NoL index.
The participants will be monitored as in a typical ICU and according to the local guidelines by various types of monitoring devices, such as: vital signs, pulse oximeter, Bispectral Index (BIS), Electroencephalography (EEG) etc.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Performance Assessment of the Physiological Monitor Device (PMD-200), a Novel Pain Monitor, in Subjects at Neurointensive Care Unit (NICU).|
|Estimated Study Start Date :||March 15, 2018|
|Estimated Primary Completion Date :||April 30, 2018|
|Estimated Study Completion Date :||December 30, 2018|
Experimental: Anesthesia, General
Subjects under anesthesia that are expected to stay for at least 24 hours in the ICU/NICU will be monitored by the PMD-200 device. An EEG monitor device will be connected to the patient and display the Spectral Edge Frequency (SEF) signals and values on the subject monitor.
the patients will be monitored by PMD-200. The technology consists of measurements of a number of nociception-related physiological parameters that corresponds with the autonomic nervous system's response to noxious stimuli, and using the company's proprietary algorithms, 'translating' these measurements into an index that represents the nociceptive response, the NoL™ (Nociception Level) Index. The NoL index is a relative index from 0 to 100, while 0 is "no pain/nociception" and 100 is "extreme pain/nociception".
Device: EEG monitor
An EEG device will be connected to the patient and display the Spectral Edge Frequency (SEF) signals and values on the subject monitor.
- Correlation between changes in the nociception levels of the subject (NoL Index value) prior and following a noxious stimuli [ Time Frame: Through study completion, about one year ]To demonstrate that the NoL Index is correlates with changes in the nociception levels of the subject prior and following a noxious stimuli.
- Correlation between changes in the nociception levels of the subject (NoL Index value) to other nociception predictors (HR, NIBP) [ Time Frame: Through study completion, about one year ]The NoL values can be correlate to other nociception predictors (e.g heart rate, blood pressure) following a noxious stimuli.
- Correlation between the NoL index and the EEG derived pain score [ Time Frame: Through study completion, about one year ]To assess the correlation between the NoL index and the EEG derived pain score during arousal response caused by noxious stimuli
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): NCT03452163
|Contact: Merav Gat, M.Sc.||+972-73-7690321 ext email@example.com|
|Galil Medical Center|
|Principal Investigator:||Jean Soustiel, Prof.||Dept. of Neurosurgery Galilee Medical Center, Nahariya, Israel|