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Trial record 68 of 83269 for:    subjects

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
Sponsor:
Information provided by (Responsible Party):
Medasense Biometrics Ltd

Brief Summary:
Performance Assessment of the PMD-200, a Novel Pain Monitor, in Subjects at Neurointensive Care Unit.

Condition or disease Intervention/treatment Phase
Anesthesia, General Device: PMD-200 Device: EEG monitor Not Applicable

Detailed Description:

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.


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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

Arm Intervention/treatment
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.
Device: PMD-200
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years old.
  • The subject is under general anesthesia
  • The subject have a blood pressure measurement (either arterial or cuff) during the study
  • A signed Informed Consent Form (ICF) has been obtain

Exclusion Criteria:

- The subject is constantly agitate or moving a lot


Information from the National Library of Medicine

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


Contacts
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Contact: Merav Gat, M.Sc. +972-73-7690321 ext 216 merav@medasense.com

Locations
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Israel
Galil Medical Center
Nahariya, Israel
Sponsors and Collaborators
Medasense Biometrics Ltd
Investigators
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Principal Investigator: Jean Soustiel, Prof. Dept. of Neurosurgery Galilee Medical Center, Nahariya, Israel

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Responsible Party: Medasense Biometrics Ltd
ClinicalTrials.gov Identifier: NCT03452163     History of Changes
Other Study ID Numbers: CLI-16-03
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No