Performance Assessment of the PMD-200 in Subjects at Neurointensive Care Unit

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-08

Study Completion Date

2019-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Anesthesia, General

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PMD-200

Intervention Type DEVICE

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".

EEG monitor

Intervention Type DEVICE

An EEG device will be connected to the patient and display the Spectral Edge Frequency (SEF) signals and values on the subject monitor.

Interventions

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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".

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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