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

Performance Assessment of the Physiological Monitor Device (PMD-200), a Novel Pain Monitor, in Subjects at Neurointensive Care Unit (NICU).

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

Study Overview

• Status: Terminated
• Conditions: Anesthesia, General
• Intervention / Treatment: Device: PMD-200; Device: EEG monitor

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Nahariya, Israel
    • Galil Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between changes in the nociception levels of the subject (NoL Index value) prior and following a noxious stimuli	To demonstrate that the NoL Index is correlates with changes in the nociception levels of the subject prior and following a noxious stimuli.	Through study completion, about one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between changes in the nociception levels of the subject (NoL Index value) to other nociception predictors (HR, NIBP)	The NoL values can be correlate to other nociception predictors (e.g heart rate, blood pressure) following a noxious stimuli.	Through study completion, about one year
Correlation between the NoL index and the EEG derived pain score	To assess the correlation between the NoL index and the EEG derived pain score during arousal response caused by noxious stimuli	Through study completion, about one year

Collaborators and Investigators

• Sponsor: Medasense Biometrics Ltd
• Investigators: Principal Investigator: Jean Soustiel, Prof., Dept. of Neurosurgery Galilee Medical Center, Nahariya, Israel

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2018
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: January 21, 2018
• First Submitted That Met QC Criteria: February 25, 2018
• First Posted (Actual): March 2, 2018

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 2, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CLI-16-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No