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

NCT03452163 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-05-06

No results posted yet for this study

Summary

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

Conditions

  • Anesthesia, General

Interventions

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.

Sponsors & Collaborators

  • Medasense Biometrics Ltd

    lead OTHER

Principal Investigators

  • Jean Soustiel, Prof. · Dept. of Neurosurgery Galilee Medical Center, Nahariya, Israel

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-08
Primary Completion
2019-11-30
Completion
2019-11-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03452163 on ClinicalTrials.gov