Study Stopped
Inability to support study performance
Performance Assessment of the PMD-200 in Subjects at Neurointensive Care Unit
1 other identifier
interventional
3
1 country
1
Brief Summary
Performance Assessment of the PMD-200, a Novel Pain Monitor, in Subjects at Neurointensive Care Unit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2018
CompletedFirst Posted
Study publicly available on registry
March 2, 2018
CompletedStudy Start
First participant enrolled
March 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2019
CompletedMay 6, 2021
March 1, 2020
1.7 years
January 21, 2018
May 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Correlation between changes in the nociception levels of the subject (NoL Index value) to other nociception predictors (HR, NIBP)
Through study completion, about one year
Correlation between the NoL index and the EEG derived pain score
Through study completion, about one year
Study Arms (1)
Anesthesia, General
EXPERIMENTALSubjects 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.
Interventions
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".
An EEG device will be connected to the patient and display the Spectral Edge Frequency (SEF) signals and values on the subject monitor.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- The subject is constantly agitate or moving a lot
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Galil Medical Center
Nahariya, Israel
Study Officials
- PRINCIPAL INVESTIGATOR
Jean Soustiel, Prof.
Dept. of Neurosurgery Galilee Medical Center, Nahariya, Israel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2018
First Posted
March 2, 2018
Study Start
March 8, 2018
Primary Completion
November 30, 2019
Study Completion
November 30, 2019
Last Updated
May 6, 2021
Record last verified: 2020-03