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

Anesthesia, General Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03452163
• Other study ID #: CLI-16-03
• Status: Terminated
• Phase: N/A
• Start date: March 8, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: March 2020
• Source: Medasense Biometrics Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

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".
• 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.

Locations

Country	Name	City	State
Israel	Galil Medical Center	Nahariya

Sponsors (1)

Lead Sponsor	Collaborator
Medasense Biometrics Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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