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

Not Applicable

Terminated

• Conditions: Anesthesia, General
• Interventions: Device: PMD-200; Device: EEG monitor

• Registration Number: NCT03452163
• Lead Sponsor: Medasense Biometrics Ltd

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-01-21
• Study First Submitted QC: 2018-02-25
• Study First Posted: 2018-03-02
• Study Start: 2018-03-08
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Status Verified: 2020-03
• Last Update Submitted: 2021-05-02
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anesthesia, General	PMD-200	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.
Anesthesia, General	EEG monitor	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Correlation between the NoL index and the EEG derived pain score	Through study completion, about one year	To assess the correlation between the NoL index and the EEG derived pain score during arousal response caused by noxious stimuli
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	The NoL values can be correlate to other nociception predictors (e.g heart rate, blood pressure) following a noxious stimuli.

Trial Locations

Locations (1)

Galil Medical Center; 🇮🇱 Nahariya, Israel