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).

Status Terminated

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anesthesia, General

• NCT number: NCT03452163
• Study type: Interventional
• Source: Medasense Biometrics Ltd
• Status: Terminated
• Phase: N/A
• Start date: March 8, 2018
• Completion date: November 30, 2019