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

Medasense

Status: Terminated

Conditions: Anesthesia, General

Treatments: Device: PMD-200; Device: EEG monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT03452163

CLI-16-03

Details and patient eligibility

About

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

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Anesthesia, General

Experimental group

Description:

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.

Treatment:

Device: EEG monitor

Device: PMD-200