Nociception-Level (NOL) for the Assessment of Pain in Patient Unable to Self-Report

Study Overview
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Brief Summary
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In this study we aimed to investigate the performance and effectiveness of NOL and/or NOLedge as a tool for pain assessment in geriatric and critical ill non communicating patients. Our hypothesis was that NOL and the NOLedge may have good correlation with the health-care professional assessment PAINAD, BPS values, even with the use of the drugs affecting autonomic nervous system.

Official Title
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Nociception-Level (NOL) for the Assessment of Pain in Patient Unable to Self-Report: An Exploratory, Prospective, Unblinded, Single-center Study- The MoNOLog Study

Conditions
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Dementia, Pain, Opioid Use, Unconscious, Ventilator Lung

Intervention / Treatment
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* Device: PMD200


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female, Age > 18 years old. Spontaneously breathing or mechanically ventilated Any patient who is unable to express his/her own level of personal pain by using visual scales according to the hospital standard Written informed consent provided by the participant (if they have capacity) or guardian (if they do not have capacity) or a written proxy informed consent from a legally authorized representative empowered to make health-related decisions for the potential study participant. Exclusion Criteria: A patient whose staff or research team believes that his or her participation in the research will cause suffering to the patient. Unstable condition preventing planned routine procedures of care, and conditions precluding the use of PMD-200: absence of sinus cardiac rhythm.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PMD200|The NOL technology is comprised of a console and designated finger probe with 4 sensors. The Sensors are Photoplethysmography (PPG) Galvanic Skin Response (GSR), Accelerometer (ACC) and Thermistor (TMP)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy outcome | To identify what information is currently elicited and used by clinicians when detecting and managing pain. | 5 months | 
| Efficacy outcome | To assess the feasibility of the current NOL algorithm (PMD200 vs. NOLedge) for pain management in the study population. | 5 months | 
| Efficacy outcome | To collect data to improve the performance of the NOL algorithm in the study population | 5 months | 
| Efficacy outcome | The ability of the NOL index to discriminate between periods of painful and non-painful periods | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy outcome | NOL-index performance to detect pain in comparison to PAINAD, BPS pain scores | 10 months |