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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Dementia; Opioid Use; Ventilator Lung; Unconscious
• Intervention / Treatment: Device: PMD200

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Israel
  • Netanya, Israel, 42420
    • Dorot Netanya Gariatric Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a clinical syndrome due to disease of a progressive nature, which leads to disturbances in multiple higher cortical functions, including memory, thinking, orientation, comprehension, calculation, learning capacity, language and judgment;

1. Older adults with advanced dementia;
2. Critically ill/unconscious patients;
3. Patients at the end of life stage.
4. Ventilated patients.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medasense Biometrics Ltd
• Investigators: Principal Investigator: Adi Sasson, Dr., DOROT, Netanya Geriatric Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2020
• Primary Completion (ACTUAL): August 30, 2021
• Study Completion (ACTUAL): November 30, 2021

Study Registration Dates

• First Submitted: October 3, 2020
• First Submitted That Met QC Criteria: October 3, 2020
• First Posted (ACTUAL): October 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 14, 2021
• Last Update Submitted That Met QC Criteria: December 12, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Consciousness Disorders; Dementia; Unconsciousness
• Other Study ID Numbers: CLI-01-1-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No