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

NCT04581642 | Completed DMC

• 1 other identifier: CLI-01-1-09
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Opioid Use; Dementia; Unconscious; Ventilator Lung

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Efficacy outcome

  10 months

Interventions

PMD200 DEVICE

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medasense Biometrics Ltd: lead

Study Sites (1)

Dorot Netanya Gariatric Medical Center

Netanya, 42420, Israel

Location

MeSH Terms

Conditions

Pain; Dementia; Unconsciousness

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Consciousness Disorders; Neurobehavioral Manifestations

Study Officials

• Adi Sasson, Dr.

  DOROT, Netanya Geriatric Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2020
• First Posted: October 9, 2020
• Study Start: November 1, 2020
• Primary Completion: August 30, 2021
• Study Completion: November 30, 2021
• Last Updated: December 14, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)