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Completed

NCT Number: NCT04581642

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

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.

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Key information

Conditions

Pain Brain Diseases Central Nervous System Diseases Consciousness Disorders Dementia Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Opioid Use Pathological Conditions, Signs and Symptoms Signs and Symptoms Unconscious Unconsciousness Ventilator Lung

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dorot Netanya Gariatric Medical Center

Netanya, 42420, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  1. Efficacy outcome

    Time frame: 5 months

    To identify what information is currently elicited and used by clinicians when detecting and managing pain.

  2. Efficacy outcome

    Time frame: 5 months

    To assess the feasibility of the current NOL algorithm (PMD200 vs. NOLedge) for pain management in the study population.

  3. Efficacy outcome

    Time frame: 5 months

    To collect data to improve the performance of the NOL algorithm in the study population

  4. Efficacy outcome

    Time frame: 10 months

    The ability of the NOL index to discriminate between periods of painful and non-painful periods

Secondary outcomes

  1. Efficacy outcome

    Time frame: 10 months

    NOL-index performance to detect pain in comparison to PAINAD, BPS pain scores

Sponsors and collaborators

Lead sponsor

Medasense Biometrics Ltd

Other

Registry information

Official study title

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

Acronym: MoNOLog

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 9, 2020
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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