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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-11-30

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.

Detailed Description

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Conditions

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Pain Opioid Use Dementia Unconscious Ventilator Lung

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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)

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adi Sasson, Dr.

Role: PRINCIPAL_INVESTIGATOR

DOROT, Netanya Geriatric Medical Center

Locations

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Dorot Netanya Gariatric Medical Center

Netanya, , Israel

Site Status

Countries

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Israel

Other Identifiers

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CLI-01-1-09

Identifier Type: -

Identifier Source: org_study_id