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

Completed

• Conditions: Ventilator Lung; Unconscious; Opioid Use; Dementia; Pain

• Registration Number: NCT04581642
• Lead Sponsor: Medasense Biometrics Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-03
• Study First Submitted QC: 2020-10-03
• Study First Posted: 2020-10-09
• Study Start: 2020-11-01
• Primary Completion: 2021-08-30
• Study Completion: 2021-11-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-12
• Last Update Posted: 2021-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy outcome	10 months	The ability of the NOL index to discriminate between periods of painful and non-painful periods

Secondary Outcome Measures

Name	Time	Method
Efficacy outcome	10 months	NOL-index performance to detect pain in comparison to PAINAD, BPS pain scores

Trial Locations

Locations (1)

Dorot Netanya Gariatric Medical Center; 🇮🇱 Netanya, Israel