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

Pain Clinical Trial

— MoNOLog  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04581642
• Other study ID #: CLI-01-1-09
• Status: Completed
• Start date: November 1, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: December 2021
• Source: Medasense Biometrics Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Opioid Use
• Pain
• Unconscious
• Unconsciousness
• Ventilator Lung

Intervention

Device:
• 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)

Locations

Country	Name	City	State
Israel	Dorot Netanya Gariatric Medical Center	Netanya

Sponsors (1)

Lead Sponsor	Collaborator
Medasense Biometrics Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy outcome	To identify what information is currently elicited and used by clinicians when detecting and managing pain.	5 months
Primary	Efficacy outcome	To assess the feasibility of the current NOL algorithm (PMD200 vs. NOLedge) for pain management in the study population.	5 months
Primary	Efficacy outcome	To collect data to improve the performance of the NOL algorithm in the study population	5 months
Primary	Efficacy outcome	The ability of the NOL index to discriminate between periods of painful and non-painful periods	10 months
Secondary	Efficacy outcome	NOL-index performance to detect pain in comparison to PAINAD, BPS pain scores	10 months