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

• Sponsor: Medasense Biometrics Ltd (Other)
• Overall Status: Completed
• CT.gov ID: NCT04581642
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Actual Duration (Months): 12.9
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Opioid Use; Dementia; Unconscious; Ventilator Lung	Device: PMD200

Study Design

• Study Type: Observational
• Actual Enrollment: 33 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Nov 1, 2020
• Actual Primary Completion Date: Aug 30, 2021
• Actual Study Completion Date: Nov 30, 2021

Outcome Measures

Primary Outcome Measures

1. Efficacy outcome [5 months]

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

2. Efficacy outcome [5 months]

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

3. Efficacy outcome [5 months]

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

4. Efficacy outcome [10 months]

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

Secondary Outcome Measures

1. Efficacy outcome [10 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dorot Netanya Gariatric Medical Center	Netanya		Israel	42420

Sponsors and Collaborators

• Medasense Biometrics Ltd

Investigators

• Principal Investigator: Adi Sasson, Dr., DOROT, Netanya Geriatric Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medasense Biometrics Ltd
• ClinicalTrials.gov Identifier: NCT04581642
• Other Study ID Numbers: CLI-01-1-09
• First Posted: Oct 9, 2020
• Last Update Posted: Dec 14, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dementia; Unconsciousness

Study Results

No Results Posted as of Dec 14, 2021