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Clinical Trials/NCT04581642
NCT04581642
Completed
Not Applicable

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

Medasense Biometrics Ltd1 site in 1 country33 target enrollmentNovember 1, 2020
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ConditionsPainOpioid UseDementiaUnconsciousVentilator Lung

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Medasense Biometrics Ltd
Enrollment
33
Locations
1
Primary Endpoint
Efficacy outcome
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2020
End Date
November 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Efficacy outcome

Time Frame: 10 months

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

Secondary Outcomes

  • Efficacy outcome(10 months)

Study Sites (1)

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