NCT04581642CompletedNot 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 enrollmentStarted: November 1, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medasense Biometrics Ltd
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Efficacy outcome
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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.
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)
Investigators
Study Sites (1)
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