Pain Clinical Trial
— MoNOLogOfficial 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
Verified date | December 2021 |
Source | Medasense Biometrics Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Israel | Dorot Netanya Gariatric Medical Center | Netanya |
Lead Sponsor | Collaborator |
---|---|
Medasense Biometrics Ltd |
Israel,
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 |
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