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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04581642
Other study ID # CLI-01-1-09
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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