NCT03276260

Evaluation of Medasense's PMD-200 During Surgery and Post Anesthesia Care

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: Medasense Biometrics Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Medasense's Pain Monitoring Device (PMD) is a novel non-invasive, bedside stand alone, continuous monitor that is designed to provide real-time information about changes in the nociception level of patients under general anesthesia during surgical procedures. The PMD-200 System is based on real-time data acquisition and processing of physiological signals. The system displays the NOL index (a single numerical index) which is computed from recorded physiological parameters based on a proprietary algorithm.

Detailed description

The aim of this observational study is to evaluate the pattern of the NOL index during surgery in the anesthetized patient and during the post-operative period in the awake patient. Up to 100 patients scheduled for elective surgery under general, regional and local anesthesia and sedation, who meet all the inclusion and none of the exclusion criteria, will be enrolled after signing informed consent.

Conditions

• Surgery
• Nociceptive Pain
• Postoperative Pain

Interventions

Type	Name	Description
DEVICE	PMD-200	Patient will be connected to PMD-200 by finger-probe before induction of anesthesia or sedation. Recording will continue during surgery until extubation or awakening. Recording will be initiated again as soon as the patient arrives to the PACU until discharge to the surgical ward or home.

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-04-30
• Completion: 2019-04-30
• First posted: 2017-09-08
• Last updated: 2020-03-11

Locations

1 site across 1 country: Israel