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Performance Assessment of the PMD-200 in Subjects Requiring Surgery Under General Anesthesia

NCT03466138 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2021-05-04

No results posted yet for this study

Summary

The proposed study is designed to further demonstrate the performance of the Nociception Level (NoL) Index - in surgical patient under general anesthesia, by evaluating its response to controlled changes in the levels of noxious stimuli/analgesia and to correlate early outcome predictors to the NoL values throughout the surgical procedure, thus provide the medical caregiver general recommendations on how to interpret the NoL Index in terms of magnitude and direction, and how to utilize it during the surgical procedure.

Conditions

  • Anesthesia

Interventions

DEVICE

PMD-200

The PMD-200 system 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)

Sponsors & Collaborators

  • Medasense Biometrics Ltd

    lead OTHER

Principal Investigators

  • Tibi Ezri, Prof. · Wolfson Medical Center

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-13
Primary Completion
2020-12-01
Completion
2020-12-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03466138 on ClinicalTrials.gov