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

NCT03466138 | Completed

• 1 other identifier: CLI-16-02
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• demonstrate the NoL Index correlation prior and following a noxious stimuli.

  The primary objective is to demonstrate the NoL Index is correlates with changes in the nociception levels of the subject during the surgical procedure prior and following a noxious stimuli.

  Through study completion, about one year

Secondary Outcomes (1)

• Correlation between the NoL Index and other nociception predictors (such as heart rate - Beats per Minute) following a noxious stimuli.

  Through study completion, about one year

Study Arms (1)

General Anesthesia

subjects requiring a surgical procedure under general anesthesia. monitored by PMD-200

Device: PMD-200

Interventions

PMD-200 DEVICE

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)

General Anesthesia

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes subjects requiring a surgical procedure under general anesthesia.

You may qualify if:

• The subject age is \> 18 years old
• The subject requires surgery under general anesthesia.
• A blood pressure measurement (via arterial line or cuff) will be available during the surgical procedure.
• The subject signed an Informed Consent Form (ICF)

You may not qualify if:

• History of severe cardiac arrhythmias within the last 12 months
• Pregnancy or lactation
• Chronic pain conditions or analgesic usage (\> 1 month of large doses of opioids: more than 30mg PO equivalent of morphine)

Sponsors & Collaborators

• Medasense Biometrics Ltd: lead

Study Sites (1)

Wolfson Medical Center

Holon, 5822012, Israel

Location

Study Officials

• Tibi Ezri, Prof.

  Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: March 15, 2018
• Study Start: December 13, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 4, 2021

Record last verified: 2021-04

Locations

IL (1)