Assessment of Pain in Surgical Patient by PMD 200

August 16, 2017 updated by: Guy Elad, Meir Hospital, Kfar Saba, Israel
The trial will estimate post-operative pain management in elective surgical patients using the PMD-200 device. The device measures physiological parameters by placing a non-invasive sensor on a fingertip and displays an objective pain level in a 0-100 scale. The pain level will be estimated before surgery (baseline), after surgery and during administration of parenteral analgesia. Treatment and analgesia will be given according to clinical considerations and standard ward protocols. The device measurements won't influence the treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Detailed Description

  1. Background The key to adequate pain management is assessing its presence, duration and severity, identifying those who require intervention, and evaluating the treatment efficacy. Pain relates to both the noxious input, via peripheral nerves, and to central modulation, thereby, integrating different modalities such as affect, experience or personality. Nociception refers to the peripheral and central nervous system (CNS) processing of information about the internal or external environment, as generated by activation of nociceptors. Typically, noxious stimuli, including tissue injury, activate nociceptors that are present in peripheral structures and that transmit information to the spinal cord dorsal horn (or its trigeminal homologue - the nucleus caudalis). From there, the information continues to the brainstem and ultimately the cerebral cortex, where the perception of pain is generated. The pain is a product of higher brain center processing, whereas nociception can occur in the absence of pain.

    Objective assessment of nociception poses a multitude of challenges. First, sedated or unconscious patients by definition cannot experience pain. Under these circumstances, it is more accurate to assess the nociception level. A body of research suggests that not managing nociception can lead to central changes in pain pathways that predispose individuals to chronic pain states.

    Current "gold-standard" pain assessment tools rely on self-reporting, requiring an individual both to process external information and to communicate this personal experience.

    Circumstances exist where self-reporting is not possible, or where it is unreliable. In these situations, surrogate markers utilize changes in behavioral or physiological parameters. However, their use can be associated with considerable shortcomings. They may be unreliable, hampered by observational bias, or influenced by disease processes or pharmacological interventions. Developing an objective method of pain assessment therefore needs to ensure tools that are sensitive and specific to pain. They need to be observer-independent, not reliant on the patient's ability to communicate and not influenced by disease characteristics.

    A novel measure of nociception is the nociception level (NoL) index. It is based on objective measures related to changes in the autonomic nervous system. The NoL index ranges from 0 to 100 and is based on a nonlinear combination of nociception-related physiologic variables, specifically heart rate, heart rate variability at the 0.15- to 0.4-Hz band power, photoplethysmograph wave amplitude , skin conductance level, number of skin conductance fluctuations, and their time derivatives.

    In the trial the invastigator assume that combination of several parameters into a single one (Nol Index) may have a stronger association with pain intensity than each of the parameters alone.

    Medasense Biometrics Ltd. developed the PMD-200, a nociception/pain monitor that is based on a patented, non-invasive technology enabling objective, continuous assessment of changes in pain level. Information is collected through a finger-mounted probe that monitors changes in multiple pain-related physiological parameters (pulse rate, photoplethismograph amplitude, heart rate variability, skin conductance level and number of skin conductance fluctuations). This information is analyzed using proprietary artificial intelligence algorithms, which convert the physiological data to a real-time nociception Index.

    The rationale for developing the device is to provide caregivers with the ability to measure pain level (or nociception level for unconscious patients) during any procedure and at any time. This information can prevent unnecessary pain, avoid overdose or under usage of analgesic agents, enhance recovery and decrease hospitalization time and costs, while answering the critical need to supervise patients' pain/nociception level.

    The finger probe sensor of PMD-200 collects the following signals:

    1. PhotoPlethysmograph (PPG) - used to optically obtain a volumetric measurement of the finger's tip blood vessels. The trace is generated by light emitted from a LED (~780nm) and collected by a photo diode.
    2. Galvanic Skin Response (GSR) - used to measure the electrical conductance of the skin, which varies with its moisture level. The conductance is obtained by injecting a current between two electrodes placed on the finger and measuring the voltage.
    3. Temperature (TMP) - used to measure the skin temperature using a thermistor.
    4. Accelerometer (ACC) - used to measure finger movements The technology consists of measurements of a number of pain-related physiological parameters that corresponds with the autonomic nervous system's response to pain, and using the company's proprietary algorithms, 'translating' these measurements into an index that represents the pain response, the NoL™ (Nociception Level) Index. This index is displayed on a bedside monitor.

    The measurements taken by the Medasense monitor include galvanic skin response, photoplethysmography , skin temperature and movement .

    All measurements are taken simultaneously using a single finger probe attached to the patient's finger. Miniature sensors are embedded into the probe, which includes reusable and single use components. The finger probe is connected to the bedside monitor for processing of the data.

    Operating the PMD-200 monitor is similar to other standard-of-care systems that track changes in patients' vital functions, such as heart rate, blood pressure or blood oxygen saturation. Such monitors obtain their information from sensing element(s) attached to the patient, display the respective clinical values on a bedside, generate relevant alerts, and maintain records of the information tracked.

  2. Methods Population study - electively patients that are going to underwent laparoscopic cholecystectomy.

    1. First measurement will be taken a day before surgery by placing the device on a patient's 3rd finger for 3-5 minutes in a quiet environment. The measurement will be the NOL value (baseline) without pain. The patient will be asked to estimate the pain level using VAS (visual analog scale) score of 0-10.
    2. After determining the NOL value, an IV catheter will be inserted, as required pre-operatively.
    3. The device will continue measuring the pain level while the patient will be asked to estimate the pain level again using VAS .
    4. The patient will be operated.
    5. The patient will receive post-operative analgesia according to ward protocol - PRN IV Dipyrone 1g or PRN IV Paracetamol 1g.
    6. The device will measure pain from 5 minutes before until 20 minutes after analgesics administration. During this time VAS score will be taken. This measure will be taken up to 3 times during the post-operative hospitalization.
    7. The measurement will be taken in a quiet environment without distractions. Any distraction during measurement will be noted as an EVENT.

  3. Aims

    1. To examine the response of NoL Index in relation to pain
    2. To develop objective tool to assess the severity of pain in post-operative patient.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-100
  • Elective patient for laparoscopic cholecystectomy
  • Absence of acute or chronic pain

Exclusion Criteria:

  • Pregnancy
  • Dementia and mental retardation
  • Drugs that influence the autonomic system as beta blocker
  • Arrhythmia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pain level estimation by 1-100 scale by non invasive finger sensor
Time Frame: up to 7 months
a finger sensor will estimate the pain by a numerical scale of 1-100 in which 1 stand for no pain and 100 stand for severe pain.
up to 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Meir Hospital, Kfar Saba, Israel

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: haim Paran, MD, clalit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0054-17-MMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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