Pain, PostoperativeNCT03252301
Assessment of Pain in Surgical Patient by PMD 200
A study testing PMD 200 in people with Pain, Postoperative, run by Meir Hospital, Kfar Saba, Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- PMD 200
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-100
- Elective patient for laparoscopic cholecystectomy
- Absence of acute or chronic pain
Who cannot join
- Pregnancy
- Dementia and mental retardation
- Drugs that influence the autonomic system as beta blocker
- Arrhythmia
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
- 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:
- 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.
- 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.
- Temperature (TMP) - used to measure the skin temperature using a thermistor.
- 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.
- Methods Population study - electively patients that are going to underwent laparoscopic cholecystectomy.
- 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.
- After determining the NOL value, an IV catheter will be inserted, as required pre-operatively.
- The device will continue measuring the pain level while the patient will be asked to estimate the pain level again using VAS .
- The patient will be operated.
- The patient will receive post-operative analgesia according to ward protocol - PRN IV Dipyrone 1g or PRN IV Paracetamol 1g.
- 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.
- The measurement will be taken in a quiet environment without distractions. Any distraction during measurement will be noted as an EVENT.
- Aims
- To examine the response of NoL Index in relation to pain
- To develop objective tool to assess the severity of pain in post-operative patient.
- Conditions
- Pain, Postoperative
- Being tested
- PMD 200
- Keywords
- pain, post operative, surgery, objective
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMD 200Device
finger sensor which estimate objectively the pain level
What is being measured
The primary outcome is the main question the study is designed to answer.
pain level estimation by 1-100 scale by non invasive finger sensor
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.
Measured: up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start1 Sep 2017 (estimated)
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Hospital, Kfar Saba, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guy Elad, Meir Hospital, Kfar Saba, Israel
- Investigators
- haim Paran, MD, Study chair, clalit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252301
- Sponsor's protocol ID
- 0054-17-MMC
- Status last verified
- Aug 2017
- First submitted
- 11 Aug 2017
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pain in Surgical Patient by PMD 200
- ClinicalTrials.gov ID
- NCT03252301
- Acronym / sponsor ID
- 0054-17-MMC
- Conditions
- Pain, Postoperative
- Keywords
- pain, post operative, surgery, objective
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Meir Hospital, Kfar Saba, IsraelUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 17 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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:
- 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.
- 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.
- Temperature (TMP) - used to measure the skin temperature using a thermistor.
- 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.
- Methods Population study - electively patients that are going to underwent laparoscopic cholecystectomy.
- 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.
- After determining the NOL value, an IV catheter will be inserted, as required pre-operatively.
- The device will continue measuring the pain level while the patient will be asked to estimate the pain level again using VAS .
- The patient will be operated.
- The patient will receive post-operative analgesia according to ward protocol - PRN IV Dipyrone 1g or PRN IV Paracetamol 1g.
- 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.
- The measurement will be taken in a quiet environment without distractions. Any distraction during measurement will be noted as an EVENT.
- Aims
- To examine the response of NoL Index in relation to pain
- To develop objective tool to assess the severity of pain in post-operative patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-100
- Elective patient for laparoscopic cholecystectomy
- Absence of acute or chronic pain
Key exclusion criteria (4 listed)
- Pregnancy
- Dementia and mental retardation
- Drugs that influence the autonomic system as beta blocker
- Arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PMD 200finger sensor which estimate objectively the pain level | Device | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
haim Paran, MD study chair
clalit
Questions about this trial
What is this clinical trial studying?
A study testing PMD 200 in people with Pain, Postoperative, run by Meir Hospital, Kfar Saba, Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guy Elad, MD (972543977953, dr.guyelad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain level estimation by 1-100 scale by non invasive finger sensor (time frame: up to 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2017.