AnesthesiaNCT03466138
Performance Assessment of the PMD-200 in Subjects Requiring Surgery Under General Anesthesia
An observational study of Anesthesia, run by Medasense Biometrics Ltd at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- PMD-200
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 13 Dec 2016to 1 Dec 2020
- Phase
- Observational
- 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
- Adult, Older adult
Study population: The study population includes subjects requiring a surgical procedure under general anesthesia.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance Assessment of the Physiological Monitoring Device - PMD-200 - in Subjects Requiring Surgery Under General Anesthesia
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.
Read the detailed description
The proposed study is designed to further demonstrate the performance of the NoL Index in surgical patient under general anesthesia, by evaluating its response to controlled changes in the levels of noxious stimuli/analgesia mentioned characteristics 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.
In this study the investigators plan to demonstrate that the NoL Index is a continuous index. It is anticipated that a higher level of nociception will correspond to a higher NoL index. On the other hand, it is anticipated that higher levels of analgesic agent for the same noxious stimulus will lead to a lower NoL index. This will be achieved by measuring the NoL response to various types of noxious stimuli, varying in their intensities, under different levels of analgesic agents.
The noxious stimuli that will be used in this pivotal study are:
- - Intubation
- - Incision and/or trocar insertion
- - Internal handling during the surgical procedure
- - Extubation
- - Other specific pain event related to the surgical procedure (e.g. bone related treatment in orthopedic, muscle tension or cut etc.).
The study population includes subjects requiring a surgical procedure under general anesthesia. During the surgical procedure the subject is anesthetized (by various anesthetic agents) and paralyzed (by muscle relaxant agents). Thus, the response to noxious stimuli under those conditions will be related to the underlying physiological response. The participants will be monitored, as in a typical surgery and according to the local guidelines, by various types of monitoring devices, such as: vital signs, pulse oximeter, Bispectral Index (BIS), Electroencephalography (EEG) etc. Therefore, patients suffering from fluctuations in their vital signs and hemodynamic parameters during the surgical procedure, can be detected by the various monitors. However, assessment of the level of nociception is still complex, subjective and mainly depends on the physician's experience and knowledge.
Development of a nociception monitor that may present an index to assess the level of nociception will allow the anesthesiologist better patient management during the surgical procedure.
- Conditions
- Anesthesia
- Being tested
- PMD-200
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMD-200Device
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)
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | subjects requiring a surgical procedure under general anesthesia. monitored by PMD-200 Receives: Device: PMD-200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The NoL values can be correlate to other nociception predictors (e.g heart rate, blood pressure) following a noxious stimuli
Measured: Through study completion, about one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start13 Dec 2016
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medasense Biometrics Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tibi Ezri, Prof., Principal investigator, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466138
- Sponsor's protocol ID
- CLI-16-02
- Status last verified
- Apr 2021
- First submitted
- 27 Dec 2017
- Last updated
- 4 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Assessment of the Physiological Monitoring Device - PMD-200 - in Subjects Requiring Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT03466138
- Acronym / sponsor ID
- CLI-16-02
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medasense Biometrics LtdUniversity, hospital or other
- Study start
- 13 Dec 2016 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 15 Mar 2018 (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 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.
Detailed description
The proposed study is designed to further demonstrate the performance of the NoL Index in surgical patient under general anesthesia, by evaluating its response to controlled changes in the levels of noxious stimuli/analgesia mentioned characteristics 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.
In this study the investigators plan to demonstrate that the NoL Index is a continuous index. It is anticipated that a higher level of nociception will correspond to a higher NoL index. On the other hand, it is anticipated that higher levels of analgesic agent for the same noxious stimulus will lead to a lower NoL index. This will be achieved by measuring the NoL response to various types of noxious stimuli, varying in their intensities, under different levels of analgesic agents.
The noxious stimuli that will be used in this pivotal study are:
- - Intubation
- - Incision and/or trocar insertion
- - Internal handling during the surgical procedure
- - Extubation
- - Other specific pain event related to the surgical procedure (e.g. bone related treatment in orthopedic, muscle tension or cut etc.).
The study population includes subjects requiring a surgical procedure under general anesthesia. During the surgical procedure the subject is anesthetized (by various anesthetic agents) and paralyzed (by muscle relaxant agents). Thus, the response to noxious stimuli under those conditions will be related to the underlying physiological response. The participants will be monitored, as in a typical surgery and according to the local guidelines, by various types of monitoring devices, such as: vital signs, pulse oximeter, Bispectral Index (BIS), Electroencephalography (EEG) etc. Therefore, patients suffering from fluctuations in their vital signs and hemodynamic parameters during the surgical procedure, can be detected by the various monitors. However, assessment of the level of nociception is still complex, subjective and mainly depends on the physician's experience and knowledge.
Development of a nociception monitor that may present an index to assess the level of nociception will allow the anesthesiologist better patient management during the surgical procedure.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | – | Device: PMD-200subjects requiring a surgical procedure under general anesthesia. monitored by PMD-200 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population includes subjects requiring a surgical procedure under general anesthesia.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
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-200The 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) | Device | General Anesthesia |
Primary outcome
demonstrate the NoL Index correlation prior and following a noxious stimuli.
Time frame: Through study completion, about one year
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.
1 secondary outcome
Correlation between the NoL Index and other nociception predictors (such as heart rate - Beats per Minute) following a noxious stimuli.
Time frame: Through study completion, about one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
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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.
Tibi Ezri, Prof. principal investigator
Wolfson Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Medasense Biometrics Ltd at 1 site in 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
demonstrate the NoL Index correlation prior and following a noxious stimuli. (time frame: Through study completion, about one year). 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 4 May 2021.