Anesthesia, GeneralNCT03452163
Performance Assessment of the PMD-200 in Subjects at Neurointensive Care Unit
A study testing PMD-200 and EEG monitor in people with Anesthesia, General, run by Medasense Biometrics Ltd at 1 site in Israel.
Trial summary
Performance Assessment of the PMD-200, a Novel Pain Monitor, in Subjects at Neurointensive Care Unit. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- PMD-200 and EEG monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Mar 2018to 30 Nov 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old.
- The subject is under general anesthesia
- The subject have a blood pressure measurement (either arterial or cuff) during the study
- A signed Informed Consent Form (ICF) has been obtain
Who cannot join
- The subject is constantly agitate or moving a lot
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance Assessment of the Physiological Monitor Device (PMD-200), a Novel Pain Monitor, in Subjects at Neurointensive Care Unit (NICU).
Performance Assessment of the PMD-200, a Novel Pain Monitor, in Subjects at Neurointensive Care Unit.
Read the detailed description
The proposed study is design to further demonstrates the performance of the Nociception Level (NoL) Index in neurological impaired anesthetized patients under general anesthesia, by evaluating its response to controlled changes in the levels of noxious stimuli/analgesia, and to correlate the NoL response to the EEG derived pain score. Validating the performance of the NoL Index may provide a tool to monitor the pain/nociception in this population.
In this study, the PI 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.
The participants will be monitored as in a typical ICU and according to the local guidelines by various types of monitoring devices, such as: vital signs, pulse oximeter, Bispectral Index (BIS), Electroencephalography (EEG) etc.
- Conditions
- Anesthesia, General
- Being tested
- PMD-200, EEG monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMD-200Device
the patients will be monitored by PMD-200. The technology consists of measurements of a number of nociception-related physiological parameters that corresponds with the autonomic nervous system's response to noxious stimuli, and using the company's proprietary algorithms, 'translating' these measurements into an index that represents the nociceptive response, the NoL™ (Nociception Level) Index. The NoL index is a relative index from 0 to 100, while 0 is "no pain/nociception" and 100 is "extreme pain/nociception".
EEG monitorDevice
An EEG device will be connected to the patient and display the Spectral Edge Frequency (SEF) signals and values on the subject monitor.
| Study group | Role | What they receive |
|---|---|---|
| Anesthesia, General | Experimental | Subjects under anesthesia that are expected to stay for at least 24 hours in the ICU/NICU will be monitored by the PMD-200 device. An EEG monitor device will be connected to the patient and display the Spectral Edge Frequency (SEF) signals and values on the subject monitor. Receives: Device: PMD-200; Device: EEG monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between changes in the nociception levels of the subject (NoL Index value) prior and following a noxious stimuli
To demonstrate that the NoL Index is correlates with changes in the nociception levels of the subject prior and following a noxious stimuli.
Measured: Through study completion, about one year
Secondary outcomes (2)
Correlation between changes in the nociception levels of the subject (NoL Index value) to other nociception predictors (HR, NIBP)
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
Correlation between the NoL index and the EEG derived pain score
To assess the correlation between the NoL index and the EEG derived pain score during arousal response caused by 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 posted2 Mar 2018
- Study start8 Mar 2018
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Why it stopped: Inability to support study performance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medasense Biometrics Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Soustiel, Prof., Principal investigator, Dept. of Neurosurgery Galilee Medical Center, Nahariya, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452163
- Sponsor's protocol ID
- CLI-16-03
- Status last verified
- Mar 2020
- First submitted
- 21 Jan 2018
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Assessment of the Physiological Monitor Device (PMD-200), a Novel Pain Monitor, in Subjects at Neurointensive Care Unit (NICU).
- ClinicalTrials.gov ID
- NCT03452163
- Acronym / sponsor ID
- CLI-16-03
- Conditions
- Anesthesia, General
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to support study performance
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Medasense Biometrics LtdUniversity, hospital or other
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 2 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.
Performance Assessment of the PMD-200, a Novel Pain Monitor, in Subjects at Neurointensive Care Unit.
Detailed description
The proposed study is design to further demonstrates the performance of the Nociception Level (NoL) Index in neurological impaired anesthetized patients under general anesthesia, by evaluating its response to controlled changes in the levels of noxious stimuli/analgesia, and to correlate the NoL response to the EEG derived pain score. Validating the performance of the NoL Index may provide a tool to monitor the pain/nociception in this population.
In this study, the PI 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.
The participants will be monitored as in a typical ICU and according to the local guidelines by various types of monitoring devices, such as: vital signs, pulse oximeter, Bispectral Index (BIS), Electroencephalography (EEG) etc.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anesthesia, General | Experimental | Device: PMD-200, Device: EEG monitorSubjects under anesthesia that are expected to stay for at least 24 hours in the ICU/NICU will be monitored by the PMD-200 device. An EEG monitor device will be connected to the patient and display the Spectral Edge Frequency (SEF) signals and values on the subject monitor. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years old.
- The subject is under general anesthesia
- The subject have a blood pressure measurement (either arterial or cuff) during the study
- A signed Informed Consent Form (ICF) has been obtain
Key exclusion criteria (1 listed)
- The subject is constantly agitate or moving a lot
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 patients will be monitored by PMD-200. The technology consists of measurements of a number of nociception-related physiological parameters that corresponds with the autonomic nervous system's response to noxious stimuli, and using the company's proprietary algorithms, 'translating' these measurements into an index that represents the nociceptive response, the NoL™ (Nociception Level) Index. The NoL index is a relative index from 0 to 100, while 0 is "no pain/nociception" and 100 is "extreme pain/nociception". | Device | Anesthesia, General |
| EEG monitorAn EEG device will be connected to the patient and display the Spectral Edge Frequency (SEF) signals and values on the subject monitor. | Device | Anesthesia, General |
Primary outcome
Correlation between changes in the nociception levels of the subject (NoL Index value) prior and following a noxious stimuli
Time frame: Through study completion, about one year
To demonstrate that the NoL Index is correlates with changes in the nociception levels of the subject prior and following a noxious stimuli.
2 secondary outcomes
Correlation between changes in the nociception levels of the subject (NoL Index value) to other nociception predictors (HR, NIBP)
Time frame: Through study completion, about one year
Correlation between the NoL index and the EEG derived pain score
Time frame: Through study completion, about one year
Results and safety
The study was stopped early (reason given: Inability to support study performance). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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.
Jean Soustiel, Prof. principal investigator
Dept. of Neurosurgery Galilee Medical Center, Nahariya, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PMD-200 and EEG monitor in people with Anesthesia, General, 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 1 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: stopped early, as of the sponsor's last update on 6 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 was stopped early (reason given: Inability to support study performance). Results are not available in the source record.
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?
Correlation between changes in the nociception levels of the subject (NoL Index value) 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 6 May 2021.