SurgeryNCT03276260
Evaluation of Medasense's PMD-200 During Surgery and Post Anesthesia Care
An observational study of Surgery and Nociceptive Pain, run by Medasense Biometrics Ltd at 1 site in Israel.
Trial summary
Medasense's Pain Monitoring Device (PMD) is a novel non-invasive, bedside stand alone, continuous monitor that is designed to provide real-time information about changes in the nociception level of patients under general anesthesia during surgical procedures. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Surgery, Nociceptive Pain, Postoperative Pain
- What is being tested?
- PMD-200
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2018to 30 Apr 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 100 patients scheduled for elective surgery under general, regional and local anesthesia and sedation, who meet all the inclusion and none of the exclusion criteria, will be enrolled after signing informed consent.
Who may be able to join
- Both genders
- Age 18 - 75 years
- ASA physical status 1-3
- Elective surgery
Who cannot join
- History of severe cardiac arrhythmia
- Abuse of alcohol or illicit drugs
- Preoperative opioid consumption for > 1 week
- History of mental retardation or any mental disease diagnosis
- Under sedation protocol - Patients with difficult spontaneous ventilation ( for e.g. patients with sleep apnea) will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Medasense's Pain Monitoring Device (PMD) is a novel non-invasive, bedside stand alone, continuous monitor that is designed to provide real-time information about changes in the nociception level of patients under general anesthesia during surgical procedures.
The PMD-200 System is based on real-time data acquisition and processing of physiological signals. The system displays the NOL index (a single numerical index) which is computed from recorded physiological parameters based on a proprietary algorithm.
Read the detailed description
The aim of this observational study is to evaluate the pattern of the NOL index during surgery in the anesthetized patient and during the post-operative period in the awake patient.
Up to 100 patients scheduled for elective surgery under general, regional and local anesthesia and sedation, who meet all the inclusion and none of the exclusion criteria, will be enrolled after signing informed consent.
- Conditions
- Surgery, Nociceptive Pain, Postoperative Pain
- Being tested
- PMD-200
- Medical subject headings
- Nociceptive Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMD-200Device
Patient will be connected to PMD-200 by finger-probe before induction of anesthesia or sedation. Recording will continue during surgery until extubation or awakening. Recording will be initiated again as soon as the patient arrives to the PACU until discharge to the surgical ward or home.
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability of NOL index to change in response to noxious and non noxious stimuli as well as in response to analgesic administration.
Measured: At time of surgery. 1 minute before and 1 minute after painful stimuli (for instance: intubation, skin incision, trocar insertion
Specificity and sensitivity of the NOL index for detecting nociception as evaluated by receiver operating characteristics curve (ROC) analysis.
The calculated area under the graph of change in NOL values in response to a painful stimulus, as mentioned in Outcome 1.
Measured: At time of surgery, between the anaesthesia induction and extubation.
Secondary outcomes (12)
The change in NOL Index in response to pre-defined non noxious and noxious stimuli during surgery in the anesthetized patient.
Pre-defined noxious events - laryngoscopy and intubation, skin incision or first trocar.
Measured: At time of surgery: pre-defined non noxious period - a period of 2 minutes with no noxious event with a minimal time period of 3 min prior and following laryngoscopy and intubation, skin incision or first trocar insertion.
The change in NOL index in response to administration of analgesics.
Measured: At time of surgery, 1min before versus 1 min after administration of analgesics drugs.
Total fentanyl administration during surgery and anaesthesia and frequency of bolus administration.
Measured: At time of surgery, between the anaesthesia induction and extubation.
Total time with mean arterial pressure (MAP) < 65 mmHg and correlation to NOL values during surgery and anaesthesia.
Measured: At time of surgery, between the anaesthesia induction and extubation.
Total analgesics administration during PACU (arrival to discharge) and frequency of administration
Measured: Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
NOL values during stay in PACU in the awake patient (arrival to discharge)
The NOL will be calculated via the investigational device.
Measured: Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
Patients' NRS (numerical rating scale ) values during stay in PACU (arrival to discharge).
NRS will be recorded every 15 min in the PACU
Measured: Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
Sedation scores during stay in PACU (arrival to discharge).
Sedation scores will be recorded every 30 min in the PACU
Measured: Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
Time to first analgesic request or administration in PACU.
Measured: Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
Number of opioid adverse effects in PACU (nausea and vomiting, pruritus, desaturation, respiratory depression, apnea).
Measured: Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
Time of readiness to discharge from PACU
This time will be recorded since it may be different from the actual time of discharge which may be prolonged due to non-medical reasons.
Measured: Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
The correlation between NOL values during surgery and anesthesia to NOL values during the post-operative period.
The NOL will be calculated via the investigational device.
Measured: From the anaesthesia induction till the discharge from the PACU, an average of 5-6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start1 Jan 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Why it stopped: PI decided not to continue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medasense Biometrics Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruth Edry, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276260
- Sponsor's protocol ID
- CLI-17-02
- Status last verified
- Mar 2020
- First submitted
- 2 Aug 2017
- Last updated
- 11 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Edry R, Recea V, Dikust Y, Sessler DI. Preliminary Intraoperative Validation of the Nociception Level Index: A Noninvasive Nociception Monitor. Anesthesiology. 2016 Jul;125(1):193-203. doi: 10.1097/ALN.0000000000001130.
PubMed 27171828Martini CH, Boon M, Broens SJ, Hekkelman EF, Oudhoff LA, Buddeke AW, Dahan A. Ability of the nociception level, a multiparameter composite of autonomic signals, to detect noxious stimuli during propofol-remifentanil anesthesia. Anesthesiology. 2015 Sep;123(3):524-34. doi: 10.1097/ALN.0000000000000757.
PubMed 26154185Treister R, Kliger M, Zuckerman G, Aryeh IG, Eisenberg E. Differentiating between heat pain intensities: the combined effect of multiple autonomic parameters. Pain. 2012 Sep;153(9):1807-1814. doi: 10.1016/j.pain.2012.04.008. Epub 2012 May 29.
PubMed 22647429Ben-Israel N, Kliger M, Zuckerman G, Katz Y, Edry R. Monitoring the nociception level: a multi-parameter approach. J Clin Monit Comput. 2013 Dec;27(6):659-68. doi: 10.1007/s10877-013-9487-9. Epub 2013 Jul 9.
PubMed 23835792
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Medasense's PMD-200 During Surgery and Post Anesthesia Care
- ClinicalTrials.gov ID
- NCT03276260
- Acronym / sponsor ID
- CLI-17-02
- Conditions
- Surgery, Nociceptive Pain, Postoperative Pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI decided not to continue
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Medasense Biometrics LtdUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 8 Sep 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.
Medasense's Pain Monitoring Device (PMD) is a novel non-invasive, bedside stand alone, continuous monitor that is designed to provide real-time information about changes in the nociception level of patients under general anesthesia during surgical procedures.
The PMD-200 System is based on real-time data acquisition and processing of physiological signals. The system displays the NOL index (a single numerical index) which is computed from recorded physiological parameters based on a proprietary algorithm.
Detailed description
The aim of this observational study is to evaluate the pattern of the NOL index during surgery in the anesthetized patient and during the post-operative period in the awake patient.
Up to 100 patients scheduled for elective surgery under general, regional and local anesthesia and sedation, who meet all the inclusion and none of the exclusion criteria, will be enrolled after signing informed consent.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 100 patients scheduled for elective surgery under general, regional and local anesthesia and sedation, who meet all the inclusion and none of the exclusion criteria, will be enrolled after signing informed consent.
Key inclusion criteria (4 listed)
- Both genders
- Age 18 - 75 years
- ASA physical status 1-3
- Elective surgery
Key exclusion criteria (5 listed)
- History of severe cardiac arrhythmia
- Abuse of alcohol or illicit drugs
- Preoperative opioid consumption for > 1 week
- History of mental retardation or any mental disease diagnosis
- Under sedation protocol - Patients with difficult spontaneous ventilation ( for e.g. patients with sleep apnea) will be excluded.
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-200Patient will be connected to PMD-200 by finger-probe before induction of anesthesia or sedation. Recording will continue during surgery until extubation or awakening. Recording will be initiated again as soon as the patient arrives to the PACU until discharge to the surgical ward or home. | Device | – |
Primary outcome
The ability of NOL index to change in response to noxious and non noxious stimuli as well as in response to analgesic administration.
Time frame: At time of surgery. 1 minute before and 1 minute after painful stimuli (for instance: intubation, skin incision, trocar insertion
Specificity and sensitivity of the NOL index for detecting nociception as evaluated by receiver operating characteristics curve (ROC) analysis.
Time frame: At time of surgery, between the anaesthesia induction and extubation.
The calculated area under the graph of change in NOL values in response to a painful stimulus, as mentioned in Outcome 1.
12 secondary outcomes
The change in NOL Index in response to pre-defined non noxious and noxious stimuli during surgery in the anesthetized patient.
Time frame: At time of surgery: pre-defined non noxious period - a period of 2 minutes with no noxious event with a minimal time period of 3 min prior and following laryngoscopy and intubation, skin incision or first trocar insertion.
The change in NOL index in response to administration of analgesics.
Time frame: At time of surgery, 1min before versus 1 min after administration of analgesics drugs.
Total fentanyl administration during surgery and anaesthesia and frequency of bolus administration.
Time frame: At time of surgery, between the anaesthesia induction and extubation.
Total time with mean arterial pressure (MAP) < 65 mmHg and correlation to NOL values during surgery and anaesthesia.
Time frame: At time of surgery, between the anaesthesia induction and extubation.
Total analgesics administration during PACU (arrival to discharge) and frequency of administration
Time frame: Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
NOL values during stay in PACU in the awake patient (arrival to discharge)
Time frame: Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
Patients' NRS (numerical rating scale ) values during stay in PACU (arrival to discharge).
Time frame: Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
Sedation scores during stay in PACU (arrival to discharge).
Time frame: Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
Time to first analgesic request or administration in PACU.
Time frame: Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
Number of opioid adverse effects in PACU (nausea and vomiting, pruritus, desaturation, respiratory depression, apnea).
Time frame: Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
Time of readiness to discharge from PACU
Time frame: Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
The correlation between NOL values during surgery and anesthesia to NOL values during the post-operative period.
Time frame: From the anaesthesia induction till the discharge from the PACU, an average of 5-6 hours.
Results and safety
The study was stopped early (reason given: PI decided not to continue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Background: PubMed 27171828Edry R, Recea V, Dikust Y, Sessler DI. Preliminary Intraoperative Validation of the Nociception Level Index: A Noninvasive Nociception Monitor. Anesthesiology. 2016 Jul;125(1):193-203. doi: 10.1097/ALN.0000000000001130.
- Background: PubMed 26154185Martini CH, Boon M, Broens SJ, Hekkelman EF, Oudhoff LA, Buddeke AW, Dahan A. Ability of the nociception level, a multiparameter composite of autonomic signals, to detect noxious stimuli during propofol-remifentanil anesthesia. Anesthesiology. 2015 Sep;123(3):524-34. doi: 10.1097/ALN.0000000000000757.
- Background: PubMed 22647429Treister R, Kliger M, Zuckerman G, Aryeh IG, Eisenberg E. Differentiating between heat pain intensities: the combined effect of multiple autonomic parameters. Pain. 2012 Sep;153(9):1807-1814. doi: 10.1016/j.pain.2012.04.008. Epub 2012 May 29.
- Background: PubMed 23835792Ben-Israel N, Kliger M, Zuckerman G, Katz Y, Edry R. Monitoring the nociception level: a multi-parameter approach. J Clin Monit Comput. 2013 Dec;27(6):659-68. doi: 10.1007/s10877-013-9487-9. Epub 2013 Jul 9.
- 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.
Ruth Edry, MD principal investigator
Rambam Health Care Campus
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 Surgery and Nociceptive Pain, 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 5 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 11 Mar 2020. 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: PI decided not to continue). 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?
The ability of NOL index to change in response to noxious and non noxious stimuli as well as in response to analgesic administration. (time frame: At time of surgery. 1 minute before and 1 minute after painful stimuli (for instance: intubation, skin incision, trocar insertion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03276260, which also lists 4 linked publications.
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 11 Mar 2020.