Aortic Valve ReplacementEPIKARDNCT03889288
Innovative Device for Pain Management by Millimeter Band Radiation: Electronic-Pain Killer
A study testing Medical device - electronic-pain killer in people with Aortic Valve Replacement, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The objective of this study is to evaluate a new medical device in the management of pain. The principle of this new treatment is based on the emission of electromagnetic radiation in millimeter band. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Replacement
- What is being tested?
- Medical device - electronic-pain killer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2019to Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- candidate for an aortic valve replacement with extra-corporal flow.
- wrist size between 14.5 and 18.5 centimeters (for the experimental group)
- patient affiliated to social security
- signature of the informed consent (for the experimental group)
Who cannot join
- patient with diabetes
- patient with an evolutive cancer
- patient with cardiac assistance
- patient under the influence of opioid in the 48 hours before the surgery
- patient deprived of liberty by judicial or administrative decision
- patient subject to legal protection or unable to express his consent (guardianship or curators)
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- patient with diabetes
- patient with an evolutive cancer
- patient with surgery planning within 48 hours
- patient with cardiac assistance
- patient under the influence of opioid in the 48 hours before the surgery
- patient suffering from a dermatological disease such as oozing dermatitis, hyper sweating, or an unhealed lesion in the wrists.
- patient who has a piercing in the wrist or another metal material
- patient known for having a multi-resistant bacterial strain
- protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Grenoble Alpes University Hospital
Grenoble, 38043
Pierre Albaladejo, MD, PhD
Caroline Maindet, MD
About this study
Official title: Innovative Device for Pain Management by Millimeter Band Radiation: Electronic-Pain Killer: First in Human Evaluation in Perioperative With Regard to a Control Group
The objective of this study is to evaluate a new medical device in the management of pain. The principle of this new treatment is based on the emission of electromagnetic radiation in millimeter band. This new modality of pain management is evaluated in a perioperative management in patients undergoing surgery for aortic valve replacement.
The hypothesis is that the use of this medical device in perioperative would reduce the consumption of postoperative morphine with an identical quality of analgesia. The decline in morphine consumption would allow a decrease in opioid adverse effects.
- Conditions
- Aortic Valve Replacement
- Being tested
- Medical device - electronic-pain killer
- Keywords
- pain treatment, intensive care, cardiology, medical device
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical device - electronic-pain killerDevice
Treatment sessions with the medical device (no-marked EC): 2 sessions before surgery and 4 or 5 sessions until 48 hours after surgery. Each treatment sessions takes 45 minutes. Each session is spaced by 12 +/-3 hours.
| Study group | Role | What they receive |
|---|---|---|
| conventional management of postoperative pain | No intervention | Patients who have had an aortic valve replacement surgery have a conventional management of pain after surgery. The pain is treated by morphine using a patient-controlled analgesia for the administration. Patients are recruiting prospectively or possibly retrospectively. The management is usual, nothing from the conventional care of patients change, only data will be collected. |
| Medical device - electronic-pain killer | Experimental | In addition to the conventional management of postoperative pain, patients benefit from perioperative treatment sessions with medical device. Patients are recruiting prospectively. Receives: Device: Medical device - electronic-pain killer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative consumption of morphine auto-administered in the experimental group in the first 48 hours : descriptive analysis
The morphine cumulative consumption administered by auto-analgesia in the experimental group at 24 and 48 hours after the surgery
Measured: 48 hours
Secondary outcomes (14)
Cumulative consumption of morphine auto-administered in the control group in the first 48 hours : descriptive analysis
The morphine cumulative consumption administered by auto-analgesia in the control group at 24 and 48 hours after the surgery
Measured: 48 hours
Determine the number of patients required to demonstrate a 30% decrease in morphine consumption within the first 48h following aortic valve replacement surgery in a population treated with "Electronic-Pain-Killer" compared to conventional pain management
Cumulative morphine consumption in milligrams, administered by auto-analgesia, at 48 hours post-operatively in the experimental and control groups.
Measured: 48 hours
Troponin's peak characterization in the first 48 hours postoperatively.
The troponin is assessed in ng/ml in the two groups from the end of the surgery until 48 hours postoperatively
Measured: 48 hours
The Pain characterization: Echelle Numérique Standard; standard digital scale
The patient pain is evaluated using the ENS (Echelle Numérique Standard; standard digital scale, score between 0 to 10) for both groups.
Measured: 48 hours
The hospitalization length in the intensive care unit
For the two groups, the hospitalization length in the intensive care unit is assessed in hours.
Measured: 48 hours
Characterization of analgesic drugs
The analgesic drugs are characterized by their class, dose and number of dose taken in the two groups since they are in the intensive care unit.
Measured: 48 hours
Number of postoperative nausea or vomiting events (number of PONV) in the experimental group
In the experimental group, the number of PONV events requiring a treatment is assessed.
Measured: 48 hours
Delirium events in the experimental group
The number of delirium events is assessed using the CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) scale in the experimental group.
Measured: 48 hours
Adverse effect from the medical device
The number of adverse effects from the medical device is assessed from the first session with the medical device to the follow-up visit.
Measured: 48 hours
Description of the medical device use
Log files of the medical device are extracted. The length of each session, the start and end session times, each stopping is analysed.
Measured: 48 hours
Medical device acceptability : score
This score has been specifically created for the electronic pain killer medical device. Each item range from 0 (the worst) to 10 (the best).
Measured: 48 hours
Medical device acceptability : descriptive analysis
Open questions will be asked in a questionnaire without scale. A descriptive analysis will be done with the answers.
Measured: 48 hours
Use Error evaluation : System Usability Scale (SUS)
The System Usability Scale (SUS) contains 10 questions that are rated on a scale from 1 to 5. "The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100." Jeff Sauro established the average score of SUS is 68.
The score can go from 0 (worst) to 100 (best).
Measured: 48 hours
Subgroup analysis excluding patients who have had Nefopam administration
To avoid a potential bias confusion, patients taking Nefopam drug are excluded from the analyses and all the previous outcome are assessed again.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start16 Jun 2019
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve ReplacementStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Remedee SA, Clinical Investigation Centre for Innovative Technology Network
- Responsible party
- Sponsor
- Investigators
- Pierre Albaladejo, MD, PhD, Principal investigator, Grenoble Alpes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889288
- Sponsor's protocol ID
- 38RC18.170
- Acronym
- EPIKARD
- Status last verified
- Feb 2021
- First submitted
- 19 Mar 2019
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Device for Pain Management by Millimeter Band Radiation: Electronic-Pain Killer: First in Human Evaluation in Perioperative With Regard to a Control Group
- ClinicalTrials.gov ID
- NCT03889288
- Acronym / sponsor ID
- EPIKARD / 38RC18.170
- Conditions
- Aortic Valve Replacement
- Keywords
- pain treatment, intensive care, cardiology, medical device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Remedee SA, Clinical Investigation Centre for Innovative Technology Network
- Study start
- 16 Jun 2019 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 26 Mar 2019 (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 objective of this study is to evaluate a new medical device in the management of pain. The principle of this new treatment is based on the emission of electromagnetic radiation in millimeter band. This new modality of pain management is evaluated in a perioperative management in patients undergoing surgery for aortic valve replacement.
The hypothesis is that the use of this medical device in perioperative would reduce the consumption of postoperative morphine with an identical quality of analgesia. The decline in morphine consumption would allow a decrease in opioid adverse effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional management of postoperative pain | No intervention | –Patients who have had an aortic valve replacement surgery have a conventional management of pain after surgery. The pain is treated by morphine using a patient-controlled analgesia for the administration. Patients are recruiting prospectively or possibly retrospectively. The management is usual, nothing from the conventional care of patients change, only data will be collected. |
| Medical device - electronic-pain killer | Experimental | Device: Medical device - electronic-pain killerIn addition to the conventional management of postoperative pain, patients benefit from perioperative treatment sessions with medical device. Patients are recruiting prospectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- candidate for an aortic valve replacement with extra-corporal flow.
- wrist size between 14.5 and 18.5 centimeters (for the experimental group)
- patient affiliated to social security
- signature of the informed consent (for the experimental group)
Key exclusion criteria (15 listed)
- patient with diabetes
- patient with an evolutive cancer
- patient with cardiac assistance
- patient under the influence of opioid in the 48 hours before the surgery
- patient deprived of liberty by judicial or administrative decision
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 |
|---|---|---|
| Medical device - electronic-pain killerTreatment sessions with the medical device (no-marked EC): 2 sessions before surgery and 4 or 5 sessions until 48 hours after surgery. Each treatment sessions takes 45 minutes. Each session is spaced by 12 +/-3 hours. | Device | Medical device - electronic-pain killer |
Primary outcome
Cumulative consumption of morphine auto-administered in the experimental group in the first 48 hours : descriptive analysis
Time frame: 48 hours
The morphine cumulative consumption administered by auto-analgesia in the experimental group at 24 and 48 hours after the surgery
14 secondary outcomes
Cumulative consumption of morphine auto-administered in the control group in the first 48 hours : descriptive analysis
Time frame: 48 hours
Determine the number of patients required to demonstrate a 30% decrease in morphine consumption within the first 48h following aortic valve replacement surgery in a population treated with "Electronic-Pain-Killer" compared to conventional pain management
Time frame: 48 hours
Troponin's peak characterization in the first 48 hours postoperatively.
Time frame: 48 hours
The Pain characterization: Echelle Numérique Standard; standard digital scale
Time frame: 48 hours
The hospitalization length in the intensive care unit
Time frame: 48 hours
Characterization of analgesic drugs
Time frame: 48 hours
Number of postoperative nausea or vomiting events (number of PONV) in the experimental group
Time frame: 48 hours
Delirium events in the experimental group
Time frame: 48 hours
Adverse effect from the medical device
Time frame: 48 hours
Description of the medical device use
Time frame: 48 hours
Medical device acceptability : score
Time frame: 48 hours
Medical device acceptability : descriptive analysis
Time frame: 48 hours
Use Error evaluation : System Usability Scale (SUS)
Time frame: 48 hours
Subgroup analysis excluding patients who have had Nefopam administration
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 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.
Pierre Albaladejo, MD, PhD principal investigator
Grenoble Alpes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical device - electronic-pain killer in people with Aortic Valve Replacement, run by University Hospital, Grenoble at 1 site in France.
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 15 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 2 Mar 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Albaladejo, MD, PhD (+33 4 76 76 92 88, palbaladejo@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative consumption of morphine auto-administered in the experimental group in the first 48 hours : descriptive analysis (time frame: 48 hours). 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 2 Mar 2021.