ConfusionHYPSEDNCT03974269
Hypnosis Versus SIVOC by Remifentanil During TAVI Procedures : Iloact on Peripoperative Confusion
A study testing TAVI : Transcatether Aortic Valve Implantation in people with Confusion, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
Trial summary
TAVI has become a credible alternative to conventional cardiac surgery in aged high-risk patients with aortic valve stenosis. A large part of these procedures are performed with sedation using remifentanil target-controlled infusion plus local anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Confusion
- What is being tested?
- TAVI : Transcatether Aortic Valve Implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2018to 11 Jun 2021
- 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
- Patients requiring transfemoral approach TAVI without general anesthesia
- For adult patients : age greater than or equal to 18 years
- Patients affiliated to a social security scheme
Who cannot join
- Patient whose age is less than 18 years
- Approach with general anesthesia
- Patient not responding to Hypnosis: unmotivated, non-cooperating, not confident
- Other than transfemoral approach : carotid, trans-apical or sternotomy or thoracotomy procedure
- chronic psychosis, bilateral deafness without hearing aids,
- emergency procedure,
- inability to communicate (severe dementia, non-French speaker),
- declined participation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Marie Lannelongue
Le Plessis-Robinson, 92350
Marina Rubatti, 0033140948635, m.rubatti@hml.fr
Carmen Credico, 0033140948624, c.credico@hml.fr
About this study
Official title: Hypnosis Versus Intravenous Sedation With Concentration Objective (SIVOC) by Remifentanil During TAVI Procedures: Impact on Perioperative Confusion
TAVI has become a credible alternative to conventional cardiac surgery in aged high-risk patients with aortic valve stenosis. A large part of these procedures are performed with sedation using remifentanil target-controlled infusion plus local anesthesia. However, a significant proportion of the patients experience postoperative delirium, with subsequent worsened outcomes, time-consuming interventions, and increased costs. The use of hypnosis before and during TAVI could decrease the incidence of postoperative delirium thanks to less opioids and hypnotics consumption. Thus, the investigators ought to evaluate the potential advantages of hypnosis vs. remifentanil target controlled-infusion during TAVI procedures.
Read the detailed description
Each included patient will randomly be assigned either to the hypnosis group or to the remifentanil group. Patients of the hypnosis group will have one preoperative and one perioperative hypnosis session with a qualified anesthesiologist. Patients of the remifentanil group will receive sedation with remifentanil, administered using a pre specified target controlled-infusion protocol.
Incidence of delirium will be recorded in the cardiac intensive care unit (CICU) during the first 72 postoperative hours, using the Confusion Assessment Method in the ICU (CAM-ICU). Incidence of other complications such as episodes of oxygen desaturation, vascular wound, stroke, general anesthesia requirement and inhospital death will be recorded, as well as procedure duration, hospital length of stay, patient satisfaction and operator comfort.
Transcatheter aortic valve implantation (TAVI) procedures are frequently complicated with postoperative delirium.
- Conditions
- Confusion
- Being tested
- TAVI : Transcatether Aortic Valve Implantation
- Keywords
- Hypnosis, Delirium, Transcatheter aortic valve implantation
- Medical subject headings
- Confusion, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVI : Transcatether Aortic Valve ImplantationProcedure or surgery
TAVI procedures will be either Medtronic Corevalve, or Edwards Sapien implantations, at operator's discretion. All procedures will be supervised by one of the two senior interventional cardiologists. Hypnosis sessions will be performed by two trained anesthesiologists, and Remifentanil sedations will be administered by the rest of the anesthesiologists staff. Postoperative care will be provided in the CICU for the 3 first postoperative days at least.
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis arm | Active comparator | TAVI procedures will be either Medtronic Corevalve, or Edwards Sapien implantations, at operator's discretion. All procedures will be supervised by one of the two senior interventional cardiologists. Hypnosis sessions will be performed by two trained anesthesiologists, and Remifentanil sedations will be administered by the rest of the anesthesiologists staff. Postoperative care will be provided in the CICU for the 3 first postoperative days at least. Receives: Procedure: TAVI : Transcatether Aortic Valve Implantation |
| Sedation arm | Placebo comparator | TAVI procedures will be either Medtronic Corevalve, or Edwards Sapien implantations, at operator's discretion. All procedures will be supervised by one of the two senior interventional cardiologists. Hypnosis sessions will be performed by two trained anesthesiologists, and Remifentanil sedations will be administered by the rest of the anesthesiologists staff. Postoperative care will be provided in the CICU for the 3 first postoperative days at least. Receives: Procedure: TAVI : Transcatether Aortic Valve Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a postoperative delirium episode
Assessment of the level of postoperative confusion will be measured at the CAM-ICU (Confusion Assessment Method Intensive Care Unit) scale. The CAM-ICU scale is a questionnaire based on 4 items. The diagnosis of delirium requires the presence of 3 of the 4 criteria. Criteria 1 and 2 are still required, with criteria 3 or 4.
Measured: 72 hours
Secondary outcomes (1)
Incidence of intraoperative complications
Intraoperative complications
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start11 Jun 2018
- Primary completion11 Jun 2020 (estimated)
- Study completion11 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConfusionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 arms : hypnosis group and sedation group
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marina Rubatti, Principal investigator, Hôpital Marie Lannelongue
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974269
- Sponsor's protocol ID
- 2018-A00563-52
- Acronym
- HYPSED
- Status last verified
- Jan 2020
- First submitted
- 23 Apr 2019
- Last updated
- 23 Jan 2020
- 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 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnosis Versus Intravenous Sedation With Concentration Objective (SIVOC) by Remifentanil During TAVI Procedures: Impact on Perioperative Confusion
- ClinicalTrials.gov ID
- NCT03974269
- Acronym / sponsor ID
- HYPSED / 2018-A00563-52
- Conditions
- Confusion
- Keywords
- Hypnosis, Delirium, Transcatheter aortic valve implantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 11 Jun 2020 (estimated)
- Study completion
- 11 Jun 2021 (estimated)
- First posted
- 4 Jun 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.
TAVI has become a credible alternative to conventional cardiac surgery in aged high-risk patients with aortic valve stenosis. A large part of these procedures are performed with sedation using remifentanil target-controlled infusion plus local anesthesia. However, a significant proportion of the patients experience postoperative delirium, with subsequent worsened outcomes, time-consuming interventions, and increased costs. The use of hypnosis before and during TAVI could decrease the incidence of postoperative delirium thanks to less opioids and hypnotics consumption. Thus, the investigators ought to evaluate the potential advantages of hypnosis vs. remifentanil target controlled-infusion during TAVI procedures.
Detailed description
Each included patient will randomly be assigned either to the hypnosis group or to the remifentanil group. Patients of the hypnosis group will have one preoperative and one perioperative hypnosis session with a qualified anesthesiologist. Patients of the remifentanil group will receive sedation with remifentanil, administered using a pre specified target controlled-infusion protocol.
Incidence of delirium will be recorded in the cardiac intensive care unit (CICU) during the first 72 postoperative hours, using the Confusion Assessment Method in the ICU (CAM-ICU). Incidence of other complications such as episodes of oxygen desaturation, vascular wound, stroke, general anesthesia requirement and inhospital death will be recorded, as well as procedure duration, hospital length of stay, patient satisfaction and operator comfort.
Transcatheter aortic valve implantation (TAVI) procedures are frequently complicated with postoperative delirium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 arms : hypnosis group and sedation group
| Arm | Type | Receives |
|---|---|---|
| Hypnosis arm | Active comparator | Procedure: TAVI : Transcatether Aortic Valve ImplantationTAVI procedures will be either Medtronic Corevalve, or Edwards Sapien implantations, at operator's discretion. All procedures will be supervised by one of the two senior interventional cardiologists. Hypnosis sessions will be performed by two trained anesthesiologists, and Remifentanil sedations will be administered by the rest of the anesthesiologists staff. Postoperative care will be provided in the CICU for the 3 first postoperative days at least. |
| Sedation arm | Placebo comparator | Procedure: TAVI : Transcatether Aortic Valve ImplantationTAVI procedures will be either Medtronic Corevalve, or Edwards Sapien implantations, at operator's discretion. All procedures will be supervised by one of the two senior interventional cardiologists. Hypnosis sessions will be performed by two trained anesthesiologists, and Remifentanil sedations will be administered by the rest of the anesthesiologists staff. Postoperative care will be provided in the CICU for the 3 first postoperative days at least. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients requiring transfemoral approach TAVI without general anesthesia
- For adult patients : age greater than or equal to 18 years
- Patients affiliated to a social security scheme
Key exclusion criteria (8 listed)
- Patient whose age is less than 18 years
- Approach with general anesthesia
- Patient not responding to Hypnosis: unmotivated, non-cooperating, not confident
- Other than transfemoral approach : carotid, trans-apical or sternotomy or thoracotomy procedure
- chronic psychosis, bilateral deafness without hearing aids,
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 |
|---|---|---|
| TAVI : Transcatether Aortic Valve ImplantationTAVI procedures will be either Medtronic Corevalve, or Edwards Sapien implantations, at operator's discretion. All procedures will be supervised by one of the two senior interventional cardiologists. Hypnosis sessions will be performed by two trained anesthesiologists, and Remifentanil sedations will be administered by the rest of the anesthesiologists staff. Postoperative care will be provided in the CICU for the 3 first postoperative days at least. | Procedure or surgery | Hypnosis arm, Sedation arm |
Primary outcome
Occurrence of a postoperative delirium episode
Time frame: 72 hours
Assessment of the level of postoperative confusion will be measured at the CAM-ICU (Confusion Assessment Method Intensive Care Unit) scale. The CAM-ICU scale is a questionnaire based on 4 items. The diagnosis of delirium requires the presence of 3 of the 4 criteria. Criteria 1 and 2 are still required, with criteria 3 or 4.
1 secondary outcome
Incidence of intraoperative complications
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- 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.
Marina Rubatti principal investigator
Hôpital Marie Lannelongue
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAVI : Transcatether Aortic Valve Implantation in people with Confusion, run by Centre Chirurgical Marie Lannelongue 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 3 inclusion and 8 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 23 Jan 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 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. Some participants in this study may receive a placebo. 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 Marina Rubatti (0033140948635, m.rubatti@hml.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of a postoperative delirium episode (time frame: 72 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 23 Jan 2020.