DeliriumDELIRIUMTAVINCT03323619
Impact of Anesthesia Technique on Post-operative Delirium After Transcatheter Aortic Valve Implantation
An observational study of Delirium and Post-Op Complication, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Aortic stenosis is a frequent valvulopathy in Europe and North America. It occurs mainly over 65 years (2-7% of the population over 65 years). Treatment of symptomatic stenosis is an indication of aortic valve replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Post-Op Complication, Anesthesia
- What is being tested?
- anesthesia type
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2017to 2 Nov 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 years and older
- All sexes
- Adult, Older adult
Study population: All patient admitted for TAVI intervention
Who may be able to join
- Hospital admission for TAVI femoral way
- Age > 18 years
- Psychiatric disease
Who cannot join
- Opposition of the operator (Interventional Cardiologist or Surgeon) to one of the two anesthesia technique
- Contraindication to local anesthesia with sedation: agitation, delirium, allergy to local anesthetics, risk of inhalation
- Opposition of the patient to use his data for research
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU - Hopital de Brabois
Nancy, Lorraine, 54000
FRITZ Caroline, +33383157379, fritzcaro@gmail.com
MATTEI Matthieu, +33383153521, m.mattei@chru-nancy.fr
About this study
Aortic stenosis is a frequent valvulopathy in Europe and North America. It occurs mainly over 65 years (2-7% of the population over 65 years). Treatment of symptomatic stenosis is an indication of aortic valve replacement. For patients with high surgical risk (EuroSCORE II> 6), TAVI (Transcatheter Aortic Valve Implantation) is recommended. This type of procedure concerns elderly patients (75-80 years on average in the literature) therefore the anesthesia technique must be optimal. The postoperative complications are, on the one hand, well-described surgical complications (Cardiogenic shock, bleeding, rhythm disorders, renal insufficiency) and, on the other hand, those related to anesthesia which are less well characterized. There is no consensus on best anesthesia technique for TAVI procedure managment. Between teams practices are different. It may consist of general anesthesia (GA) or local anesthesia with sedation (LASed). Elderly anesthesia has specific complications, including acute cerebral disturbances (delirium) usually occurring within 24 to 48 hours postoperatively and up to 7 days. It is recommended to screen delirium for patients admitted in intensive care using the CAM-ICU scale. The aim of the study is to observe the impact of the anesthesia technique (GA versus LASed) on delirium in post-operative aortic valve replacement with TAVI procedure
- Conditions
- Delirium, Post-Op Complication, Anesthesia, Aortic Valve Disease
- Being tested
- anesthesia type
- Keywords
- Transcatheter aortic valve replacement, Anesthesia technique, Delirium
- Medical subject headings
- Delirium, Postoperative Complications, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anesthesia typeProcedure or surgery
No intervention. General anesthesia or local anesthesia with sedation are decided by the physicien according to his usual practice
| Study group | Role | What they receive |
|---|---|---|
| GA | No intervention. General anesthesia is decided by the physicien according to his usual practice Receives: Procedure: anesthesia type | |
| LASed | No intervention. Local anesthesia with sedation is decided by the physicien according to his usual practice Receives: Procedure: anesthesia type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
post-operative delirium after TAVI
Measured: 7 days
Secondary outcomes (1)
ICU stay
duration of stay in ICU
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start2 Nov 2017
- Primary completion2 Aug 2020 (estimated)
- Study completion2 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MATTEI Mathieu, MD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323619
- Sponsor's protocol ID
- PSS2017/DELIRIUMTAVI-MATTEI/YB
- Acronym
- DELIRIUMTAVI
- Status last verified
- Sep 2018
- First submitted
- 24 Oct 2017
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anesthesia Technique on Post-operative Delirium After Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT03323619
- Acronym / sponsor ID
- DELIRIUMTAVI / PSS2017/DELIRIUMTAVI-MATTEI/YB
- Conditions
- Delirium, Post-Op Complication, Anesthesia, Aortic Valve Disease
- Keywords
- Transcatheter aortic valve replacement, Anesthesia technique, Delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 2 Aug 2020 (estimated)
- Study completion
- 2 Nov 2020 (estimated)
- First posted
- 27 Oct 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.
Aortic stenosis is a frequent valvulopathy in Europe and North America. It occurs mainly over 65 years (2-7% of the population over 65 years). Treatment of symptomatic stenosis is an indication of aortic valve replacement. For patients with high surgical risk (EuroSCORE II> 6), TAVI (Transcatheter Aortic Valve Implantation) is recommended. This type of procedure concerns elderly patients (75-80 years on average in the literature) therefore the anesthesia technique must be optimal. The postoperative complications are, on the one hand, well-described surgical complications (Cardiogenic shock, bleeding, rhythm disorders, renal insufficiency) and, on the other hand, those related to anesthesia which are less well characterized. There is no consensus on best anesthesia technique for TAVI procedure managment. Between teams practices are different. It may consist of general anesthesia (GA) or local anesthesia with sedation (LASed). Elderly anesthesia has specific complications, including acute cerebral disturbances (delirium) usually occurring within 24 to 48 hours postoperatively and up to 7 days. It is recommended to screen delirium for patients admitted in intensive care using the CAM-ICU scale. The aim of the study is to observe the impact of the anesthesia technique (GA versus LASed) on delirium in post-operative aortic valve replacement with TAVI procedure
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GA | – | Procedure: anesthesia typeNo intervention. General anesthesia is decided by the physicien according to his usual practice |
| LASed | – | Procedure: anesthesia typeNo intervention. Local anesthesia with sedation is decided by the physicien according to his usual practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patient admitted for TAVI intervention
Key inclusion criteria (3 listed)
- Hospital admission for TAVI femoral way
- Age > 18 years
- Psychiatric disease
Key exclusion criteria (3 listed)
- Opposition of the operator (Interventional Cardiologist or Surgeon) to one of the two anesthesia technique
- Contraindication to local anesthesia with sedation: agitation, delirium, allergy to local anesthetics, risk of inhalation
- Opposition of the patient to use his data for research
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 |
|---|---|---|
| anesthesia typeNo intervention. General anesthesia or local anesthesia with sedation are decided by the physicien according to his usual practice | Procedure or surgery | GA, LASed |
Primary outcome
Delirium
Time frame: 7 days
post-operative delirium after TAVI
1 secondary outcome
ICU stay
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
MATTEI Mathieu, MD principal investigator
Central Hospital, Nancy, France
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 Delirium and Post-Op Complication, run by Central Hospital, Nancy, France 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 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: status not confirmed, as of the sponsor's last update on 6 Sep 2018. 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 FRITZ Caroline, MD (+33383157379, fritzcaro@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium (time frame: 7 days). 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 Sep 2018.