Postoperative DeliriumNCT02585128
Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation
A study testing Delirium assessment, MMSE (Mini Mental State Examination) and Barthel index in people with Postoperative Delirium, run by Cardiocentro Ticino at 1 site in Switzerland.
Trial summary
Patients undergoing transcatheter aortic valve implantation (TAVI) have distinctive characteristics: they are old, frail, with several co-morbidities and take multiple medications. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Delirium assessment, MMSE (Mini Mental State Examination) and Barthel index
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2015to Jan 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65>years
- Patients undergoing transcatheter aortic valve implantation
- Patients have given informed consent for participation at the study
Who cannot join
- Patient suffering from delirium (CAM diagnosis) at recruitment
- Inability to understand the national languages
- Emergency procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence and Risk Factors of Acute Postoperative Confusion State After Trans-catheter Aortic Valve Implantation (TAVI)
Patients undergoing transcatheter aortic valve implantation (TAVI) have distinctive characteristics: they are old, frail, with several co-morbidities and take multiple medications. Hemodynamic instability, cerebral embolism, sedation, general anesthesia and hospitalization in intensive care expose those patients to postprocedural delirium.
Acute neurocognitive dysfunctions are associated with adverse outcomes in these population.
The objective of this study is to determine the incidence of delirium and neurocognitive disorders in elderly patients after TAVI.
- Conditions
- Postoperative Delirium
- Being tested
- Delirium assessment, MMSE (Mini Mental State Examination), Barthel index, HADS (Hospital Anxiety and Depression Scale), MNA-SF (Mini Nutritional Assessment - Short Form)
- Keywords
- Delirium, Transcatheter Aortic Valve Implantation, Elderly
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delirium assessmentOther
During the first post-procedural five days all patients will be evaluated on a daily basis for delirium occurrence by the CAM (Confusion Assessment Method) or CAM - ICU (Confusion Assessment Method - Intensive Care Unit)
MMSE (Mini Mental State Examination)Other
Barthel indexOther
HADS (Hospital Anxiety and Depression Scale)Other
MNA-SF (Mini Nutritional Assessment - Short Form)Other
NIRS (Near-Infrared Spectroscopy)Device
Regional cerebral oxygen saturation monitoring during TAVI procedure
CIRS (Cumulative Illness Rating Scale)Other
| Study group | Role | What they receive |
|---|---|---|
| Patients following TAVI | Other | Not described Receives: Other: Delirium assessment; Other: MMSE (Mini Mental State Examination); Other: Barthel index; Other: HADS (Hospital Anxiety and Depression Scale); Other: MNA-SF (Mini Nutritional Assessment - Short Form); Device: NIRS (Near-Infrared Spectroscopy); Other: CIRS (Cumulative Illness Rating Scale) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium
The primary outcome is incidence of delirium. Delirium screening will be carry out using the CAM or CAM-ICU in accordance with local hospital clinical delirium-screening guidelines. The assessment of presence of Delirium will be perform by clinician with CAM in agreement with Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM IV). CAM is standardized method to enable non-psychiatrically trained clinicians to identify delirium and assesses nine features of delirium: (1) acute onset, (2) inattention, (3) disorganized thinking, (4) altered level of consciousness, (5) disorientation, (6) memory impairment, (7) perceptual disturbances, (8) psychomotor agitation or retardation and (9) altered sleep-wake cycle. Delirium is diagnosed when feature 1 and 2 are present and either 3 or 4 are displayed.
Measured: Day 1-5 after transcatheter aortic valve implantation
Secondary outcomes (7)
Risk factors for postoperative delirium
Association between incidence of delirium and patient vulnerabilities, exposure to noxious or precipitating factors. The risk factors will be divided in pre-procedural, intra-procedural and post-procedural
Measured: Baseline, intra-operative and days 1-5 after transcatheter aortic valve implantation
Onset of delirium
Measured: Day 1-5 after transcatheter aortic valve implantation
Complications of delirium
Complications delirium related
Measured: Day 1-5 after transcatheter aortic valve implantation
Type of delirium
Delirium classification according to Delirium Motor Subtype Scale (DMSS-4)
Measured: Day 1-5 after transcatheter aortic valve implantation
Trajectories of neurocognitive function
Change of Mini-Mental State Examination (MMSE)
Measured: Changes from baseline up to 5 day and 3-months
Trajectories of functional abilities
Change of Barthel Index (for Activities of Daily Living, ADL)
Measured: Changes from baseline up to 5 day and 3-months
Mortality
Postoperative survival
Measured: 30-days, 3-months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2019
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiocentro Ticino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiziano Cassina, Cardiocentro Ticino
- Investigators
- Tiziano Cassina, MD, Principal investigator, Cardiocentro Ticino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585128
- Sponsor's protocol ID
- DELTAVI-CCT-ICU-2015
- Status last verified
- Apr 2024
- First submitted
- 1 Oct 2015
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors of Acute Postoperative Confusion State After Trans-catheter Aortic Valve Implantation (TAVI)
- ClinicalTrials.gov ID
- NCT02585128
- Acronym / sponsor ID
- DELTAVI-CCT-ICU-2015
- Conditions
- Postoperative Delirium
- Keywords
- Delirium, Transcatheter Aortic Valve Implantation, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Cardiocentro TicinoUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- May 2019 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 23 Oct 2015 (estimated)
- 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.
Patients undergoing transcatheter aortic valve implantation (TAVI) have distinctive characteristics: they are old, frail, with several co-morbidities and take multiple medications. Hemodynamic instability, cerebral embolism, sedation, general anesthesia and hospitalization in intensive care expose those patients to postprocedural delirium.
Acute neurocognitive dysfunctions are associated with adverse outcomes in these population.
The objective of this study is to determine the incidence of delirium and neurocognitive disorders in elderly patients after TAVI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients following TAVI | Other | Other: Delirium assessment, Other: MMSE (Mini Mental State Examination), Other: Barthel index, Other: HADS (Hospital Anxiety and Depression Scale), Other: MNA-SF (Mini Nutritional Assessment - Short Form), Device: NIRS (Near-Infrared Spectroscopy), Other: CIRS (Cumulative Illness Rating Scale) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age 65>years
- Patients undergoing transcatheter aortic valve implantation
- Patients have given informed consent for participation at the study
Key exclusion criteria (3 listed)
- Patient suffering from delirium (CAM diagnosis) at recruitment
- Inability to understand the national languages
- Emergency procedures
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 |
|---|---|---|
| Delirium assessmentDuring the first post-procedural five days all patients will be evaluated on a daily basis for delirium occurrence by the CAM (Confusion Assessment Method) or CAM - ICU (Confusion Assessment Method - Intensive Care Unit) | Other | Patients following TAVI |
| MMSE (Mini Mental State Examination) | Other | Patients following TAVI |
| Barthel index | Other | Patients following TAVI |
| HADS (Hospital Anxiety and Depression Scale) | Other | Patients following TAVI |
| MNA-SF (Mini Nutritional Assessment - Short Form) | Other | Patients following TAVI |
| NIRS (Near-Infrared Spectroscopy)Regional cerebral oxygen saturation monitoring during TAVI procedure | Device | Patients following TAVI |
| CIRS (Cumulative Illness Rating Scale) | Other | Patients following TAVI |
Primary outcome
Incidence of delirium
Time frame: Day 1-5 after transcatheter aortic valve implantation
The primary outcome is incidence of delirium. Delirium screening will be carry out using the CAM or CAM-ICU in accordance with local hospital clinical delirium-screening guidelines. The assessment of presence of Delirium will be perform by clinician with CAM in agreement with Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM IV). CAM is standardized method to enable non-psychiatrically trained clinicians to identify delirium and assesses nine features of delirium: (1) acute onset, (2) inattention, (3) disorganized thinking, (4) altered level of consciousness, (5) disorientation, (6) memory impairment, (7) perceptual disturbances, (8) psychomotor agitation or retardation and (9) altered sleep-wake cycle. Delirium is diagnosed when feature 1 and 2 are present and either 3 or 4 are displayed.
7 secondary outcomes
Risk factors for postoperative delirium
Time frame: Baseline, intra-operative and days 1-5 after transcatheter aortic valve implantation
Onset of delirium
Time frame: Day 1-5 after transcatheter aortic valve implantation
Complications of delirium
Time frame: Day 1-5 after transcatheter aortic valve implantation
Type of delirium
Time frame: Day 1-5 after transcatheter aortic valve implantation
Trajectories of neurocognitive function
Time frame: Changes from baseline up to 5 day and 3-months
Trajectories of functional abilities
Time frame: Changes from baseline up to 5 day and 3-months
Mortality
Time frame: 30-days, 3-months and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
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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.
Tiziano Cassina, MD principal investigator
Cardiocentro Ticino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delirium assessment, MMSE (Mini Mental State Examination) and Barthel index in people with Postoperative Delirium, run by Cardiocentro Ticino at 1 site in Switzerland.
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: finished, as of the sponsor's last update on 18 Apr 2024. 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 Switzerland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of delirium (time frame: Day 1-5 after transcatheter aortic valve implantation). 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 18 Apr 2024.