Risultati per: Il delirium

Introduction
Delirium, a common neuropsychiatric condition in hospitalised older adults, is associated with increased mortality, longer hospital stays and cognitive decline. The potential of melatonin to prevent delirium by improving sleep patterns and regulating circadian rhythms is promising, though existing evidence is mixed. This study aims to evaluate the efficacy of melatonin in preventing delirium in medically hospitalised patients aged 65 years and older.

Methods and analysis
This randomised, double-blind, placebo-controlled trial will enrol 240 patients aged 65 or older admitted to general medical wards at Sultan Qaboos University Hospital starting from September 2024. Participants will be randomly assigned to receive either 5 mg or 8 mg of melatonin or a placebo nightly for up to 5 days. The primary outcome is the incidence of delirium, assessed using the 3 min Diagnostic Confusion Assessment Method during the first 5 days. Secondary outcomes include the duration of delirium, sleep patterns and other clinical measures, such as hospital length of stay and 28-day readmission.

Ethics and dissemination
The study protocol has received ethical approval from the Medical Research Ethics Committee at Sultan Qaboos University (REF. NO. SQU-EC/0242024, MREC #3240). All participants or their legal proxies will provide informed consent prior to enrolment. Results will be disseminated through peer-reviewed publications and conference presentations, contributing to the global evidence base on delirium prevention strategies in hospitalised older adults.

Trial registration number
ClinicalTrials.gov under the identifier NCT06509191.

Background
Postoperative delirium (POD) is an acute neurocognitive impairment and is commonly observed in older patients with hip fractures. POD is associated with poor outcomes, including increased postoperative complications, prolonged hospitalisation, high costs and increased perioperative mortality. Therefore, reducing the occurrence of POD and improving cognitive abilities in older patients are critical and urgent. Transcutaneous auricular vagus nerve stimulation (TAVNS) is a simple, safe, non-invasive treatment and has great potential to improve cognitive function. This clinical study will evaluate the effectiveness of TAVNS in reducing the incidence of POD in older patients and further elucidate the possible underlying mechanisms.

Methods and analysis
This randomised, double-blind, single-centre controlled trial will enroll 154 older patients undergoing hip fracture surgery, who will be randomly assigned to the TAVNS group (n=77), receiving TAVNS from 1 hour before anaesthetic induction to the end of the surgery, or the sham stimulation group (n=77), receiving sham stimulation in the same manner. The primary outcome measure will be the incidence of POD during the first 7 days post-surgery, as assessed by the confusion assessment method for the intensive care unit. The secondary outcomes include the incidence of delayed neurocognitive recovery; serum acetylcholinesterase and butyrylcholinesterase levels; the concentrations of tumour necrosis factor-α, interleukin-1β, interleukin-6 and S100β; unplanned intensive care unit admission rates; the length and cost of hospital stay; the incidence of postoperative complications during hospitalisation; and mortality at 1 month, 6 months and 1 year after surgery.

Ethics and dissemination
This study was approved by the Ethics Committee of the Chongqing Traditional Chinese Medicine Hospital on 15 May 2024 (2024-KY-HY-13). The findings will be published in the international peer-reviewed academic journals and presented orally at academic conferences.

Trial registration number
ChiCTR2400085508.

Introduction
Intensive care unit (ICU) delirium is an acute brain dysfunction that affects up to 7 out of 10 patients admitted to ICUs. Patients who develop ICU delirium cannot think clearly, have trouble paying attention, do not understand what is happening around them and may see or hear things that are not there. ICU delirium increases the time patients spend in ICUs and hospitals and therefore healthcare costs. ICU delirium is also associated with increased mortality and dementia in the longer term. ICU delirium prevention and management strategies are likely to include both pharmacological and non-pharmacological components as part of a complex intervention, but it is unclear which components should be included. The objective of this meta-review is to systematically map the quantity and certainty of the available evidence from reviews and meta-analyses of randomised controlled trials (RCTs) of pharmacological and non-pharmacological interventions, which will be used to design a multicomponent intervention to prevent and manage ICU delirium.

Methods and analysis
A systematic search strategy was performed in MEDLINE (Ovid), Embase (Elsevier), Cochrane Database of Systematic Reviews, Scopus, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO and Web of Science (from inception to 26 September 2023), as well as Epistemonikos (from inception to 19 July 2023). We will include all critically ill adults (aged≥18 years) and any ICU delirium prevention or management intervention (pharmacological or non-pharmacological). For pharmacological interventions, we will include reviews of RCTs. For non-pharmacological interventions, we will consider reviews of RCTs, quasi-experimental and cohort studies. We will use the International Consensus Study (Del-COrS) core outcome set for research evaluating interventions to prevent or manage ICU delirium and synthesise our findings using quantitative data description methods. We will involve our Patient and Public Involvement group of people who experienced ICU delirium to develop and comment on such aspects as the research question, methodology and which outcomes are most important.

Ethics and dissemination
No ethical approval is required for this study. The results of this meta-review will be disseminated through peer-reviewed publications and conferences. They will also form part of an evidence map and logic model for the prevention and management of ICU delirium.

PROSPERO registration number
CRD42023473260

Introduction
Delirium is a neuropathological syndrome that is associated with several negative outcomes. Nursing home residents are vulnerable to developing delirium. Valid prevalence data and associated factors are not yet available for Germany. Therefore, the aim of the prevalence study of the DeliA project (Delirium in Nursing Homes) is to assess the prevalence of delirium and its associated factors in 750 nursing home residents.

Methods and analysis
Trained registered nurses from each participating nursing home will collect the data in a multicentre cross-sectional study. The inclusion criteria for residents are valid informed consent, age ≥65 years and sufficient language skills. The exclusion criteria are aphasia, coma, deafness or end-of-life status. The 4 ‘A’s Test will be used as the primary measurement. Delirium motor subtypes will be determined using the Delirium Motor Subtype Scale. Covariables for associated factors, including functional impairments, pain, cognitive status and nutritional status, are assessed through standardised measurements. Moreover, data such as prescribed drugs or medical diagnosis, hearing impairment or falls will be assessed from the nursing records. Furthermore, the Drug Burden Index will be calculated, and associated factors will be determined using a logistic regression model. The period for data collection in participating nursing homes is planned for 2 consecutive weeks in April 2024.

Ethics and dissemination
This study was approved by the Ethics Committee of Witten/Herdecke University (no. 82/2023). Findings will be published in peer-reviewed journals and presented at conferences.

Registration
https://osf.io/xkfvh/ (DOI 10.17605/OSF.IO/XKFVH).

Introduction
Delirium is a common acute cognitive impairment characterised by confusion, disorientation and attention deficits, particularly prevalent in intensive care unit (ICU) settings. Given its significant impact on patients, caregivers and healthcare resources, preventing delirium in patients in the ICU is of paramount importance. This is the first randomised-controlled trial designed to evaluate the effects of a virtual reality-based sensory stimulation intervention on preventing delirium in ICU patients.

Methods and analysis
We employed a paired randomisation method to match eligible participants based on a validated delirium risk scoring model for patients in the ICU. The study will commence in September 2024 and conclude in June 2026. A consecutive sample of 324 patients in the ICU admitted to the study setting will be recruited. Eligible participants will be randomly allocated to receive either virtual reality-based sensory stimulation in addition to usual care or usual care alone. The virtual reality-based sensory stimulation intervention will last for up to 14 days, with all interventions administered by a research team. We define delirium-free days over a 14-day period as the primary outcome. The secondary outcomes will include delirium incidence, duration and severity; patients’ psychological well-being (post-traumatic stress disorder, sleep quality and ICU memory); patients’ clinical outcomes and other outcomes (quality of life, independence and cognitive function). Data will be collected at baseline, post-intervention and 6 months post-intervention. Two independent t-tests or Wilcoxon-Mann-Whitney tests will be used for continuous variables, while 2 or Fisher’s exact tests will be employed for categorical variables. The analysis will adhere to both the intention-to-treat and per-protocol principles. Additionally, mixed-effects models and subgroup analysis will be planned.

Ethics and dissemination
This protocol was approved by the Research Ethics Committee of Shenzhen Hospital of Southern Medical University (NYSZYYEC20230068). All participants or their family caregivers will provide written informed consent. Results will be disseminated through scientific publications, and presentations at local and international conferences.

Trial registration number
ClinicalTrials.gov NCT06153472. Trial registration date: 22 November 2023.

Introduction
Prone positioning with head rotation can influence cerebral haemodynamics, potentially affecting cerebral perfusion and oxygenation. Elderly patients with impaired brain perfusion and oxygenation are at an increased risk of developing postoperative delirium (POD). Despite this, few studies have explored whether head orientation during prone positioning contributes to POD in older adults, an aspect often overlooked by clinicians. This study aimed to evaluate the impact of head orientation during prone positioning on the incidence of POD in elderly patients undergoing thoracolumbar spine surgery.

Methods and analysis
This study is a single-centre, randomised, single-blind trial, with the assessors blinded to the intraoperative head position. Eligible participants are patients aged ≥65 years undergoing elective thoracolumbar spine surgery. A total of 500 patients will be randomly assigned to either the prone position with the head centred, or the prone position with the head deviated. The primary outcome is the incidence of POD, measured using the 3 min Diagnostic Interview for Confusion Assessment Method (3D-CAM) until postoperative day 5. Secondary outcomes include the severity of POD assessed by the Memorial Delirium Assessment Scale (MDAS), postoperative cognitive impairment evaluated using the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA), intraoperative regional cerebral oxygen saturation (rSO2), changes in vertebrobasilar artery and middle cerebral artery haemodynamics, and plasma levels of calcium channel-binding protein S100 subunit beta (S100B) and neuron-specific enolase (NSE).

Ethics and dissemination
Ethical approval was obtained from Yancheng No. 1 People’s Hospital Ethics Examination Committee (2023-K-120–01). The findings will be disseminated through presentations at annual conferences and publications in scientific journals.

Trial registration number
ChiCTR2300078839.

Introduction
The effect of different anaesthetics on the incidence of postoperative delirium is still not entirely clear. Therefore, we will evaluate the effect of desflurane versus sevoflurane versus propofol for the maintenance of anaesthesia on the incidence of postoperative delirium in older adults undergoing moderate- to high-risk major non-cardiac surgery. We will further compare the incidences of delayed neurocognitive recovery, long-term postoperative neurocognitive disorder, postoperative nausea and vomiting between the groups.

Methods and analysis
In this multicentre, prospective, observer-blinded, randomised controlled clinical trial, we will include 1332 patients ≥65 years of age undergoing moderate- to high-risk major non-cardiac surgery lasting at least 2 hours. Patients will be randomly 1:1:1 assigned to receive desflurane, sevoflurane or propofol for anaesthesia. Maintenance of anaesthesia will be performed in a goal-directed manner using processed electroencephalography with an intraoperative goal of bispectral index 40–60. Our primary outcome will be the incidence of postoperative delirium within the first five postoperative days. Postoperative delirium will be assessed using the three-dimensional-confusion assessment method (3D-CAM) or CAM-intensive care unit (ICU) in the morning and evening of the first five postoperative days by blinded study personnel. The primary outcome, the incidence of postoperative delirium, will be compared between the three study groups using a 2 test. Furthermore, a logistic regression model for the incidence of postoperative delirium will be performed, accounting for randomised groups as well as other predefined confounding factors.

Ethics and dissemination
This clinical trial has been approved by the ethics committee and the Federal Office for Safety in Healthcare as the competent authority for clinical trials in Austria. The results of this trial will be published in a peer-reviewed journal.

Trial registration number
ClinicalTrials.gov NCT05990790.

To the Editor A recent trial concluded that among older adults undergoing cardiac surgery, electroencephalography (EEG)-guided anesthetic administration to minimize EEG suppression, compared with usual care, did not decrease the incidence of postoperative delirium. We have several concerns about this trial.

In Reply We thank Dr Xiang and colleagues for their Letter, in which they express concern that transfusion of platelets, prolonged aortic cross-clamp time, sedation protocols in the ICU, delirium assessment methods, and different EEG monitoring devices might have confounded the results of the ENGAGES-Canada trial.

Introduction
Postoperative delirium (POD) is a common neurological complication after surgery among older patients, characterised by acute disturbances in consciousness, attention and cognition, usually occurring within 24–72 hours after surgery. POD has a significant impact on the prognosis of older patients undergoing major cardiovascular surgery, including increased length of hospital stay, hospital costs and readmission rates, with an incidence rate as high as 26%–52%. Computerised cognitive training (CCT) refers to difficulty-adaptive training in cognitive domains such as attention, memory and logical reasoning, using systematically designed tasks. Existing studies have shown that CCT has reduced the risk of delirium in non-cardiac surgery patients with at least minimal compliance. The purpose of this study is to investigate the effects of preoperative CCT on the incidence of POD in older patients undergoing elective cardiac surgery, to clarify the dose–effect relationship between different training time of preoperative CCT and POD and to explore the minimum effective time target that can significantly lower the incidence of POD.

Methods and analysis
This is a prospective, single-blind, randomised controlled trial that aims to enrol 261 older patients scheduled for elective cardiac surgery at the Affiliated Hospital of Xuzhou Medical University. The patients will be randomised into three groups: group C will be the routine care group (no CCT prior to surgery); group L will be the low-dose time group (with a total of 5 hours of CCT prior to surgery) and group H will be the high-dose time group (with a total of 10 hours of CCT prior to surgery). The primary outcome is the incidence of delirium within 7 days after surgery. Secondary outcomes include postoperative mild neurocognitive disorder (NCD) and postoperative major NCD (30 days up to 1 year), time of onset and duration and severity of delirium, and all-cause mortality within 1 year after surgery. The results of this study are of significant importance for establishing effective, patient-centred and low-risk prevention strategies for POD/postoperative NCD.

Ethics and dissemination
This study protocol has been approved by the Ethics Committee of the Affiliated Hospital of Xuzhou Medical University (Ethics Number: XYFY2023-KL149-01). All participants will provide written informed consent, and the results of the study will be published in international peer-reviewed academic journals and presented at academic conferences.

Trial registration number
ChiCTR2300072806.

Circulation, Volume 150, Issue Suppl_1, Page A4145052-A4145052, November 12, 2024. Introduction:Transcatheter Aortic Valve Replacement (TAVR) is an increasingly common procedure for patients with severe aortic stenosis. However, postprocedural delirium remains a significant complication, impacting patient outcomes. This study aims to evaluate the inpatient outcomes of delirium in patients undergoing TAVR.Methods:We performed a retrospective cohort study using the National Inpatient Sample 2018-2020, including patients who underwent TAVR with and without delirium. Propensity score matching was performed using the variables age, elective admission, sex, and comorbid conditions (congestive heart failure, cardiac arrhythmias, peripheral vascular disorders, hypertension, diabetes, chronic kidney disease, coagulopathy, and obesity) to compare patients with and without delirium. Weighted samples were utilized and p value

Circulation, Volume 150, Issue Suppl_1, Page A4143377-A4143377, November 12, 2024. Background:Intraoperative hypotension has been associated with several adverse outcomes including postoperative delirium (POD). While current guidelines recommend an intraoperative mean arterial pressure (MAP) above 65 mmHg during non-cardiac operations, there is no clear consensus regarding the optimal MAP threshold for cardiac surgery patients. We aim to determine an intraoperative MAP threshold that is associated with a reduced risk of delirium following cardiac surgery.Methods:We established a retrospective observational cohort of adult patients who underwent cardiac surgery within our healthcare system between 2014 and 2021. After excluding patients with preoperative delirium or with no documented Confusion Assessment Method for the ICU (CAM-ICU) result, the final cohort included 4,060 patients. Delirium was defined as a positive CAM-ICU test in a patient with a Richmond Agitation-Sedation Scale (RASS) >= -3. Intraoperative hypotension was defined as the number of MAP measurements below a threshold,k, normalized by the total number of MAP measurements. We experimented withk= 55, 60, 65, …, and 85 mmHg. Separate multivariable logistic regression analyses were conducted for each threshold,k, to investigate its association with POD.Results:POD was documented in 369 patients (9.1%). Patients with POD had higher median age (70 vs 66 years, p

Circulation, Volume 150, Issue Suppl_1, Page A4143192-A4143192, November 12, 2024. Background:Delirium and atrial fibrillation (AF) are two common complications after cardiac surgery. Each of them has been associated with several other adverse outcomes including mortality and prolonged hospital stay. We sought to determine the frequency of the co-incidence of postoperative delirium (POD) and postoperative atrial fibrillation (POAF) and its association with risk of one-year mortality following cardiac surgery compared to POD or POAF alone.Methods:We established a retrospective observational cohort of adult patients who underwent cardiac surgery within our healthcare system between 2014 and 2022. POD was defined as a postoperative positive CAM-ICU test in a patient with a Richmond Agitation-Sedation Scale (RASS) >= -3. POAF was defined as a documented AF event within 30 days after surgery. Patients were stratified into four distinct groups: Co-incidence of POD and POAF, POD only, POAF only, and None (i.e., neither complication).Results:Among 6136 patients, there were 256 (4.2%) patients experienced both POD and POAF, 221 (3.6%) had POD only, 2127 (34.7%) had POAF only, and 3532 (57.6%) had neither complication. The overall one-year mortality rate was 5.8%, with mortality rates of 21.9% for the co-occurrence group, 14.0% for the POD only group, 6.8% for the POAF only group, and 3.5% for the group with neither complication. The differences in one-year survival among the four groups are shown inFigure 1. Multivariable logistic regression analysis identified the top predictors for one-year mortality as co-incidence of POD and POAF (adjusted odds ratio (OR)=3.98, 95% CI=2.69-5.85, p

Circulation, Volume 150, Issue Suppl_1, Page A4145368-A4145368, November 12, 2024. Background:Postoperative delirium is a prevalent complication following cardiac surgery. In recents studies, dexmedetomidine has been proposed as a potential alternative to mitigate this condition. This meta-analysis aimed to evaluate the efficacy of dexmedetomidine for prevention of postoperative delirium after cardiac surgery.Methods:We systematically searched PubMed, Embase, and Cochrane databases for randomized controlled trials (RCTs) analyzing the efficacy of dexmedetomidine compared to placebo in patients undergoing cardiac surgeries. We pooled risk ratios (RR) for binary outcomes with 95% confidence intervals (CI) with a random-effects model. We used R version 4.3.2 for all statistical analyses.Results:Our meta-analysis included 12 RCTs comprising 3016 patients, of whom 1515 (50.2%) were randomized to dexmedetomidine. The mean age ranged from 43 to 74 years among studies. Compared with placebo, dexmedetomidine significantly reduced the incidence of postoperative delirium (RR 0.67; 95% CI: 0.48 to 0.95; p

Introduction
Neurosurgery is a risk factor for postoperative delirium. Dexmedetomidine has a potential effect on reducing postoperative delirium. We aim to test the primary hypothesis that perioperative administration of dexmedetomidine reduces the incidence of postoperative delirium in patients undergoing neurosurgical resections of temporal glioma.

Methods
This is a single-centre, randomised, blinded and parallel-group controlled trial. A total of 366 patients will be randomised to either dexmedetomidine group (n=183) or placebo group (n=183). Subjects assigned to dexmedetomidine group will be given a continuous infusion at 0.4 µg/kg/h after anaesthesia induction until dural closure and then immediately receive an infusion of dexmedetomidine at 0.08 µg/kg/h by intravenous analgesia pump during the first 48 hours postoperatively. Patients in the placebo group will be given comparable volumes of normal saline, and intravenous analgesia pumps contain equal amounts of sufentanil and antiemetics, but no dexmedetomidine. The primary outcome is the incidence of postoperative delirium, which will be assessed with the Confusion Assessment Method two times per day during the first five postoperative days.

Ethics and dissemination
The protocol (V.1.1) has been approved by the medical ethics committee of Beijing Tiantan Hospital, Capital Medical University (KY2023-186-02). The findings of this study will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals.

Trial registration number
NCT06164314.

Introduction
Delirium, a clinical manifestation of acute encephalopathy, is associated with extended hospitalisation, long-term cognitive dysfunction, increased mortality and high healthcare costs. Despite intensive research, there is still no targeted treatment. Delirium is characterised by electroencephalography (EEG) slowing, increased relative delta power and decreased functional connectivity. Recent studies suggest that transcranial alternating current stimulation (tACS) can entrain EEG activity, strengthen connectivity and improve cognitive functioning. Hence, tACS offers a potential treatment for augmenting EEG activity and reducing the duration of delirium. This study aims to evaluate the feasibility and assess the efficacy of tACS in reducing relative delta power.

Methods and analysis
A randomised, double-blind, sham-controlled trial will be conducted across three medical centres in the Netherlands. The study comprises two phases: a pilot phase (n=30) and a main study phase (n=129). Participants are patients aged 50 years and older who are diagnosed with delirium using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision criteria (DSM-5-TR), that persists despite treatment of underlying causes. During the pilot phase, participants will be randomised (1:1) to receive either standardised (10 Hz) tACS or sham tACS. In the main study phase, participants will be randomised to standardised tACS, sham tACS or personalised tACS, in which tACS settings are tailored to the participant. All participants will undergo daily 30 min of (sham) stimulation for up to 14 days or until delirium resolution or hospital discharge. Sixty-four-channel resting-state EEG will be recorded pre- and post the first tACS session, and following the final tACS session. Daily delirium assessments will be acquired using the Intensive Care Delirium Screening Checklist and Delirium Observation Screening Scale. The pilot phase will assess the percentage of completed tACS sessions and increased care requirements post-tACS. The primary outcome variable is change in relative delta EEG power. Secondary outcomes include (1) delirium duration and severity, (2) quantitative EEG measurements, (3) length of hospital stay, (4) cognitive functioning at 3 months post-tACS and (5) tACS treatment burden. Study recruitment started in April 2024 and is ongoing.

Ethics and dissemination
The study has been approved by the Medical Ethics Committee of the Utrecht University Medical Center and the Institutional Review Boards of all participating centres. Trial results will be disseminated via peer-reviewed publications and conference presentations.

Trial registration number
NCT06285721.