Risultati per: Il delirium

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.

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.

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.

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 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 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 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 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.

Introduction
Elderly patients are at a high risk of postoperative delirium (POD), leading to increased postoperative morbidity and mortality. The use of dexmedetomidine and depth of anaesthesia may influence POD. This study aims to determine the effects of dexmedetomidine infusion versus normal saline placebo during light versus deep anaesthesia on POD among elderly patients undergoing major non-cardiac surgery.

Methods and analysis
This prospective, multicentre, randomised, controlled, factorial trial will be conducted at three tertiary hospitals in Jiangsu, China. We will recruit a total of 420 patients who are at least 60 years old and undergoing major non-cardiac surgery (thoracic, abdominal, urology, orthopaedic and spine surgery) under general anaesthesia. Patients will be randomised (1:1:1:1) to receive one of four anaesthesia regimens: (1) dexmedetomidine and light anaesthesia, (2) dexmedetomidine and deep anaesthesia, (3) placebo and light anaesthesia or (4) placebo and deep anaesthesia. Dexmedetomidine will be infused at 0.5 µg/kg/h throughout surgery, and intraoperative bispectral index target will be 55 for light anaesthesia and 40 for deep anaesthesia. The primary outcome is the occurrence of POD during the first 7 days postoperatively or until hospital discharge, assessed using the 3-min Confusion Assessment Method two times per day. The secondary outcomes include days with POD, type of POD, pain scores at rest and on movement at 24 and 48 hours postoperatively, patient-controlled intravenous fentanyl consumption during 0–24 and 24–48 hours postoperatively, hypotension, bradycardia, postoperative nausea and vomiting, non-delirium complications, length of postoperative hospital stay, 30-day cognitive function and 30-day mortality. Data will be analysed on a modified intention-to-treat basis.

Ethics and dissemination
This trial was approved by the Ethics Committee of the First Affiliated Hospital of Soochow University and each participating centre. The trial results will be published in a peer-reviewed journal.

Trial registration
Chinese Clinical Trial Registry (ChiCTR2300073271)

Objectives
Proton pump inhibitor (PPI) exposure can lead to hyponatraemia, which is a common cause of delirium. An association between PPI exposure and delirium without hyponatraemia has been suggested in the literature. We aimed to describe the association between reports of delirium and PPI exposure and to assess the association between PPI and delirium with and without hyponatraemia.

Design
A descriptive and disproportionality analysis of claims data.

Setting
World pharmacovigilance database VigiBase between 1 January 1991 and 9 February 2022.

Primary and secondary outcome measures
In the first part, we described reports of delirium for which involvement of a PPI or interactions of PPIs with other drugs were suspected. In the second part, delirium cases and non-cases were used to assess the disproportionality signal using the reporting OR (ROR) for the associations of PPI exposure with delirium or delirium/hyponatraemia co-events.

Results
We identified 2395 reports of delirium in which involvement of PPI exposure was suspected. Omeprazole, esomeprazole and pantoprazole were the most frequently reported PPIs. Hyponatraemia was present in 11% of the reports. The disproportionality analysis included 1 264 798 reports of adverse drug reactions in patients using PPIs, including 19 081 reports of delirium. We did not find a disproportionality signal for the association between PPI use and delirium (ROR 0.89, 95% CI 0.87 to 0.91). We detected an association of PPI use with delirium/hyponatraemia co-events (ROR 1.53, 95% CI 1.41 to 1.65).

Conclusions
Most reports of delirium in which the involvement of PPIs was suspected did not include concomitant hyponatraemia. However, no significant signal of disproportionate reporting of delirium was observed for PPIs compared with other drugs, except in cases of delirium associated with hyponatraemia. Hyponatraemia may be the main mechanism linking PPI exposure with delirium, and this possibility should be further explored in prospective studies.

Trial registration number
NCT05815550.

Neither haloperidol nor ziprasidone had significant effects on cognitive, functional, quality-of-life, or psychological outcomes.

Introduction
Delirium in neonates and infants is difficult to screen or assess because of their different developmental features and distinct delirium characteristics compared with those of older children. Some delirium management strategies, including assessment, pharmacological and non-pharmacological interventions, and prevention strategies, have been previously suggested for paediatric delirium. However, whether these strategies are effective for delirium in neonates and infants is unclear. This scoping review aims to explore comprehensive information on delirium in neonates and infants, such as the features of delirium, factors related to delirium, and current assessments and interventions in neonates and infants.

Methods and analysis
This study will be based on the Joanna Briggs Institute guidelines for scoping review protocol development and follow each stage of the framework proposed by Arksey and O’Malley. Research questions regarding delirium management in neonates and infants will be specified. A wide range of databases, including MEDLINE, EBSCO, Embase and the Cochrane Library, using optimised terms will be searched from 2004 to 2024. The summarised results will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension of the Scoping Reviews checklist.

Ethics and dissemination
Since this study will review and summarise published scientific literature, ethical approval is not required. The results of this scoping review will be disseminated through conference presentations and peer-reviewed publications. The study findings will be disseminated through seminars for experts so that they can be reflected in practice.