Search Results for: Il delirium

Objective
This study aims to determine the frequency of falls and their serious complications in palliative care units (PCUs), as well as explore the complex interplay between falls, independence and quality of dying.

Design
A prospective cohort study.

Setting and participants
The dying process of patients with advanced cancer in 23 PCUs in Japan.

Outcome measures
Palliative care specialist physicians recorded whether patients experienced falls, serious complications from falls, activities that led to falls, independence (workability in the last days and use of indwelling urinary catheter) and Good Death Scale as an indicator of quality of dying.

Results
Of the 1633 patients evaluated, 150 patients (9.2%; 95% CI 7.8% to 11%) experienced falls within 30 days prior to death. The patients who fell were mostly men, had Eastern Cooperative Oncology Group performance status 3 on admission, a longer estimated prognosis on admission and delirium during hospitalisation. Serious falls causing fractures or intracranial haemorrhages were rare in five patients (0.3%; 95% CI 0.038% to 0.57%). The most common reason for falls was the need to use the toilet (64.7%). The Good Death Scale and indwelling urinary catheter use were not significantly associated with falls (p=0.34; p=0.34).

Conclusion
Falls occur in approximately 10% of patients in PCUs, but serious complications are rare. The relationship between falls, independence and quality of dying is complex, that is, a fall may not be necessarily bad, if it is the result of respect for the patient’s independence. Healthcare providers need to consider fall prevention while supporting patients’ desire to move on their own to maintain independence.

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
Selective posterior rhizotomy (SPR) is a preferred procedure for relieving spastic children with cerebral palsy, but it is associated with severe pain and significant emergence agitation (EA). The thoracolumbar interfascial plane (TLIP) block provides an effective blockade to the dorsal branch of the spinal nerve. We hypothesise that the TLIP block may be an effective tool to alleviate EA and postoperative pain scores in children with cerebral palsy undergoing SPR.

Methods and analysis
This study is a single-centre, randomised, parallel-controlled trial being conducted in Beijing, China. A total of 50 paediatric patients with cerebral palsy scheduled for SPR are randomised in a 1:1 ratio to receive bilateral TLIP block with 0.2% ropivacaine 0.5 mL/kg or control. Patients in the TLIP group receive general anaesthesia combined with TLIP block, while patients in the control group receive only general anaesthesia, without a TLIP block. The primary outcome is the Paediatric Anaesthesia Emergence Delirium Score. The secondary outcomes are the incidence of EA, the Wong-Baker Faces Pain-rating Scale, the perioperative haemodynamics, the intraoperative remifentanil and propofol dosage, the extubation time and recovery time, and adverse reactions.

Ethics and dissemination
This study was approved by the Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine on 21 September 2023 (2023DZMEC-379–02). Written informed consent is obtained from the legal guardian of each patient. The results of this study will be published in peer-reviewed international journals.

Trial registration number
ChiCTR2300076397

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.

In this issue of JAMA, Deschamps and colleagues report results of the Electroencephalographic Guidance of Anesthesia to Alleviate Geriatric Syndromes-Canada (ENGAGES-Canada) trial. ENGAGES-Canada compared rates of postoperative delirium among 1140 patients 60 years or older undergoing cardiac surgery who were randomly assigned to 1 of 2 strategies to prevent excessive dosing of inhaled general anesthetics: electroencephalogram (EEG)-guided dosing vs usual care, in which anesthesia dose was guided by expired anesthesia gas levels and hemodynamic measurements. Although some previous studies have found an association between deep general anesthesia and postoperative delirium, it remains unknown whether using EEG guidance to minimize time with intraoperative EEG suppression—a marker of deep anesthesia—might reduce delirium compared with usual care.

This randomized clinical trial examines whether electroencephalogram -guided anesthesia decreases the incidence of delirium after cardiac surgery among adults 60 years or older.

Background
Hospital electronic patient records (EPRs) offer the opportunity to exploit large-scale routinely acquired data at relatively low cost and without selection. EPRs provide considerably richer data, and in real-time, than retrospective administrative data sets in which clinical complexity is often poorly captured. With population ageing, a wide range of hospital specialties now manage older people with multimorbidity, frailty and associated poor outcomes. We, therefore, set-up the Oxford and Reading Cognitive Comorbidity, Frailty and Ageing Research Database-Electronic Patient Records (ORCHARD-EPR) to facilitate clinically meaningful research in older hospital patients, including algorithm development, and to aid medical decision-making, implementation of guidelines, and inform policy.

Methods and analysis
ORCHARD-EPR uses routinely acquired individual patient data on all patients aged ≥65 years with unplanned admission or Same Day Emergency Care unit attendance at four acute general hospitals serving a population of >800 000 (Oxfordshire, UK) with planned extension to the neighbouring Berkshire regional hospitals ( >1 000 000). Data fields include diagnosis, comorbidities, nursing risk assessments, frailty, observations, illness acuity, laboratory tests and brain scan images. Importantly, ORCHARD-EPR contains the results from mandatory hospital-wide cognitive screening (≥70 years) comprising the 10-point Abbreviated-Mental-Test and dementia and delirium diagnosis (Confusion Assessment Method—CAM). Outcomes include length of stay, delayed transfers of care, discharge destination, readmissions and death. The rich multimodal data are further enhanced by linkage to secondary care electronic mental health records. Selection of appropriate subgroups or linkage to existing cohorts allows disease-specific studies. Over 200 000 patient episodes are included to date with data collection ongoing of which 129 248 are admissions with a length of stay ≥1 day in 64 641 unique patients.

Ethics and dissemination
ORCHARD-EPR is approved by the South Central Oxford C Research Ethics Committee (ref: 23/SC/0258). Results will be widely disseminated through peer-reviewed publications and presentations at conferences, and regional meetings to improve hospital data quality and clinical services.

Introduction
Surgical patients over 70 experience postoperative delirium (POD) complications in up to 50% of procedures. Sleep/circadian disruption has emerged as a potential risk factor for POD in epidemiological studies. This protocol presents a single-site, prospective observational study designed to examine the relationship between sleep/circadian regulation and POD and how this association could be moderated or mediated by Alzheimer’s disease (AD) pathology and genetic risk for AD.

Methods and analysis
Study staff members will screen for eligible patients (age ≥70) seeking joint replacement or spinal surgery at Massachusetts General Hospital (MGH). At the inclusion visit, patients will be asked a series of questionnaires related to sleep and cognition, conduct a four-lead ECG recording and be fitted for an actigraphy watch to wear for 7 days before surgery. Blood samples will be collected preoperatively and postoperatively and will be used to gather information about AD variant genes (APOE-4) and AD-related pathology (total and phosphorylated tau). Confusion Assessment Method-Scale and Montreal Cognitive Assessment will be completed twice daily for 3 days after surgery. Seven-day actigraphy assessments and Patient-Reported Outcomes Measurement Information System questionnaires will be performed 1, 3 and 12 months after surgery. Relevant patient clinical data will be monitored and recorded throughout the study.

Ethics and dissemination
This study is approved by the IRB at MGH, Boston, and it is registered with the US National Institutes of Health on ClinicalTrials.gov (NCT06052397). Plans for dissemination include conference presentations at a variety of scientific institutions. Results from this study are intended to be published in peer-reviewed journals. Relevant updates will be made available on ClinicalTrials.gov.

Trial registration number
NCT06052397.

Introduction
Physical restraint (PR) is prescribed in patients receiving invasive mechanical ventilation in the intensive care unit (ICU) to avoid unplanned removal of medical devices. However, it is associated with an increased risk of delirium. We hypothesise that a restrictive use of PR, as compared with a systematic use, could reduce the duration of delirium in ICU patients receiving invasive mechanical ventilation.

Methods and analysis
The Restrictive use of Restraints and Delirium Duration in ICU (R2D2-ICU) study is a national multicentric, parallel-group, randomised (1:1) open-label, controlled, superiority trial, which will be conducted in 10 ICUs. A total of 422 adult patients requiring invasive mechanical ventilation for an expected duration of at least 48 hours and eligible for prescription of PR will be randomly allocated within 6 hours from intubation to either the restrictive PR use group or the systematic PR use group, until day 14, ICU discharge or death, whichever comes first. In both groups, PR will consist of the use of wrist straps. The primary endpoint will be delirium or coma-free days, defined as the number of days spent alive in the ICU without coma or delirium within the first 14 days after randomisation. Delirium will be assessed using the Confusion Assessment Method-ICU twice daily. Key secondary endpoints will encompass agitation episodes, opioid, propofol, benzodiazepine and antipsychotic drug exposure during the 14-day intervention period, along with a core outcome set of measures evaluated 90 days postrandomisation.

Ethics and dissemination
The R2D2-ICU study has been approved by the Comité de Protection des Personnes (CPP) ILE DE FRANCE III—PARIS (CPP19.09.06.37521) on June 10th, 2019). Participant recruitment started on 25 January 2021. Results will be published in international peer-reviewed medical journals and presented at conferences.

Trial registration number
NCT04273360.

The effect persists for years and is dose-dependent, suggesting a causal relation.

Introduction
An association between deep sedation and adverse short-term outcomes has been demonstrated although this evidence has been inconsistent. The A2B (alpha-2 agonists for sedation in critical care) sedation trial is designed to determine whether the alpha-2 agonists clonidine and dexmedetomidine, compared with usual care, are clinically and cost-effective. The A2B intervention is a complex intervention conducted in 39 intensive care units (ICUs) in the UK. Multicentre organisational factors, variable cultures, perceptions and practices and the involvement of multiple members of the healthcare team add to the complexity of the A2B trial. From our pretrial contextual exploration it was apparent that routine practices such as type and frequency of pain, agitation and delirium assessment, as well as the common sedative agents used, varied widely across the UK. Anticipated challenges in implementing A2B focused on the impact of usual practice, perceptions of risk, ICU culture, structure and the presence of equipoise. Given this complexity, a process evaluation has been embedded in the A2B trial to uncover factors that could impact successful delivery and explore their impact on intervention delivery and interpretation of outcomes.

Methods and analysis
This is a mixed-methods process evaluation guided by the A2B intervention logic model. It includes two phases of data collection conducted during and at the end of trial. Data will be collected using a combination of questionnaires, stakeholder interviews and routinely collected trial data. A framework approach will be used to analyse qualitative data with synthesis of data within and across the phases. The nature of the relationship between delivery of the A2B intervention and the trial primary and secondary outcomes will be explored.

Ethics and dissemination
All elements of the A2B trial, including the process evaluation, are approved by Scotland A Research Ethics Committee (Ref. 18/SS/0085). Dissemination will be via publications, presentations and media engagement.

Trial registration number
NCT03653832.

Introduction
Preoperative anxiety and depression symptoms among older surgical patients are associated with poor postoperative outcomes, yet evidence-based interventions for anxiety and depression have not been applied within this setting. We present a protocol for randomised controlled trials (RCTs) in three surgical cohorts: cardiac, oncological and orthopaedic, investigating whether a perioperative mental health intervention, with psychological and pharmacological components, reduces perioperative symptoms of depression and anxiety in older surgical patients.

Methods and analysis
Adults ≥60 years undergoing cardiac, orthopaedic or oncological surgery will be enrolled in one of three-linked type 1 hybrid effectiveness/implementation RCTs that will be conducted in tandem with similar methods. In each trial, 100 participants will be randomised to a remotely delivered perioperative behavioural treatment incorporating principles of behavioural activation, compassion and care coordination, and medication optimisation, or enhanced usual care with mental health-related resources for this population. The primary outcome is change in depression and anxiety symptoms assessed with the Patient Health Questionnaire-Anxiety Depression Scale from baseline to 3 months post surgery. Other outcomes include quality of life, delirium, length of stay, falls, rehospitalisation, pain and implementation outcomes, including study and intervention reach, acceptability, feasibility and appropriateness, and patient experience with the intervention.

Ethics and dissemination
The trials have received ethics approval from the Washington University School of Medicine Institutional Review Board. Informed consent is required for participation in the trials. The results will be submitted for publication in peer-reviewed journals, presented at clinical research conferences and disseminated via the Center for Perioperative Mental Health website.

Trial registration numbers
NCT05575128, NCT05685511, NCT05697835, pre-results.

Objectives
Delirium is a form of brain dysfunction with high incidence and is associated with many negative outcomes in the intensive care unit. However, few studies have been large enough to reliably examine the associations between body mass index (BMI) and delirium, especially in critically ill patients. The objective of this study was to investigate the association between BMI and delirium incidence in critically ill patients.

Design
A retrospective cohort study.

Setting
Data were collected from the Medical Information Mart for Intensive Care-IV V2.0 Database consisting of critically ill participants between 2008 and 2019 at the Beth Israel Deaconess Medical Center in Boston.

Participants
A total of 20 193 patients with BMI and delirium records were enrolled in this study and were divided into six groups.

Primary outcome measure
Delirium incidence.

Results
Generalised linear models and restricted cubic spline analysis were used to estimate the associations between BMI and delirium incidence. A total of 30.81% of the patients (6222 of 20 193) developed delirium in the total cohort. Compared with those in the healthy weight group, the patients in the different groups (underweight, overweight, obesity grade 1, obesity grade 2, obesity grade 3) had different relative risks (RRs): RR=1.10, 95% CI=1.02 to 1.19, p=0.011; RR=0.93, 95% CI=0.88 to 0.97, p=0.003; RR=0.88, 95% CI=0.83 to 0.94, p