Prevalence of delirium in German nursing homes: protocol for a cross-sectional study

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).

Leggi
Gennaio 2025

Effectiveness of a virtual reality-based sensory stimulation intervention in preventing delirium in intensive care units: a randomised-controlled trial protocol

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.

Leggi
Gennaio 2025

Effects of head direction during prone position on postoperative delirium in elderly patients undergoing thoracolumbar spine surgery: a study protocol for a randomised controlled trial

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.

Leggi
Dicembre 2024