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Delirium clinical trials

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NCT ID: NCT05632159 Recruiting - Clinical trials for Patients Undergoing Lumbar Fixation

Effect of Intraoperative Magnesium Sulphate on the Occurrence of Postoperative Delirium

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

Anaesthesia-related complications and mortality have been significantly reduced in the last years.(1) Nevertheless, anaesthesia-related side effects, such as post-operative delirium and sleep disturbances should not be underestimated. These side effects are economically challenging because they may lead to prolonged hospital stay and change in lifestyle condition. (2) After general anesthesia' sleep disturbances frequently occur. They are featured by insomnia' hyperinsomnia' narcolepsy' and changed sleep structure. (3.4) There are a lot of risk factors associated with post-operative sleep disturbance such as patient age, preoperative comorbidity, severity of surgical trauma, postoperative pain, postoperative complications and presence of pre-operative fatigue and depression. (5) Insomnia is one of the most prevalent health problems during pre-operative period and after post-operative recovery. It can lead to increase incidence of post-operative complications such as delayed recovery , anxiety and delirium (6). Post-operative delirium is also one of the most common complications following anaesthesia with frequency estimates ranging from 10 to 50%. It is defined as delirium occurring 24 to 72 hours after surgery. (7) There are multiple risk factors for developing postoperative delirium including pre-existing dementia, old age, medical co-morbidities, and psycopathological symptoms. The recognition and treatment of Post-operative delirium is critically important because postoperative delirium is associated with poor outcomes including functional decline, dementia, cognitive impairment, increased hospital length of stay , increased mortality ( 11% increasing in the risk of death at 3 months and up to a 17% increased risk of death at 1 year. (8) Animal studies have found that Magnesium can regulate melatonin production which is a hormone that guide body sleep wake cycle (9) . Magnesium is an essential cofactor for many enzymatic reactions' especially those that are involved in energy metabolism and neurotransmitter synthesis. It is a cofactor involved in more than 300 enzyme systems' regulates diverse biochemical reactions in the body (10.11) . Magnesium supplements were used to improve insomnia symptom among older people in a double blinded placebo controlled clinical trial(12). Low dietary Magnesium intake was found to be significantly associated with depression which is a potential risk factor for insomnia(13). Also using Magnesium sulphate as an adjuvant has been associated with significantly less analgesic requirements and reducing postoperative pain which can improve quality of sleep and decrease insomnia symptoms.(14) AIM OF THE STUDY The aim of this work is to identify the potential predictors of postoperative delirium and insomnia in patients undergoing lumbar fixation under general anesthesia, and to evaluate the effect of intraoperative administration of Magnesium sulphate on the occurrence of post-operative delirium and insomnia in those patients.

NCT ID: NCT05630014 Recruiting - Clinical trials for Delirium Superimposed on Dementia

Study of the Aliviado DSD Caregiving Mastery Program

Start date: January 3, 2024
Phase: N/A
Study type: Interventional

Delirium superimposed on dementia (DSD) is an acute and serious condition that is common in persons living with dementia (PLWD). Involvement of family caregivers may aid prevention, early detection, and management of DSD. The purpose of the proposed study is two-fold. First, the investigators will develop a family-centered, mHealth-enhanced DSD caregiving mastery program ("Aliviado DSD Caregiving Mastery Program") through a 5-week co-design workshop with 8 family caregivers (Aim 1). The investigators will adapt/refine the existing clinician-centered DSD contents and an mHealth app from the evidence-based "Aliviado Dementia Care" program for use by family caregivers to support their day-to-day implementation of DSD detection, prevention, and management tasks in the community. Second, the investigators will pilot test the full Aliviado DSD Caregiving Mastery Program with 30 family caregivers of PLWD at high risk for delirium, assessing feasibility, acceptability, app usability, and preliminary program impact (Aim 2).

NCT ID: NCT05628480 Completed - Cardiac Disease Clinical Trials

Multi-omics Analyses Reveal Microbiota-gut-brain Axis in ICU Patients With Post-cardiac Surgery Delirium

Start date: July 1, 2022
Phase:
Study type: Observational

This case-control study is planned to recruit patients who meet the enrollment conditions, receive cardiac surgery (cardiac valve surgery or coronary artery bypass surgery) and cardiopulmonary bypass, and sign the informed consent form in the second ward of adult cardiac surgery, Fuwai Hospital. Use RASS, CAM-ICU scales to evaluate postoperative patients and divide them into delirium and non-delirium groups according to whether they had delirium after surgery. There will be 30 patients in each group. Match the two groups in terms of surgical type, duration of cardiopulmonary bypass, gender and age range (± 3 years). Collect and record the preoperative, intraoperative and postoperative data of the enrolled patients, including cardiopulmonary bypass time, ICU stay time, length of mechanical ventilation, hemodynamics and other data. Fecal and/or blood samples are collected from 60 patients before, immediately after and after operation. The laboratory test and analysis shall be started after the collection of clinical samples. Fecal samples are used for Metagenomics Sequencing and Functional genomics. Blood samples are analyzed by serum metabolomics for changes in intestinal metabolites entering the blood circulation. Simultaneous measurement of IL-6 and TNF in peripheral blood with serum samples- α, IL-1a,IFN-γ and LPS, D-lactic acid and diamine oxidase levels.Use Multi-omics approach to analyze the correlation between intestinal flora diversity, functional gene abundance and blood metabolites, inflammation level and intestinal barrier function, and to find the clinical evidence of the correlation between microbiota-gut-brain axis and the occurrence of POD in patients. Through comprehensive analysis of the research results of this experiment, access to literature, write papers, submit papers and publish relevant papers.

NCT ID: NCT05623475 Recruiting - Delirium Clinical Trials

Effects of Scenario-based Education Initiative and OSCE for Recognition and Management of Delirium

Start date: October 25, 2021
Phase: N/A
Study type: Interventional

Delirium is a disturbance in consciousness with reduced ability to focus, sustain, or shift attention that occurs over a short period of time and tends to fluctuate over the course of the day. 50% to 81.7% had delirium during their ICU hospitalization. Delirium is associated with increased physical restraint, ventilation use, length of ICU stay, and mortality. However, there is no established delirium care pathway in target hospital. Chen et al. (2014) demonstrated that structured assessment stations with immediate feedback may improve overall learning efficiency over an EBP workshop alone. However, no published delirium care education study has used OSCEs as an intervention for healthcare professionals. The aim is to evaluate the effects of implementing a Scenario- based education intervention, including objective structured clinical examinations (OSCEs) on delirium care among healthcare professionals. This is a knowledge translation research, builds on eight years of delirium care research in University of Wollongong, Australia. The research will be undertaken at ICUs in a medical center in northern of Taiwan. There are two phases: (1) systematic review to identify delirium screen tool, and (2) a randomized controlled trial was conducted to determine the effects of implementing a Scenario-based education intervention, including OSCE (experimental group), and on-line education only (control group) focused on recognition and management of delirium. The hypothesis is: Scenario-based education intervention, including OSCE can increase the competence and self-efficacy among healthcare professionals in delirium care.

NCT ID: NCT05606328 Active, not recruiting - Delirium Clinical Trials

Implementation Outcome Assessments of the Emergency Department Delirium Screening and Detection Program

ED-DDP
Start date: February 28, 2023
Phase: N/A
Study type: Interventional

Delirium occurs in up to 20% of older adults presenting to the Emergency Department (ED) and is associated with poor outcomes. Failure to identify patients with ED delirium not only prevents initiation of mitigation strategies, but is also a barrier to advancing the field in terms of evaluating management and clinical outcomes. This project studies the potential of an ED Delirium Detection Program (ED-DDP), developed to address the need for consistent and accurate ED delirium detection. This research will have two objectives: - Aim 1 will conduct a pilot stepped wedge cluster randomized trial (SW-CRT) of the ED-DDP across 3 diverse EDs to determine preliminary efficacy of the detection training program, and - Aim 2 will use a mixed methods approach to assess RE-AIM implementation outcomes (Reach, Efficacy, Adoption, Implementation, and Maintenance) of the training program. Aim 1 will consist of a multicomponent 1-day delirium champion workshop where the training is delivered, real-time direct observation/training of champions via telehealth, practical training of nurses throughout each ED by champions, and patient chart review. In Aim 2, the investigators will assess implementation outcomes using training logs, tele-observation, interviews with champions and nurses, and electronic medical record screening. The overarching aim of this proposal is to determine the preliminary efficacy of the training program for improving ED delirium screening, detection, and management in older adults, while also evaluating implementation outcomes of the program for champions/nurses. The investigators will use findings from this study to inform a full-scale SW-CRT to evaluate the impact of the program on patient outcomes at Northwell Health. The long-term goal of this study is to implement and disseminate a comprehensive ED-DDP that will improve screening, detection, and management of ED delirium in older adults.

NCT ID: NCT05596071 Completed - Clinical trials for Postoperative Delirium

Whether Opioids Are Factor That Induced POD?

POD
Start date: June 25, 2016
Phase: N/A
Study type: Interventional

The purpose of this study was to investigate whether perioperative use of low doses of opioids could reduce postoperative delirium .

NCT ID: NCT05595954 Recruiting - Clinical trials for Postoperative Delirium

Impact of Personalised Cardiac Anaesthesia and Cerebral Autoregulation on Neurological Outcomes in Patients Undergoing Cardiac Surgery

PRECISION
Start date: January 23, 2023
Phase:
Study type: Observational

This international, multicentre prospective cohort study will assess whether perioperative duration and magnitude of mean arterial pressure (MAP) outside of an individual's cerebral autoregulation (CA) limits using near-infrared spectroscopy (NIRS) and transcranial Doppler (TCD) are associated with adverse neurological events. It is to investigate whether patients with a higher burden of cerebral haemodynamic insults have an increased incidence or poorer neurological outcomes. Associations between neurologic outcomes, neurobiomarkers and genetic tests will be explored.

NCT ID: NCT05594966 Not yet recruiting - Clinical trials for Postoperative Delirium

Neuroimaging Combining Biomarkers for Identifying Long-term Cognitive Dysfunction and Delirium

NeuroIDEA
Start date: November 2022
Phase:
Study type: Observational

Postoperative Cognitive Dysfunction(POCD) is commonly seen in cardiac surgery, which may lead to poor pognosis. Cerebral small vessel disease(CVSD) is refer as the main resource of delirium among elderly people. In the study, CVSD will be diagnosed using multimodal MRI. And we want to select a high correlating COPD biomarker through CyTOF. We also want to investigate a medical model to select the high risk patients who may suffer from POCD after cardiac surgery.

NCT ID: NCT05582005 Not yet recruiting - Pain Clinical Trials

An Observational Study of Emergence and Hypoactive Delirium After Anesthesia

Start date: December 2022
Phase:
Study type: Observational

Early postoperative negative behaviour (ePONB), such as pain, emergence delirium (ED) and hypoactive delirium, is a relevant clinical problem during recovery from anesthesia. Specifically, many children often present with different forms of negative behavior namely ED, hypoactive delirium or pain. Such negative behavior differs in terms of evolution, treatment, prognosis and clinical implications. Furthermore, there is overlap between tools used to measurement postoperative pain and ED. As a result, the assessment of the different forms of negative behavior are often compromised by the presence of postoperative pain. Therefore, the application of scales used to measure negative behaviour in postanesthetic, non-surgical patients aged 3 years and under scheduled for elective MRI may clarify the presence of ED, hypoactive delirium and pain. An improved understating of postanesthetic negative behavior is important in order to help implement appropriate measures so as to better treat these patients.

NCT ID: NCT05579093 Completed - Delirium Clinical Trials

Clinical Investigation of an Eye-Tracking Device as a Predictor of Delirium in the Recovery Room After Surgery With General Anesthesia

Start date: October 1, 2019
Phase:
Study type: Observational

Neurotrack™ is an FDA-approved device for measuring and tracking cognitive decline, as may occur with age-related cognitive decline and Alzheimer's disease. The device uses a webcam (World Wide Web enabled camera) to assess eye-tracking as the subject views black-and-white images on the computer screen. The test takes less than 5 minutes to complete. This study will examine the feasibility and utility of pre-operative assessment of cognition using Neurotrack™ technology. The predictive value of Neurotrack™ will be compared to our previous work using pupillometry. The primary outcome is a measure of delirium in the recovery room and secondary outcomes include total length of stay, intensive care unit (ICU) length of stay, and readmissions within 30 days of surgery.