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Delirium clinical trials

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NCT ID: NCT03293927 Withdrawn - Delirium Clinical Trials

Polypharmacy-related Adverse Events in Critically Ill Children

Start date: April 9, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to learn how 2 medications (fentanyl and dexmedetomidine) affect how sick children think and interact with their environments.

NCT ID: NCT03293550 Completed - Delirium Clinical Trials

Can a New EEG Based Tool Predict Post-operative Delirium and Cognitive Dysfunction?

Start date: December 31, 2017
Phase:
Study type: Observational

As the population ages and medical progress is made, many elderly patients that previously would not have been candidates for surgery are now undergoing operations. In this group of older patients, brain dysfunction after anesthesia and surgery is well recognized and categorized into two distinct clinical entities; Post-operative cognitive delirium (POD) and post-operative cognitive dysfunction (POCD). Delirium is an acute and fluctuating deterioration in attention accompanied by either a change in cognition or arousal and is often diagnosed by criteria established in the Confusion Assessment Method (CAM). Delirium can present as hypoactive (decreased alertness, motor activity and anhedonia), as hyperactive (agitated and combative) or as mixed forms. Age and the type of operation are the major risk factors. Post-operative cognitive dysfunction (POCD) is a term used to describe subtle changes in cognition, such as memory and executive function. The most commonly seen problems are memory impairment and impaired performance on intellectual tasks. In severe cases, it can lead to inability to perform daily living functions. It was previously found that the presence of cognitive dysfunction 3 months after non-cardiac surgery was associated with an increased mortality. The mechanisms leading to cognitive impairment after anesthesia and surgery are not yet fully clear. The risk factors are related to patient characteristics, type of operation and anesthetic management. Despite its limitations over-anesthesia as monitored by BIS was at-least correlative with POD. Therefore it is hopeful that an even more precise evaluation of the level of anesthesia will improve POD prediction (and thereby prevention) even further. On the other hand the measure of depth of anesthesia by itself does not provide sufficient prediction for POCD. In POCD a major role has been assigned to hippocampal damage. The investigators have recently demonstrated that temporary hippocampal interruptions are manifested by interhemispheric desynchronization, which are recognized by our new algorithm, which monitors electrophysiological markers of attention and of perception. The investigators have developed a unique algorithm for analyzing EEG based on the concept of monitoring perception and attention and their interhemispheric synchronization. The aims of this proof of concept study are: (i) to find-out whether interhemispheric desynchronization of attentional processes is associated with POCD; (ii) to find out whether the level of anesthesia, is linked primary to POD and secondary to POCD.

NCT ID: NCT03291626 Active, not recruiting - Clinical trials for Postoperative Delirium

Postoperative Delirium: EEG Markers of Sleep and Wakefulness

Start date: October 16, 2018
Phase:
Study type: Observational

Postoperative delirium is a condition in which patients develop temporary difficulties in maintaining attention and thinking clearly. These new problems can appear after surgery and change throughout the day. This confusion can last several days. The overall purpose of this study is to measure brain activity during sleep and wakefulness to learn about their relationships to delirium after surgery. While participants may not feel like their normal self during the study, they are in the best position to help us learn how to improve the recovery of brain function and sleep in others having surgery. The investigators need to learn from those who have and have not become confused after their surgical procedure.

NCT ID: NCT03287401 Completed - Delirium Clinical Trials

Prediction of PACU Delirium Using EEG - German Validation Study

PACUD-EEG
Start date: September 19, 2017
Phase:
Study type: Observational

Aim of this observational study is to investigate whether frontal electroencephalogram analysis is able to predict increased risk for PACU delirium.

NCT ID: NCT03285243 Completed - Emergence Delirium Clinical Trials

Effect of Monochromatic Light on Incidence of Emergence Delirium in Children

Start date: November 3, 2017
Phase: N/A
Study type: Interventional

Emergence delirium/emergence agitation (ED/EA) is a behavioral phenomenon of unclear etiology consisting of short lived behavioral changes that can be both traumatic to families and pose a safety risk to patients and staff. ED is characterized by a variety of presentations, including crying, excitation and agitation, that occur during the early stage of recovery from general anesthesia, generally in the first 30 minutes. Emergence delirium occurs in children of all ages following an anesthetic with halogenated agents (e.g. sevoflurane/isoflurane) with or without having undergone a surgical procedure (e.g. MRI patients). Presently, the treatment for ED is to revert the patient back to a hypnotic state mainly with sedatives so that they may "reset" themselves postulating that by re-inducing a hypnotic state, the brain has time to resolve this issue. The hypothesis of this study is that during ED, there is failure of organized EEG activity, especially alpha wave activity and that by enhancing alpha activity, the incidence of ED may be reduced without the need for additional pharmaceuticals which may be costly, delay recovery and are not without adverse effects specifically cardiopulmonary depression through the use of blue monochromatic light.

NCT ID: NCT03284437 Withdrawn - Clinical trials for Intensive Care Units, Delirium, Cognitive Dysfunction

Pilot Study of Early Cognitive Training in the Intensive Care Unit

ECTICU
Start date: January 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to see how early cognitive training (participation/involvement in activities to stimulate the brain) in the Intensive Care Unit (ICU) affects the number of patients who experience delirium (confusion) and cognitive impairment (problems with thinking). Reports have shown that 30% to 80% of all ICU patients will have some type of cognitive impairment: remembering, paying attention, solving problems, organizing, and working on complex tasks for some time after they leave the hospital. Occupational therapy will do an assessment after an order is received from the doctor. The patient will be randomly placed into one of two groups. If the patient is in group A then they will continue with occupational therapy as normal. If the patient is assigned to group B then they and the family will have access to an activity cart found there in the ICU unit, directed by the nurses. The family will work with the patient on a daily basis to complete activities that are appropriate for the patient based on the occupational therapist's assessment. All patients in the study will receive medical care as usual. Information about the patient's recovery in the hospital will be collected. In addition, patients and/or their family member will complete surveys at 6 months and 1 year after enrollment to see how they have recovered and if there are continuing issues. The two groups of patients, those who received the early cognitive training and those who did not, will be compared statistically to see if there are any differences in how well they recovered. Since this intervention involving family members working with the patient has not previously been evaluated, the study will also examine the feasibility of conducting these activities in the ICU setting.

NCT ID: NCT03277118 Completed - Sleep Clinical Trials

Quantifying Activity Using Wireless Wearable Technology

Start date: April 18, 2017
Phase:
Study type: Observational

Wireless wearable devices (WWD) have been shown to be an effective means to measure patient activity and sleep-wake cycles in the ICU. However, no current studies involving WWD have demonstrated the ability of these devices to measure adverse outcomes, including delirium in critically ill patients. This study is unique because the investigators will implement monitoring with the WWD prior to extubation in the ICU to correctly measure first mobilization, as well as capture quality of sleep and episodes of delirium for the first five postoperative days.

NCT ID: NCT03273335 Completed - Delirium Clinical Trials

Investigating NeuroinflammaTion UnderlyIng Postoperative Brain Connectivity Changes, POCD, Delirium in Older Adults

INTUIT
Start date: June 15, 2017
Phase:
Study type: Observational

(From NIH reporter) Each year >16 million older Americans undergo anesthesia and surgery, and up to 40% of these patients develop postoperative cognitive dysfunction (POCD), a syndrome of postoperative thinking and memory deficits. Although distinct from delirium, POCD (like delirium) is associated with decreased quality of life, long term cognitive decline, early retirement, increased mortality, and a possible increased risk for developing dementia such as Alzheimer's disease. Understanding the etiology of POCD will likely help promote strategies to treat and/or prevent it. A dominant theory holds that brain inflammation causes POCD, but little work has directly tested this theory in humans. The preliminary data of this team strongly suggest that there is significant postoperative neuro-inflammation in older adults who develop POCD. In this K76 award, the investigators will prospectively obtain pre- and post-operative cognitive testing, fMRI imaging and CSF samples in 200 surgical patients over age 65. This will allow the investigators to evaluate the role of specific neuro-inflammatory processes in POCD and its underlying brain connectivity changes.

NCT ID: NCT03263442 Completed - Delirium Clinical Trials

High Dose Intravenous Thiamine for the Prevention of Delirium in Allogeneic Hematopoietic Stem Cell Transplantation

Start date: October 16, 2017
Phase: Phase 2
Study type: Interventional

Purpose: To conduct a randomized controlled pilot study investigating the use of high dose intravenous (IV) thiamine to prevent delirium and mitigate the long-term effects of delirium, including health-related quality of life (HRQOL), functional status, and neuropsychiatric outcomes, in patients admitted to University of North Carolina (UNC) Hospital for allogeneic hematopoietic stem cell transplant (HSCT). Participants: 60 adult inpatients admitted to the UNC Bone Marrow Transplant Unit for allogeneic stem cell transplant. Procedures (methods): Participants will be admitted for allogeneic HSCT and on the day after transplant randomized to seven days of high dose IV thiamine or placebo. Thiamine levels will be measured weekly and participants will be assessed for evidence of delirium using validated measures. Validated measures will also be used to assess cognitive function, depression, post-traumatic stress symptoms, functional status, and HRQOL prior to hospitalization and at one, three, and six months after transplant.

NCT ID: NCT03260218 Recruiting - Clinical trials for Postoperative Delirium

Protocol for Observational Study of Post op Delirium Following Total Joint Arthroplasties

Start date: July 3, 2017
Phase: N/A
Study type: Observational

The incidence of post-operative delirium in the South-east Asian population is not known. Through a prospective, single centre, observational study, the investigators aim to characterize the incidence and risk factors of delirium in older adults undergoing elective total joint arthroplasties (TJA). The study will recruit eligible patients (65 - 90 years old undergoing elective TJA), with a targeted sample size of 500. Patients will be screened for dementia and Confusion Assessment Method (CAM) scores obtained pre and post operatively. Other data such as preoperative Charlson comorbidity index (CCI), post op complications using Post operative Morbidity Survey (POMS), pain scores, readmission rates and length of hospital stay (LOS), functional and health-related quality-of-life (HRQoL) will also be collected and analysed.