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Delirium clinical trials

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NCT ID: NCT04841122 Terminated - Delirium Clinical Trials

Improved Patient Safety for Acute Restless Medical Patients With Supplemental Observation

Start date: April 19, 2021
Phase: N/A
Study type: Interventional

The aim of the study is to investigate whether supplemental camera observation directly linked to the nurse's phone will improve patient safety for acute medical care patients', who are restless, confused or in risk of development of acute delirium. The setting is an acute medical care ward. The expected result is a reduced incidence of patients with delirious condition, patients who fall or unintentionally remove intravenous access or catheters. Thus, higher patient safety and more efficient patient trajectories are expected, as well as a reduced need for treatment, care and rehabilitation after discharge.

NCT ID: NCT04246892 Terminated - Delirium Clinical Trials

Impact of Alarm Reduction on Delirium in ICU

ALADIN
Start date: February 3, 2020
Phase:
Study type: Observational [Patient Registry]

Delirium is an acute and fluctuating disturbance of consciousness and can occur in 80% of critically ill patients. Delirium is more frequent in mecanically ventilated patients and is associated with longer hospital stay, increased cognitive impairment and mortality. On the occasion of the change of the monitors in the ICU ward, allowing a total withdrawal of alarms in patients room, this study evaluates the prevalence of delirium before and after the alarm withdrawal. During the first period the patients will be monitored as usual, and during the second period patients will be monitored without alarms ringing in patients room. Delirium will be screened with a validated, clinical tool.

NCT ID: NCT03941119 Terminated - Dementia Clinical Trials

Evaluating the Impact of VR-therapy on BPSD and QoL of Individuals With Dementia Admitted to Hospital

VRx-RCT
Start date: May 6, 2019
Phase: N/A
Study type: Interventional

Behavioural and Psychological Symptoms of Dementia (BPSD) (such as aggression, restlessness, agitation, wandering, anxiety, depression) are common to most people with dementia at some point during their illness and represent an aspect of dementia particularly difficult to manage. There is growing attention to the therapeutic effects of natural environments on people's health. Exposure to natural environments (seeing greenery, hearing outside natural sounds) has been shown to enhance wellbeing, reduce depression, anxiety and stress levels, and decrease hospital length-of-stay for inpatients. Virtual Reality (VR) is a novel technology that uses a Head Mounted Display (HMD) to generate simulated immersive experiences that elicit perceptions and behaviors similar to those in real life and can make one feel as though they are truly present in another place. Based on scientific research, previous studies, and expert consultation, we created a library of VR experiences depicting calming nature scenes designed specifically for people with dementia. The objectives of this RCT are 1) to evaluate the effects of VR-therapy on BPSD and the hospital care experience of in-patients with dementia and/or delirium admitted to an acute care hospital, 2) to determine the usability, tolerability, and safety of VR-therapy for patients with dementia and/or delirium admitted to acute care, 3) determine the effect of VR-therapy on quality of life for patients with dementia and/or delirium admitted to acute care and 4) to explore a framework for introducing non-pharmacological therapies in acute care hospitals. Our hypotheses are 1) VR-therapy helps manage BPSD (e.g. decrease anxiety, aggression, depression, violent behaviors, incidents of wandering), and may decrease the amount and/or frequency of sedatives and anti-depressant medication administered and/or the number of incidents that require restraints, and the number of falls, in people with dementia and/or delirium admitted to an acute care hospital. 2) VR-therapy will improve the quality of life for individuals with dementia and/or delirium admitted to an acute care hospital (operationalized through conducting a validated instrument to measure quality of life for people with dementia). 3) VR-therapy is safe and feasible to administer to individuals with dementia and/or delirium admitted to an acute care hospital (with assistance from their circle of care members and/or caregivers).

NCT ID: NCT03901976 Terminated - Clinical trials for Delirium of Mixed Origin

ZeroFall - Reliability Testing of Optical Sensor to Detect Bed Exit for Patients in Hospital

Start date: March 25, 2019
Phase: N/A
Study type: Interventional

Falls are one of the most common NHS adverse events. With an increasing number of frail elderly patients being admitted this risk is likely to increase. In order to be able to assist patients with bed exit in a timely manner monitoring might be of help. In ZeroFall we will test the reliability of monitoring devices to notify care givers if a patient is attempting to exit the bed.

NCT ID: NCT03739476 Terminated - Clinical trials for Postoperative Delirium

Clinical Trial With Quetiapine Prophylaxis Postoperative Delirium in High Risk Surgical Patients

Start date: February 13, 2019
Phase: Phase 3
Study type: Interventional

Double blinded Clinical trial to test efficacy of Quetiapine versus placebo in reducing postoperative delirium in high risk surgical patients after three days of treatment.

NCT ID: NCT03735940 Terminated - Delirium Clinical Trials

Clinical Evaluation Program of DeltaScan (ICU)

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Rationale: Delirium, or acute brain failure, presents as an acute confusional state, and is associated with prolonged hospitalization, an increased risk of dementia, institutionalization and mortality, as well as increased costs. Early detection of delirium would allow for early treatment and improved patient outcomes, but delirium is often not recognized and treatment is therefore delayed or not applied at all. Additionally, current screening tools are subjective, so an alternative, more objective diagnostic tool for early delirium detection is desired. The DeltaScan, a CE-certified device to detect delirium using brief EEG recording, has been recently been found have diagnostic properties that outperform the currently used screening tools. Objective: To quantify the impact of the use of the DeltaScan on patient outcome (detection rate of delirium and duration of admission) in patients with high risk of delirium compared to the currently used delirium screening tools. Study design: A prospective multicenter stepped wedge cluster randomized trials in (at least) 4 ICU departments. Study population: Adult patients admitted to an intensive care unit (ICU) with high risk of delirium. Intervention: During 12 months, patients presenting at the ICU of participating hospitals with an expected stay > 1 day will be included in the study. First, all hospitals will apply 'usual care' to all patients, i.e. standard delirium screening (e.g. the Confusion Assessment Method (CAM)-ICU) or other currently used tools) in combination with a delirium treatment protocol and subsequent management without application of the DeltaScan for a period of 3 months. Then, during a 6 month period, each 2 months, starting at day 0, randomly allocated hospitals will sequentially start to apply the DeltaScan in all eligible patients (intervention period). During the last 3 months of the study all hospitals will participate in the intervention period. Main study endpoints: Primary endpoints: delirium detection rate (i.e. proportion of positive assessments according to the delirium detection tool), and duration of admission at ICU. Secondary endpoints: time interval between admission and the first delirium positive assessment, number of days with at least one positive delirium assessment, delirium incidence, hospital mortality, and direct medical costs of hospitalization. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: During the intervention period EEG recordings using the CE-certified DeltaScan will be made using a strip with EEG electrodes that will be mounted to the head using self-adhesive gel. The EEG recording will be performed two to three times daily and takes 3-4 minutes. During the usual care period the patients will receive the standard delirium screening tool for delirium assessment by a nurse. This assessment will be performed two to three times daily and takes 2-4 minutes depending on the screening tools that is used. Since the DeltaScan has shown to have superior diagnostic performance compared to the DSM5 the burden/risk of misclassification is lower than with the current standard for delirium assessment. Based on the above we consider the burden to participants in this study to be minimal.

NCT ID: NCT03735927 Terminated - Delirium Clinical Trials

Clinical Evaluation Program of DeltaScan (Ward)

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Rationale: Delirium, or acute brain failure, presents as an acute confusional state, and is associated with prolonged hospitalization, an increased risk of dementia, institutionalization and mortality, as well as increased costs. Early detection of delirium would allow for early treatment and improved patient outcomes, but delirium is often not recognized and treatment is therefore delayed or not applied at all. Additionally, current screening tools are subjective, so an alternative, more objective diagnostic tool for early delirium detection is desired. The DeltaScan, a CE-certified device to detect delirium using brief EEG recording, has been recently been found have diagnostic properties that outperform the currently used screening tools. Objective: To quantify the impact of the use of the DeltaScan on patient outcome (detection rate of delirium and duration of admission) in patients with high risk of delirium compared to the currently used delirium screening tools. Study design: A prospective multicenter stepped wedge cluster randomized trials in (at least) 6 non-ICU departments. Study population: Elderly admitted to non-ICU departments with high risk of delirium. Intervention: During 12 months, frail elderly admitted to a non-ICU department of participating hospitals with high risk of delirium will be included in the study. First, all hospitals will apply 'usual care' to all patients, i.e. standard delirium screening (e.g. Delirium Observation Screening (DOS) or other currently used tools) in combination with a delirium treatment protocol and subsequent management without application of the DeltaScan for a period of 3 months. Then, during a 6 month period, each 5 weeks, starting at day 0, randomly allocated hospitals will sequentially start to apply the DeltaScan in all eligible patients (intervention period). During the last 3 months of the study all hospitals will participate in the intervention period. Main study endpoints: Primary endpoints: delirium detection rate (i.e. proportion of positive assessments according to the delirium detection tool), and duration of admission at the non-ICU department. Secondary endpoints: time interval between admission and the first delirium positive assessment, number of days with at least one positive delirium assessment, delirium incidence, hospital mortality, and direct medical costs of hospitalization. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: During the intervention period EEG recordings using the CE-certified DeltaScan will be made using a strip with EEG electrodes that will be mounted to the head using self-adhesive gel. The EEG recording will be performed two to three times daily and takes 3-4 minutes. During the usual care period the patients will receive the standard delirium screening tool for delirium assessment by a nurse. This assessment will be performed two to three times daily and takes 2-4 minutes depending on the screening tools that is used. Since the DeltaScan has shown to have superior diagnostic performance compared to the DSM5 the burden/risk of misclassification is lower than with the current standard for delirium assessment. Based on the above we consider the burden to participants in this study to be minimal.

NCT ID: NCT03682874 Terminated - Delirium Clinical Trials

Identifying Novel Aging Targets for Treatment of Delirium

INNOVATE
Start date: October 10, 2018
Phase:
Study type: Observational

The long-term goal of this research program is to improve understanding of the mechanistic link between Alzheimer's disease (AD) neuropathology, acute delirium, and cognitive impairment following acute respiratory failure. In this pilot study, the study team will establish a prospective cohort of older patients with acute respiratory failure and obtain data on delirium duration, AD imaging and CSF biomarkers, and cognitive outcomes following critical illness.

NCT ID: NCT03628391 Terminated - Critical Illness Clinical Trials

Haloperidol for Delirium in Adult Critically Ill Patients

EuRIDICE
Start date: February 22, 2018
Phase: Phase 3
Study type: Interventional

The EuRIDICE trial will study whether haloperidol as a first line treatment for ICU delirium reduces delirium duration (and severity). Adverse outcomes typically associated with delirium will also be studied and include long term cognition, functional outcome and quality of life. Further, patient and family experiences and cost-effectiveness will be assessed. Finally, safety concerns associated with the use of haloperidol in this vulnerable population will be studied.

NCT ID: NCT03628014 Terminated - Delirium Clinical Trials

The Hospital Elder Life Program at the Jewish General Hospital

HELP
Start date: February 5, 2018
Phase: N/A
Study type: Interventional

Older patients (i.e.; ≥ 65 years) with a hip fracture, and who are admitted to orthopedics for surgery are particularly at risk of adverse health events such as delirium, recurrent falls and prolonged hospital stay caused by their frailty status. The Hospital Elder Life Program (HELP) is a comprehensive inpatient-care program that ensures optimal care for older adults in the hospital and, thus, might reduce the incidence of postoperative adverse health events. The overall objective of this study is to examine in a quantitative fashion the effects of the HELP program on adverse health events in geriatric inpatients admitted to the orthopedic ward at JGH for surgery after a hip fracture.