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Delirium clinical trials

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NCT ID: NCT03724201 Completed - Delirium Clinical Trials

Neuronal Damage In Delirium Study

NDID
Start date: July 30, 2018
Phase:
Study type: Observational

The purpose of this study is to evaluate associations between neuronal damage biomarkers (S100 calcium-binding protein beta [S-100β], neuron-specific enolase [NSE], ubiquitin carboxy-terminal hydrolase L1 [UCHL1], and brain-derived neurotropic factor [BDNF]) and delirium severity and subsyndromal delirium in a homogeneous population of mechanically ventilated patients with sepsis.

NCT ID: NCT03715244 Completed - Delirium Clinical Trials

Rate of Postoperative Delirium and Postoperative Cognitive Dysfunction After Spinal Anesthesia

Start date: March 12, 2019
Phase:
Study type: Observational

The aim of this investigation is to compare the standard of general anesthesia used in these patients with these short-acting local anesthetics (Chloroprocain (Ampres®) and Prilocain (Takipril®)) for spinal anesthesia as well as to report the patient centered outcome of postoperative delirium and neurocognitive disorder. In accordance to current evidence regarding the occurrence of postoperative delirium and postoperative cognitive deficit, patients are to be screened daily for delirium up to the fifth postoperative day if in hospital, or till the first postoperative day after ambulatory surgery and for neurocognitive disorder 1 year following the surgery. To detect delirium the Nu-DESC (Nursing Delirium Screening Scale) will be used as a validated scoring systems to ensure the highest sensitivity in delirium identification. CANTAB battery will be used for assessment of neurocognitive disorder. This is a neuropsychological testing (computer-based (I-Pad) [Cambridge Neuropsychological Test Automated Battery - CANTAB connect and parameters from the item list], as well as the subjective / by proxy Assessment of Cognitive Limitations. It is essential to perform the appropriate cognitive performance tests not only on operative patients but also on a non-surgical cohort, using currently established models of calculation in postoperative cognitive deficits and a control group generated from non-surgical patients.

NCT ID: NCT03706989 Completed - Clinical trials for Postoperative Delirium

Predicting Postoperative Delirium Using EEG, Genetics and Neurobiomarkers of Cerebral Injury

POD-01
Start date: May 15, 2019
Phase: N/A
Study type: Interventional

The overall goal of this research project is to elucidate underlying pathophysiological mechanisms of postoperative delirium (POD) and to specifically validate perioperative predictive factors that will help in indentifying patients at higher risk of developing POD. 1. The main objective is to evaluate whether intraoperative frontal alpha power in unprocessed electroencephalogram (EEG), under general anesthesia, is associated with the occurrence of POD, and whether specific patterns worrelate with the patient's preoperative cognitive status. 2. As apolipoprotein E (APOE) polymorphism has been shown to be a risk factor of POD, we will specifically analyze whether patients who are APOEe4 carriers present different intraoperative EEG patterns in terms of anteriorization of the alpha frequency band under general anesthesia, and investigate whether the APOEe4 carriers are at higher risk of POD. 3. In this research project, we will also analyze the perioperative kinetics of serum neurofilament light chain protein (NfL), a biomarker of neuronal injury. We will specifically analyze whether preoperative, as well as postoperative serum NfL levels are higher in patients presenting POD, compared to those who do not experience POD. This will allow studying whether neuronal damage may be involved in the pathogenesis of POD.

NCT ID: NCT03704090 Completed - Clinical trials for Postoperative Delirium

Non-pharmacological Prevention of Postoperative Delirium by Occupational Therapy Teams

PREPODOT
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

In the world, 230 million surgeries are performed every year and US data indicates that more than a third of patients who undergo surgery are older than 65 years, in which between 10 and 70% develop postoperative delirium (POD). Patients who develop POD have poor outcomes, such as a longer hospital stay, a deterioration in functional and cognitive status, high mortality rates, and an increase in health costs. Delirium is an entity that in a significant percentage is preventable, thus preventing the development of POD is fundamental. In fact, in older adults hospitalized in the no surgical ward, the implementation of non-pharmacological prevention measures of delirium has consistently shown to significantly prevent the development of this condition. However, limited information is available about the usefulness of non-pharmacological intervention protocols applied in the perioperative context to prevent POD. The main aim of this project is to determine whether the application of non-pharmacological measures during the perioperative period prevents POD in elderly patients undergoing highly complex elective surgeries. The hypothesis is that the application of these measures decreases the incidence of delirium in this population.

NCT ID: NCT03684460 Completed - Clinical trials for Circadian Rhythm Disorders

Daytime Bright Light, Circadian Abnormalities, and Delirium in Medical ICU Patients

Start date: July 8, 2019
Phase: N/A
Study type: Interventional

To determine if daytime bright light will promote circadian alignment and shorten or prevent delirium.

NCT ID: NCT03642249 Completed - Delirium Clinical Trials

Education for Recognition and Management of Delirium

Start date: November 5, 2019
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: NCT03606941 Completed - Clinical trials for Postoperative Delirium

Effect of Electroacupuncture on the Incidence of Postoperative Delirium in Elderly Patients Undergoing the Major Surgery

Start date: September 7, 2018
Phase: N/A
Study type: Interventional

1. Title: Effect of electroacupuncture on the incidence of postoperative delirium in elderly patients undergoing the major surgery. 2. Research center: Multicenter 3. The Design of the study: Randomized, double-blind, controlled study 4. The population of the study: Elderly patients(65≤age<90 years),it is planned to select a period/time limit for gastrointestinal tumor surgery, bile duct surgery, thoracic surgery or orthopedic surgery and so on under general anesthesia, and the estimated operation time≥ 2 hours. 5. Sample size: Enroll 1100 patients (550 patients in each group) 6. Interventions: Participants in the treatment group received acupuncture (0.30mm×70mm) at bilaterally Shenmen (HT7) acupoints (0.3-0.5 inch), Neiguan (PC6) acupoints (0.5-1 inch), Baihui (DU20) acupoint (0.5-0.8 inch) and Yintang (EX-HN3) acupoint (0.3-0.5 inch) 30 minutes before anesthesia induction. After "Deqi", electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) is connected and maintained the end of operation. Participants in the control group received shallow needling (0.30mm×25mm) at bilateral sham HT7, PC6, DU20 and EX-HN3 (nonacupoints located 1 inch beside acupoints, about 20mm). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no "Deqi" without actual current output. 7. The aim of the research: To investigate the effect of electroacupuncture on the incidence of postoperative delirium within 5 days in elderly patients undergoing the major surgery. 8. Outcome: 1) Primary outcome:The incidence of delirium within 5 days after surgery;The effects on postoperative NRS pain and sleep quality scores; 2)Secondary outcome:Duration of mechanical ventilation in patients with endotracheal intubation on ICU admission; Length of stay in ICU and Length of stay in hospital after surgery; Incidence of postoperative complications (including re-hospitalization); 30-day life quality and cognitive function after surgery; All-cause 30-day mortality after surgery. 9. The estimated duration of the study:3-4 years.

NCT ID: NCT03604809 Completed - Delirium Clinical Trials

Guided Occupational Therapist Cognitive Interventions in Critically Ill Patients

GOTCI
Start date: June 15, 2019
Phase: N/A
Study type: Interventional

Title: Guided Occupational Therapist (OT) Cognitive Interventions for Critically Ill Patients Short Title: GOTCI Methodology: Randomized Control Trial Study Duration: 12-15 months Study Centre: Single Center - South Health Campus, ICU, Calgary, Alberta, Canada Objectives: The aim for this study is to evaluate the effect of specific OT guided cognitive interventions on delirium in adult critically ill patients. Number of Subjects: 112 Primary Outcome: Delirium Prevalence and Duration Secondary Outcomes: Cognitive function, physical function, quality of life, ICU length of stay, hospital length of stay and days of mechanical ventilation. Inclusion Criteria: Adult Critically Ill Patients admitted to South Health Campus ICU, Calgary, Alberta Type of Intervention: OT guided cognitive intervention based on RASS score Dose: One on one therapeutic sessions with an OT. Five days a week, Monday to Friday, between 0800-1600. There will be twice daily sessions for 20 minutes each. Duration of administration: Cognitive Therapy to be initiated Monday to Friday, for the duration of participant ICU admission. Reference therapy: Standard of care within the Department of Critical Care Medicine in Calgary is delirium prevention strategies using the ABCDEF bundled approach. Statistical Methodology: Descriptive statistics (mean, median, proportion) will be employed to describe the study population. The primary outcome of delirium prevalence will be explored using multivariable logistic regression, which will provide an estimate of the odds ratio and accompanying 95% confidence intervals. Both per protocol and intent to treat analyses will be performed.

NCT ID: NCT03588689 Completed - Pain Clinical Trials

Continuous Fascia Iliaca Block for Acute Hip Fractures

Start date: May 7, 2018
Phase: Phase 4
Study type: Interventional

Hip fractures are a major cause of morbidity and mortality in the elderly with over 30,000 hip fractures occuring in Canada annually and over 1300 in Saskatchewan. The estimated cost associated with hip fractures is over $600 million nationally and 28 million dollars in Saskatchewan. Hip fractures cause a great deal of pain and immobility and are mainly treated with surgical fixation. In the perioperative period, hip fracture patients are treated mainly with opioids and other adjuncts such as NSAIDS and acetaminophen. Opioid consumption in the elderly population can predispose to delirium and respiratory complications such as atelectasis, respiratory depression, and pneumonia. Fascia iliaca blocks have been shown to be an effective mode of analgesia for patients with hip fractures, but are underutilized for varying reasons including culture of practice, expertise with performing the block, and having a dedicated service to do so. This study aims to compare the efficacy of fascia iliaca blocks to standard treatment (opioids) in the management of pain in hip fracture patients with a particular focus on outcomes such as the incidence of delirium, respiratory complications, and length of stay in hospital. Our idea is that if we can reduce the amount of opioids these patients receive then they will have improved pain control, fewer respiratory complications, earlier time to mobilizing, and shorter hospital stays. As far as we are aware this relation has not been well studied.

NCT ID: NCT03573843 Completed - Delirium in Old Age Clinical Trials

Software-guided Cognitive Stimulation to Prevents Delirium

Prevedel
Start date: June 15, 2018
Phase: N/A
Study type: Interventional

This study is a pilot randomized controlled trial, comparing a group of older patients with standardized non-pharmacological delirium prevention plus a basic tablet versus a group with standardized non-pharmacological delirium prevention plus a tablet with a software of cognitive stimulation (PREVEDEL). Software:It is a local development, including a interprofessional team of delirium healthcare experts, older patients and a team og engineers. The software was developed during the first year of this project and was inscribed for author rights. Inclusion criteria: Older patients > 65 y.o. Admitted to medicine room or intermediate care unit > 48 hrs, and informed consent to participate. Exclusion Criteria:Delirium positive, neuroleptic use, dementia, and non-spanish speakers. The study was approved by ethical committee of Hospital Clinico University of Chile Standardized Non-pharmacological intervention: Health workers were previously educated in delirium, and environmental issues were implemented. This intervention coverage in nine different domains: orientation, early mobilization, environmental noise and light, sensorial deficit, sleep, hydratation, drug reduction, and family participation. Intervention: All patients will have a tablet with or without the software PREVEDEL between 09:00-19:00 hrs. Measures: delirium will be monitoring with CAM (Confusion Assessment Method) twice a day for 5 days. Primary outcome: Delirium rate between both groups Secondary outcomes:Long of stay, severity od delirium, time of use of electronic device, and Barthel to discharge.