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Delirium clinical trials

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NCT ID: NCT04078503 Recruiting - Critical Illness Clinical Trials

Neuroinflammation During ICU-associated Delirium in Critically Ill Patients and Its Association With Structural and Functional Brain Alterations: a Nested Case-control Study

Delirium-fMRI
Start date: March 25, 2019
Phase:
Study type: Observational [Patient Registry]

With the present study, the authors aim to improve the knowledge of the pathophysiology of ICU-related delirium. In particular, the authors would like to clarify the possible correlation between neuroinflammation, evaluated longitudinally by serum dosage of 20 different neuroinflammation biomarkers, and brain structural and functional alterations (using brain fMRI).

NCT ID: NCT04068311 Completed - Quality of Life Clinical Trials

Implementation of Multidisciplinary Assessments for Geriatric Patients in an ED Observation Unit

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

This project will implement a 2 step protocol for multidisciplinary geriatric assessment in the Emergency Department (ED). Candidate: Dr. Lauren Southerland is a Geriatric- and Emergency Medicine-trained physician at The Ohio State University Wexner Medical Center. Training: The career development plan will build upon Dr. Southerland's unique fellowship training in Geriatrics with courses in Implementation and Dissemination Science, a Black Belt in Lean Six Sigma, and Master's in Public Health courses. This combination will position her as an expert in Implementation research, with the career goal of translating validated, effective elements of geriatric care into the daily practice of Emergency Medicine. Mentors: Dr. Southerland has an experienced mentorship team who will provide guidance in the intricacies of emergency research (Dr. Jeffrey Caterino, MD, MPH), implementation strategies and studies of hospital staff and nurses (Dr. Lorraine Mion, PhD), implementation frameworks and reporting (Dr. Christopher Carpenter, an EM physician at Washington University at St. Louis), and identifying environmental and human factor barriers to quality care. Project: Multidisciplinary assessment by geriatricians, physical therapists, case managers, and pharmacists identifies and addresses underlying geriatric issues in older ED patients. However, only a few EDs across the country have been able to incorporate multidisciplinary care for their older patients, due to barriers such as personnel costs, work flow culture, and the 24 hour ED care model. We developed a two-step protocol to address these barriers: Step 1 is quick, sensitive screens for fall risk (4 Stage Balance Test), delirium (Brief Delirium Triage Screen), and frailty (Identifying Seniors at Risk Score). Patients with concerning results will be placed in an ED Observation Unit for (step 2) multidisciplinary geriatric assessment. In Aim 1 we will use the Consolidated Framework for Implementation Research and Lean Six Sigma methods to identify and address residual barriers to full implementation. Aim 2 will evaluate the effectiveness of this protocol in regards to patient-oriented outcomes (functional status and health-related quality of life at 90 days). By using implementation frameworks and processes, we will develop a protocol that is effective, sustainable, and ready for dissemination to EDs across the US.

NCT ID: NCT04065256 Completed - Critical Illness Clinical Trials

Effects of Music Therapy on Reducing Delirium in Mechanically Ventilated Adults in Intensive Care Unit

Start date: June 5, 2020
Phase: N/A
Study type: Interventional

Background: Delirium is a common acute confusion state in patients in intensive care units (ICUs). It has been linked to poor clinical prognoses (e.g., prolonged ICU stay) in critical patients. Furthermore, it might connect with long-term cognitive dysfunction. Mostly, pharmacological treatments have been frequently prescribed for preventing ICU delirium; however, their side effects might subsequently increase the risks of ICU delirium. Therefore, developing an effective non-pharmacological intervention of preventing delirium among critically mechanical ventilated patients is of clinical relevance. Purposes: To examine the effects of music intervention on reducing delirium in mechanically ventilated critical patients, to determine its beneficial effects on delirium-related outcomes, including sedation time, the duration of mechanical ventilation, and the length of ICU stay, and to compare the change of heart rate variability between groups.

NCT ID: NCT04062396 Completed - Cardiac Surgery Clinical Trials

Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction

CRIDD
Start date: September 26, 2019
Phase: N/A
Study type: Interventional

Age is no longer an absolute contraindication to cardiac surgery therefore there is often need for combined interventions (double valve repair/replacement, or coronary artery bypass graft and valve repair/replacement) with relative prolongation of cardiopulmonary bypass time. Prolonged cardiopulmonary bypass use causes an increase in the inflammatory response, and on the other a need for blood reinfusion and therefore lipid microemboli from the operative field. The clinical consequences for patients are post-operative delirium and post-operative cognitive impairment. These two neurological complications involve up to 45% of elderly patients undergoing cardiac surgery and have a significant impact on quality of life, hospitalization and mortality in the short and long term. The Remowell 2 oxygenator system has demonstrated in preliminary studies that, compared to the gold standard Inspire oxygenator, it can guarantee a significant reduction of hemodilution, inflammatory systemic response and embolization of lipid microemboli and leukocytes. In light of these considerations, it is possible to formulate the hypothesis that the use of the Remowell 2 device can contribute to significantly reducing the onset of post-operative delirium and cognitive impairment. The present study is designed to validate this hypothesis in a randomized controlled scenario.

NCT ID: NCT04058899 Active, not recruiting - Emergence Delirium Clinical Trials

Dexmedetomidine Versus Nalbuphine in Prevention of Emergence Agitation Following Adenotonsillectomy in Pediatrics

Start date: March 5, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of the present study is to compare the effect of IV infusion 0.5 µg/kg dexmedetomidine and IV 0.1 mg/kg nalbuphine in preschool children for prevention of emergence agitation after adenotonsillectomy under sevoflurane anesthesia.

NCT ID: NCT04056871 Completed - Clinical trials for Postoperative Delirium

Different Frailty Scores to Incidence of Post-operative Delirium and Cognitive Dysfunction

Start date: August 20, 2019
Phase:
Study type: Observational

Patients who are frail will have higher rate for post-operative morbidities, mortality, prolonged hospital stays, loss of independence, increase in institutionalization, post-operative cognitive dysfunction (POCD) and delirium (POD). So, it is crucial to find a suitable frailty assessment tool that can be incorporated into a guideline and reference for our local setting in geriatric peri-operative management. In the mean time, create awareness regarding the frailty elderly population with POD, POCD and other associated poor outcomes among our clinicians.

NCT ID: NCT04056338 Completed - Clinical trials for Intensive Care Unit Delirium

Gut Microbiome and ICU Delirium Post Cardiac Surgeries

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

ICU delirium are assessed by clinical nurses twice every day. Delirious patients are matched with patients according to their disease, gender and age range(±3 years). Stool samples for gene sequencing are collected. Gut barrier function are studied with several serum biomarkers (endotoxin, etc.). Ecological analyses, regression models and mediation equation will be performed.

NCT ID: NCT04047485 Enrolling by invitation - Dementia Clinical Trials

Evaluation of the Effect of Cataract Surgery on Cognitive Function in Very Elderly Patients

Start date: February 2, 2019
Phase:
Study type: Observational

The study intends to measure the evolution over time of the cognitive capacity of patients undergoing cataract surgery in relation to the opaque lens removal surgery (cataract) in a population considered to be at risk of neurocognitive degeneration. Secondary objectives: • Estimate the incidence of postoperative cognitive dysfunctions and any episodes of perioperative delirium with the aim of demonstrating the safety of cataract surgery in the elderly patient in terms of cognitive functions and impact on the psychological state. In the context of the study a risk sub-population analysis will be carried out, evaluating the trend over time of the "endothelial cells count" parameter The elderly population remains, due to the aging of the cornea, a population "at risk" for significant alterations from the clinical point of view. During the study the endothelial cells count will be monitored, in order to be able to evaluate the safety of the cataract surgery and to be able to correctly correlate a possible deterioration in the visual acuity of patients with corneal decompensation. To evaluate the progress of the endothelial cells count in the elderly patient during the pre-intervention and post-intervention period. Since the low values of cellular media in endothelial microscopy are an element that increases the risk of complications during cataract surgery, the study wants to assess how waiting times between filter visits and cataract surgery can cause an elderly patient worsening of this parameter even in a few months. The trend of the same parameter will be monitored even after the intervention since in case of decrease, the low endothelial count could cause an alteration of visual acuity and therefore a minor improvement in cognitive performance. The research will be set as a longitudinal observational study where will be compared in each patient the parameters analyzed in the 6 months prior to cataract surgery and in the 3 months following the operation itself. Patients will be enrolled during the first cataract filter visit, will be submitted to simple questions and their clinical data will be collected. Subsequently, before and after three months of surgery repeated cognitive testing and the control normally performed instrumental tests during follow-up. A clinical follow-up will be provided, during normal follow-up visits at 20 days and 6 months after the patient's surgery: the following information will be collected during these visits - BCVA (visual acuity) - endothelial cells microscopy - OCT macula and optic nerve - Catquest 9SF; - Barthel Index; - Six Item Cognitive Test - Confusion Assessment Method (CAM): this exam will be performed within 24 hours of post-surgery and 20 days after surgery. It is important to underline that the cognitive tests proposed to patients consist of simple questions that do not depend on the visual ability of the subject.

NCT ID: NCT04046458 Completed - Delirium Clinical Trials

De-escalating Vital Sign Checks

Start date: March 11, 2019
Phase: N/A
Study type: Interventional

The overall goals for this study are: 1) to develop a predictive model to identify patients who are stable enough to forego vital sign checks overnight, 2) incorporate this predictive model into the hospital electronic health record so physicians can view its output and use it to guide their decision-making around ordering reduced vital sign checks for select patients.

NCT ID: NCT04043663 Recruiting - Emergence Delirium Clinical Trials

Effects of Virtual Reality on Perioperative Pediatric Anxiety

VIRTUALPED
Start date: July 15, 2019
Phase: N/A
Study type: Interventional

This study evaluates the effect of virtual reality on anxiety levels in a pediatric surgical population. Half of participants will receive standard perioperative treatment, while the other half will receive additionally a virtual reality local program.