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Delirium Confusional State clinical trials

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NCT ID: NCT06176625 Active, not recruiting - Delirium Clinical Trials

Sight and Hearing Investigation Into Effects on Delirium

SHIELD
Start date: January 11, 2023
Phase: N/A
Study type: Interventional

The goal of this observational study is to learn about sensory loss in hospital patients with delirium. The main questions it aims to answer are: - Are hearing and vision loss related to increased risk of having delirium? - Do hearing and vision loss contribute to more severe delirium? - Do sensory loss and/or delirium affect patient satisfaction with hospital care? Participants will be asked to: - answer delirium screening questions, - undergo hearing & vision screenings, and - complete questionnaires about the hospital stay. The second part of this study is a clinical trial. Researchers will compare different hospital units to see if changing communication affects the number of patients with delirium. The main questions it aims to answer are: • Does sharing information about communication and/or providing hearing devices change the number of hospital patients with delirium? Participants in the study will be asked to complete delirium screenings and answer questions about their hearing and communication.

NCT ID: NCT05398211 Completed - Delirium in Old Age Clinical Trials

Music Therapy as a Treatment for Delirium in Acutely Hospitalized Older Patients

Start date: June 15, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to assess feasibility and potential effectiveness of two different music interventions for managing delirium symptoms in acute geriatric patients.

NCT ID: NCT05307003 Recruiting - Delirium Clinical Trials

Trazodone vs. Quetiapine for the Treatment of ICU Delirium

TQDelirium
Start date: April 1, 2023
Phase:
Study type: Observational

This is a single-center, prospective observational pilot study. The objective of this study is to evaluate the effectiveness of trazodone as compared to quetiapine, in the management of ICU delirium in adult (>=18 years old) surgical and medical ICU patients. The investigators will compare outcomes such as delirium duration, delirium-free days, coma-free days, in-hospital mortality, 28-day mortality, hospital length of stay (LOS), ICU LOS, mechanical ventilator days, complications, adverse effects, rescue medication use, delirium symptom severity, sleep duration, and sleep quality among participants receiving trazodone or quetiapine. The investigators hypothesize participants receiving trazodone will be associated with a shorter duration of delirium, decreased delirium severity, and improved sleep quality compared to participants receiving quetiapine.

NCT ID: NCT04957238 Recruiting - Critically Ill Clinical Trials

Physical Restraints in Intensive Care Unit Patients

ARBORéa
Start date: May 18, 2022
Phase: N/A
Study type: Interventional

The use of physical restraints is common practice in Intensive Care Units (ICU). This medically prescribed procedure requires full attention of medical and paramedical teams for its implementation, monitoring and ending, as a major restriction of patients' individual freedom. French highest authority for health has defined, for geriatrics and psychiatric units, ten criteria of good practice for physical restraints' use. Routine practice reports critically ill patients' safety as main reason of use. This decision, often left to the sole discretion of nurses, varies according to their own representation of this risk, and depends on several factors: seniority in ICU, nurse to patient ratio and personal workload. In order to reduce practices subjectivity and heterogeneity, we have developed a decision-making tool for physical restraints implementation. This tool is based on objective scales used on a daily basis concerning neurological status (Richmond Agitation-Sedation Scale (RASS) and Confusion Assessment Method for the ICU (CAM-ICU)). Disorientation or delirium can lead to severe incidents by promoting accidental removing of important devices such as arterial of venous line, drains among others. However, physical restraints are recognized as a major cause of delirium and agitation. Critically ill patients require rigorous evaluation of organ dysfunctions necessitating adequate invasive equipments, with associated risks of unexpected removal or alteration. Such events could urge caregivers to use physical restraints. Based on recent literature, about a third of ICU patients are restrained, and accidental deconditioning is mainly observed within these particular patients. In addition, three categories of patients have been defined according to the invasive nature of their equipment and therefore according to the risk associated with an unexpected withdrawal. Finally, presence of patient's family and their adherence to its surveillance were also implemented into the tool. Main study objective is to jointly investigate effectiveness and tolerance of a decision-making tool guiding physical restraints use in ICU patients.

NCT ID: NCT04840316 Not yet recruiting - Clinical trials for Complication,Postoperative

INcidence of PostOperative Delirium Incidence in Surgical Patients: an Observational Cohort Study in New Zealand

INPOD-NZ
Start date: June 30, 2021
Phase:
Study type: Observational

As the population of older adults increases, so too with the number of older adult patients that present for anesthesia and surgery. The development of delirium following surgery has some significant potential effects on patient outcomes; however, POD is often under diagnosed. Some studies reported that more than 50% of patients with delirium were undiagnosed by clinical teams. POD is associated with cognitive decline, increased hospital length of stay, discharge to institutional care, mortality and higher healthcare costs. POD contributes significantly to healthcare inefficiency; a diagnosis of POD is estimated by the Australian Commission on Quality and Safety in Healthcare to cost an additional $27,791 AUD. The incidence of POD reported in clinical trials depends on the risk profile of the study population, the frequency and duration of delirium assessments as well as the surgical procedure. Reported incidence may also vary due to the presence of high-risk pathways involving multi-specialty management and intervention. POD may present as either hyperactive or hypoactive subtypes, the latter being more difficult to detect. There are few reports on the incidence of POD in New Zealand national level datasets, with single centre studies primarily looking at in-hospital delirium and demonstrating an incidence of 11.2 to 29% on mixed and/or medical wards. A review of elderly patients with neck-of-femur fractures found the incidences of POD to be as high as 39%. The current data suggests a significant level of morbidity due to POD in New Zealand hospitals, however there is lack of national level data in the surgical population; which is crucial for establishing demographic and regional need for effective intervention.

NCT ID: NCT04725253 Not yet recruiting - Clinical trials for Delirium Confusional State

Nicotinamide to Prevent Delirium

Start date: January 21, 2021
Phase: N/A
Study type: Interventional

Delirium is defined as an acute change in mental status characterized by fluctuating disturbances of consciousness, attention, cognition, and perception, usually secondary to acute injuries such as trauma or infections. Delirium is more frequent in older adults, and is associated with important poor clinical outcomes including increased mortality, functional deterioration, and higher expenditures for healthcare systems. Although it is not the only one responsible, the inflammatory response plays a key role in the development of delirium. From the first descriptions of the condition 2500 years ago, it is known that patients who present with inflammatory injuries such as trauma (pe. hip fracture) or infections (sepsis), frequently develop delirium. Microglia, are an inflammatory cell with phagocytic capacity, that inhabit the nervous system and have a critical role in the regulation of the inflammatory response in the brain. It is known that microglia have receptors that respond to systemic inflammatory mediators by generating new inflammatory mediators that exert their effect on other glial cells and neurons in the central nervous system, affecting their function. Mouse models have shown that depleting the brain of microglia prevents cognitive decline after a traumatic bone injury, suggesting a role of these cells in the development of delirium. Poly(ADP-ribose) polymerase-1 (PARP-1) is a nuclear enzyme that participates in DNA repair, and in the regulation of the expression of inflammatory mediators by immune cell. In vitro experiments have shown that PARP-1 enhances the microglial response to inflammation, and data from mice exposed to the bacterial component "lipo-poly-saccharide (LPS)", a classical model of delirium, showed that pharmacological inhibition of PARP-1 prevents cognitive decline secondary to that injury. Interestingly, nicotinamide, a vitamin widely available in the market, with a well-known safety profile in humans, is a well-recognized inhibitor of PARP-1. The role of PARP-1 nor nicotinamide in delirium has never been explored. Considering that, 1) there is evidence showing that PARP-1 may act as an enhancer of the inflammatory response of microglia and 2) the protective effect against cognitive impairment produced by pharmacological inhibition of PARP-1 in a mice model of delirium, we propose as hypothesis that PARP-1 participates in delirium pathogenesis by enhancing microglial activation in response to systemic inflammation. To address this hypothesis in patients, we propose to determine in a randomized clinical trial whether nicotinamide, a pharmacological inhibitor of PARP-1, is more effective than placebo for the prevention of delirium in older adults with requirement of oxygen (non-invasive) and suspected coronavirus disease (COVID-19) under study. The results of this research will contribute significantly in the field of delirium, improving the knowledge of its physiopathology, as well with the development of of new alternatives for its prevention in clinical practice.

NCT ID: NCT04084821 Not yet recruiting - Delirium Clinical Trials

Estimation of Delirium Data Completeness

Start date: October 2019
Phase:
Study type: Observational

Currently physicians and nurses rely on their own clinical skills and experience to diagnose and record 'delirium' in the Electronic Health Records (EHR). This study aims to determine how delirium as a diagnosis is documented by clinicians in the EHR at Hadassah Hospital. The knowledge gained from this study will support the design of a better surveillance approach to monitoring delirium events in postoperative patients using electronic healthcare recorded data. There is considerable uncertainty surrounding the quality of 'delirium' records in the Electronic Health Records (EHR). The reliability of this chart estimation has become questionable in the absence of an objective definition of 'delirium' and a lack of highly accurate diagnostic tools in the hospital setting. Given the difficulty of accurately identifying delirium and the deficiency in the quality of EHR documentation, it is not surprising that delirium is grossly underestimated, undertreated, not properly recorded in the EHR or misreported. Data concordance plays a major role in documentation quality, especially for data-mining and knowledge extraction analysis, and therefore it is essential to address the reliability of 'delirium' labeled data within the EHR system.

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.