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Confusion clinical trials

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NCT ID: NCT05897060 Recruiting - Clinical trials for Post-Operative Confusion

Braindex Cerebral Tissue Oxygen Saturation (SctO2) Measurement Algorithm Assessment and Improvement

POC-SctO2
Start date: May 11, 2023
Phase: N/A
Study type: Interventional

The objective of this clinical trial is to optimize Braindex brain tissue oxygen saturation (SctO2) measurement algorithm compared to a mixed reference value of jugular venous and systemic arterial saturation, during proven reproducible and standardized loss of brain autoregulation induced during transcatheter aortic valve replacement procedures. The main question it aims to answer is: assessing and improving the sensitivity/specificity of Braindex SctO2 measurements. Study type: single-center, prospective, interventional, open-label, exploratory clinical trial. Participant population/health status: - Patient, male or female, over 18 years of age - Patient scheduled for percutaneous femoral aortic valve replacement with aortic valve balloon deployment (Edwards Sapien valve) under simple sedation with Remifentanil (TIVA), with spontaneous ventilation. The expected outcome of this research is to optimize in vivo the algorithm for calculating the SctO2 of the BRAINDEX sensor in surgical conditions, in a context of proven low cerebral flow, on a target population. It is expected, in the long run, a better quality of detection of the loss of cerebral auto-regulation leading to a faster and optimal correction, thus potentially limiting the risk of POCD, subcortical stroke and postoperative cognitive decline.

NCT ID: NCT05510401 Recruiting - Clinical trials for Cognitive Impairment

Evaluation of Safe Use of SECURIDRAP® SELFIA®

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

Interventional, multicenter, prospective and non-comparative clinical investigation carried out in 9 French establishments in order to assess the safety of the SÉCURIDRAP® SELFIA® bedding by mesasuring all the adverse events likend to its use. Following the withdrawal from the market of the first version of the SECURIDRAP® SELFIA®, this clinical investigation is being carried out at the request and on the recommandation of the ASNM in order to assess the safety of the second version of the SECURIDRAP® SELFIA® coating.

NCT ID: NCT05378659 Recruiting - Alzheimer Disease Clinical Trials

Neuroinflammation and Alzheimer's Pathology in POCD

POCD
Start date: November 1, 2021
Phase:
Study type: Observational

The purpose of this project is to investigate the role of both neural inflammation and pre-existing neurodegenerative pathology in the risk and pathogenesis of post-operative cognitive dysfunction (POCD). To achieve this goal, the investigators will combine blood and cerebrospinal fluid (CSF) sampling, standardized cognitive tests, and dynamic neurophysiological markers of cortical network dysfunction in the form of event-related potentials (ERPs), to assess the link between neurodegeneration and neuroinflammation in the pathogenesis of POCD.

NCT ID: NCT05374356 Recruiting - Clinical trials for Post-Operative Confusion

High Spinal Anesthesia and the Incidence of Delirium After Cardiac Surgery

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

This is a feasibility study to determine if enough patients undergoing elective or urgent cardiac surgery, can be enrolled in a study where patients are randomized to receive high spinal anesthesia as an adjunct to general anesthesia for their cardiac surgery. The primary clinical outcome will be the incidence of post-operative delirium.

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: NCT05127265 Recruiting - Pain Clinical Trials

Pervasive Sensing and AI in Intelligent ICU

Start date: May 24, 2021
Phase:
Study type: Observational

Important information related to the visual assessment of patients, such as facial expressions, head and extremity movements, posture, and mobility are captured sporadically by overburdened nurses, or are not captured at all. Consequently, these important visual cues, although associated with critical indices such as physical functioning, pain, delirious state, and impending clinical deterioration, often cannot be incorporated into clinical status. The overall objectives of this project are to sense, quantify, and communicate patients' clinical conditions in an autonomous and precise manner, and develop a pervasive intelligent sensing system that combines deep learning algorithms with continuous data from inertial, color, and depth image sensors for autonomous visual assessment of critically ill patients. The central hypothesis is that deep learning models will be superior to existing acuity clinical scores by predicting acuity in a dynamic, precise, and interpretable manner, using autonomous assessment of pain, emotional distress, and physical function, together with clinical and physiologic data.

NCT ID: NCT05108207 Recruiting - Delirium Clinical Trials

A Software to Prevent Delirium (PREVEDEL) in Hospitalized Older Adults

PREVEDEL
Start date: August 1, 2021
Phase: N/A
Study type: Interventional

Background Delirium, is a clinical condition characterized by acute and fluctuating deterioration of the cognitive state, generally secondary to an acute pathology. It is a common condition in hospitalized older adults and it develops in 20-30% of patients hospitalized in a general ward and up to 80% of those hospitalized in critical care units. Delirium is associated with negative outcomes in older adults, such as longer hospitalizations, higher mortality, and short and medium-term institutionalization. Randomized clinical trials have shown that delirium is preventable through non-pharmacological prevention measures, decreasing its incidence by 30 to 50%. These interventions include promoting physical activity, facilitating the use of glasses and hearing aids, cognitive stimulation, and providing frequent reorientation of time and space, among others. These measures are currently seldom applied in hospitals in Chile and around the world for various reasons some of which include the heavy workload of clinical staff, the lack of trained personnel, and, in general, the absence of systematic implementation processes. The main objective is to evaluate whether cognitive stimulation guided by PREVEDEL software prevents delirium status(full/subsyncromal delirium) in hospitalized older adults. Method/Design: randomized controlled trial, parallel groups, multicenter. Participants: patients 65 years or older who have been hospitalized for less than 48 hours in the general ward or in the intermediate care unit of 4 hospitals in Santiago, Chile. Intervention: participants in the intervention group will use a tablet with cognitive stimulation software for delirium prevention for 5 continuous days versus the control group who will use the tablet without the software. Evaluations: The incidence of delirium and subsyndromal delirium, duration, density of delirium, cognitive and functional status at discharge, adherence to prevention measures, as well as demographic variables of interest will be evaluated.

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: NCT04907565 Recruiting - Obesity Clinical Trials

Impact of Obesity on Post-operative Cognitive Dysfunction: Role of Adipose Tissue

ODCOTA
Start date: September 21, 2021
Phase:
Study type: Observational

This research aims at describing the relationship between white adipose tissue inflammation and post-operative cognitive dysfunctions.The possible link between inflammatory cytokines secretions of the white adipose tissue of a surgical wound and the arising of patient's cognitive dysfunction in the post-operative course will be investigated. The hypothesis is that obese patient's inflammation of the white adipose tissue leads to cognitive dysfunction.

NCT ID: NCT04531371 Recruiting - Clinical trials for Postoperative Confusion

Magnesium Sulphate, Dexemeditomedine and Emergency Agitation

agitation
Start date: June 1, 2020
Phase: Phase 1
Study type: Interventional

Emergence agitation is a postanesthetic phenomenon that develops in the early phase of general anesthesia recovery, and is characterized by agitation, confusion, disorientation, and possible violent behavior. Though agitation is observed more frequently in pediatric patients, the incidence in adults has been reported at 4.7% or 21.3%. Emergence agitation can lead to serious consequences such as self-extubation, removal of catheters, hemorrhage, and even severe injuries from falling out of the bed. Furthermore, it may increase the demand on human resources and cause medical staff injuries.