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Delirium clinical trials

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NCT ID: NCT05811208 Recruiting - Pain, Postoperative Clinical Trials

Use of Pupillometry for Pain Assessment in ICU Patients With Delirium

Start date: May 1, 2023
Phase:
Study type: Observational

Pain assessment in intensive care patients is a constant challenge. Approximately 50% to 80% of patients report pain at rest or during medical or nursing interventions (for example endotracheal suctioning, mobilization and rehabilitation, presence and care of invasive inputs, etc.). Obstacles to pain assessment and management are most often due to interference with communication due to impaired consciousness, airway support and connection to artificial pulmonary ventilation, or the effect of administered medication. Patients in intensive care are prone to delirium. Delirium can compromise patients' ability to verbalise pain for a variety of reasons (e.g. due to impaired attention, memory, thinking and language barriers). Also, pain and inadequate analgesia are risk factors for delirium. Pupillary reflex changes and their identification by automated pupillometry have yielded positive results regarding nociception assessment in adult and pediatric patients and in perioperative and postoperative care. At the same time, the response of these patients to opioid administration was investigated. The aim was to improve their analgesia. The aim of this study is to find out whether, there is an association between automated pupillometry and selected objective pain measurement scales in The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) positive patients after surgery.

NCT ID: NCT05806827 Not yet recruiting - Clinical trials for POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE

INVESTIGATE THE ASSOCIATION BETWEEN VIRAL NEUROTOXIC INFECTION AND POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE

CONNECTED
Start date: March 1, 2024
Phase:
Study type: Observational

In the last two decades, viral infections have increased dramatically : the 2003 severe acute respiratory syndrome coronavirus outbreak, the 2009 swine flu pandemic, the 2012 Middle East respiratory syndrome coronavirus outbreak, the 2013-2016 Ebola virus disease epidemic in West Africa and the 2015 Zika virus disease epidemic and not least the COVID-19 pandemic. At the same time, neurological disorders are a major and increasing global health challenge, which accounts for a substantial portion of the disease burden worldwide . In Europe, more than half of the population (approx. 60% ) suffers from a neurological disease, ranking number three among all disease groups . The figures are higher in the population with more than 65 years. Based on Eurostat annual publication "Aging Europe", in 2020 people over 65 represented 20.6% of the European Union population, and the projections show that the share of people over 65 is expected to strongly increase until 2058, reaching 30.3% of the EU population. Furthermore, while in civil aviation, the mortality rate is estimated around 0,00525% (Eurocontrol, 2022), the perioperative mortality rate in Europe is about 4% (Pearse et al., 2012). Clearly, the patients undergoing surgery already have a higher mortality risk depending on their initial medical conditions. However, the medical field can without doubts benefit from an improved risks assessment approach derived from the civil aviation. Against this backdrop, the project aims at: i) researching the correlation between a neurotoxic viruses' infection and the increased risk, in terms of frequency or severity, of developing a cognitive disfunction such as the postoperative cognitive dysfunction (POCD), by conducting an observational clinical trial on selected neurotoxic viruses (SARS-CoV-2, Herpes simplex virus, Cytomegalovirus and Epstein Barr virus). ii) developing a theoretical model for monitoring the implications of general anaesthesia in elder patients aged ≥ 65 years iii) designing a risk assessment mechanism, based on the best practices developed in the aerospace sector, for patients with neurotoxic infection and POCD, that can be furtherly scalable in other medical contexts. iv) building an AI-based platform, following the example of the NSQIP risk calculator for cardiovascular postoperative complications, both for data collection and data processing, able to return an estimate of the risk of perioperative-related cognitive complications in elder patients undergoing major elective surgeries. Observational Clinical Trial The clinical trial will recruit a sample of 1685 patients in eight centres (about 250 patients per centre, considering also the drop-out rate) to be finalised in 24 months. The primary end point of the clinical trial is to evaluate if patients undergoing general anaesthesia for elective major surgeries lasting longer than 1 hour that have an history of COVID-19 (not an active SARS-CoV-2 infection) do have a higher risk to develop postoperative cognitive dysfunction (POCD)/delayed neurocognitive recovery (DNC) at 3 months and 6 months follow up after surgery. Secondary end point include: 1. - Relationship between POCD/DNC with preoperative exposure to other neurotropic viruses: Herpes simplex virus (HS), Cytomegalovirus (CMV), and Epstein Barr virus (EBV). 2. - Development -on the basis of collected data- of a software dedicated to calculating in the preoperative phase the risk for early postoperative delirium or POCD/PNDs. 3. - Development of a conceptual model of "perioperative safety management": as in civil aviation traffic control, increasing the patients' perception of healthcare safety and quality. 4. - Delivery of training to healthcare practitioners concerning the preoperative evaluation of POD risk and the identification of patients at risk.

NCT ID: NCT05802082 Completed - Clinical trials for Postoperative Delirium

Preoperative Anxiety and Preemptive Analgesia on Postoperative Delirium in Adenotonsillectomy Surgery

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

The effects of preoperative anxiety and preemptive analgesia on PAED in children undergoing adenotonsillectomy surgery.

NCT ID: NCT05801289 Recruiting - Delirium Clinical Trials

Quetiapine as Prophylaxis for Delirium in CABG

Start date: December 4, 2022
Phase: N/A
Study type: Interventional

low-dose quetiapine may be effective in preventing delirium in patients. The purpose of this study is to evaluate the efficacy and safety of quetiapine for delirium prophylaxis in cabg

NCT ID: NCT05800639 Recruiting - Emergence Delirium Clinical Trials

Frontal Alpha Asymmetry and Pediatric Emergence Delirium

Start date: April 6, 2023
Phase:
Study type: Observational

This study aimed to investigate whether the association between the preoperative anxiety level and emergence delirium involves EEG frontal alpha asymmetry in pediatric patients undergoing ophthalmic surgery under general anesthesia. The investigators hypothesized that EEG frontal alpha asymmetry contributes a significant portion of the preoperative anxiety - emergence delirium association in pediatric patients. Mediation analysis will be performed to estimate the relationships between preoperative anxiety of children (modified Yale Preoperative Anxiety Scale (mYPAS)), EEG frontal alpha asymmetry, and emergence delirium (Pediatric Assessment of Emergence Delirium (PAED) scale).

NCT ID: NCT05798767 Completed - Clinical trials for Cognitive Impairment

Preoperative Cognitive Impairment Predicts Postoperative Delirium

Start date: February 1, 2022
Phase:
Study type: Observational

Preoperative cognitive impairment (PCI) may increase the incidence of postoperative delirium (POD), yet screening for cognitive impairment is rarely performed. This study hypothesized that Mini-Cog for preoperative cognitive impairment screening predicts postoperative delirium. Elderly patients (65 years or older) attending Henan Provincial People's Hospital during the trial period who required elective thoracic surgery were recruited into the study.

NCT ID: NCT05797194 Completed - Surgery Clinical Trials

The Association Between SIRI and POD in Older Patients

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

Postoperative delirium (POD) remains one of most common complication in elderly patients receiving surgery, which is characterized by acute and fluctuating change in the level of cognition and consciousness. Previous studies have shown that surgery and anesthesia-induced acute peripheral inflammation and neuroinflammation may lead to delirium after surgery. Systemic Inflammation Response Index (SIRI) is a more easily accessible and comprehensive inflammation marker derived from monocyte, neutrophil, and lymphocyte count, which has been investigated to assess the prognosis of cancer and infectious diseases. However, the relationship between SIRI and POD has yet to be investigated.

NCT ID: NCT05793632 Completed - Delirium Clinical Trials

Quetiapine in Prevention of Delirium

Start date: March 1, 2023
Phase: Phase 2
Study type: Interventional

The aim is to study the effectiveness of Quetiapine in preventing delirium in the elderly patients with multiple risks for delirium.

NCT ID: NCT05786833 Recruiting - Delirium Clinical Trials

Dexmedetomidine vs Ketofol on Delirium in Children Undergoing Congenital Inguinal Hernia Repair

Start date: March 20, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to compare the effect of dexmedetomidine versus ketofol on the incidence of the emergence delirium in children undergoing congenital inguinal hernia repair.

NCT ID: NCT05777187 Recruiting - Clinical trials for Cognitive Impairment

Mitigation of Postoperative Delirium in High-Risk Patients

Start date: June 20, 2023
Phase: N/A
Study type: Interventional

Among patients with cognitive impairment (CI) that undergo surgery, the risk for developing postoperative delirium (POD) is high (50%) and associated with further morbidity and mortality. Yet, 30-40% of POD cases are preventable with perioperative management. This randomized pragmatic clinical trial aims to assess incidence of POD in adult surgical patients with CI, as well as provider adherence to a set of 12 perioperative best practice recommendations for perioperative management. Electronic health record (EHR) data will be used to identify patients as high risk for developing POD and clinical decision support (CDS) prompts within the EHR will display best practices. Cases will be randomized to either the control group, usual care or the intervention which includes the high-risk alert and best practice prompts.