View clinical trials related to Unconsciousness.
Filter by:This observational study aims to describe the incidence of episodes of disconnected consciousness (including near-death experience (NDE)) and episodes of connected consciousness in patients admitted to the resuscitation room, who survived a critical condition and who meet at least one of these criteria during their stay in the resuscitation room: (1) deep sedation, (2) intubation, (3) cardiopulmonary resuscitation, or (4) (non-drug-induced) Glasgow Coma Scale score = 3. We also investigate the potential (neuro)physiological markers and biomarkers. In order to help determine the potential risk factors of such episodes, cognitive factors such as dissociative propensity are also investigated. Unexpected visual and auditory stimuli will be displayed. In addition, we assess the evolution of memory, as well as short- and long-term consequences on quality of life, anxiety, and attitudes towards care. Memory of patients who did not meet the above-mentioned criteria are also investigated. A group of 15 healthy participants will be invited to test the stimuli display. Finally, (neuro)physiological parameters of a subsample of dying patients are also investigated.
This prospective observational high-fidelity simulation study aims to observe and better understand how physicians from different disciplines differentiate in the management of a comatose patient and how their diagnostic and treatment approaches adhere to current recommendations in a highly standardized simulated scenario. The results gained by this study will give more insight into the current quality of diagnostic procedures and treatment and help refine recommendations in this context. The investigators hypothesize that physicians do not strictly adhere (regarding diagnostic approach and treatment) to current guidelines/recommendations when confronted with a comatose patient.
ciprofol is a recently introduced novel sedative drug. In comparison to the traditional propofol, ciprofol exhibits a higher affinity for GABA A receptors, approximately 4-5 times that of propofol, and possesses fewer side effects, particularly notable in respiratory depression and injection pain. In the context of general anesthesia induction, recent research has confirmed a 100% success rate in the induction of general anesthesia for elderly patients (65-80 years old) undergoing non-cardiac surgery with a dosage range of 0.2mg/kg-0.4mg/kg ciprofol. However, for elderly patients aged 65 and above, even up to 85 years old, it is currently not entirely clear what dosage should be selected for patients in different age groups. Consequently, we have designed this trial with the aim of exploring the dosage requirements of ciprofol during general anesthesia induction among elderly patients in various age brackets. Methods: This is a prospective, non-controlled, non-randomized, single-blind study. Elderly patients aged 65 years and older were enrolled in the study with American Society of Anesthesiologists (ASA) physical status I or II undergoing general anesthesia. All patients were divided into five groups according to age, and the corresponding initial dose of ciprofol administered was selected according to the grouping, with subsequent doses of ciprofol determined according to the Dixon up-and-down method. At least seven crossover points were obtained before the conclusion of the study.The primary outcomes were the dose of ciprofol administered at the time of loss of consciousness (mg/Kg) and the plasma concentration of ciprofol.
Our understanding of neurosecretory dysfunction after TBI is still insufficient, and the number of patients with neuroendocrine dysfunction caused by craniocerebral trauma may be underestimated, especially the neuroendocrine changes related to HPA axis in the early stage after craniocerebral trauma. Moreover, there are few and fragmentary literature data on the benefits of hormone replacement therapy in patients with neuroendocrine disorders after traumatic brain injury. This requires more studies to further determine the characteristics of pituitary function or hormone disorders in the early stage after traumatic brain injury, which makes it necessary for us to further study the neuroendocrine dysfunction (hormone disorder) in the early stage after craniocerebral injury. To explore the relationship between craniocerebral injury and early hormone disorder by measuring the changes of early hormone levels in patients with TBI is of great significance for the early detection of related complications after craniocerebral injury and the evaluation of the prognosis of patients with craniocerebral injury, and can provide a new diagnosis and treatment plan for early intervention of related complications after TBI.
Traumatic Brain Injury (TBI) is an alteration of brain function caused by an external force. Long-term mortality in TBI is substantial, TBI survivors can develop chronic progressive disabilities and have a life expectancy shortened by 6 years. Treatment consists in supportive therapy directed at prevention of second insults, but no neuroprotective therapy is available. Given the multifaceted nature of TBI, mesenchymal stromal cells (MSCs) are an ideal candidate: they release multiple soluble factors shown to ameliorate the injury microenvironment through immunomodulatory, protective, reparative and regenerative processes. Preclinical data across a range of different TBI models and injury severities show that human MSCs improve outcome through pleiotropic mechanisms of protection and repair. Thus, data indicate MSCs as strong therapeutic candidate and support a clinical study in TBI. Aim: the study is designed to assess the safety and the efficacy of the MSCs, intravenously administered in severe TBI patients within 48h from injury. The study will be conducted in a stepwise manner. Step 1 will enroll 36 patients (randomized 1:1:1 in arms 80 x 10^6 MSCs vs 160 x 10^6 MSCs vs placebo) to define safety, and will allow to select the most promising dose. Step 2 will enroll 30 patients (1:1 in arms MSCs selected dose vs placebo) to define the MSC activity based on the quantification of the plasmatic levels of the neurofilament light (NFL) at 14 days, as biomarker of neuronal damage. Secondary objectives are aimed to assess: 1. brain injury evolution and white matter damage by longitudinal neuroimaging (at 4 days and 14 days post-TBI and at 6 months) 2. brain immunomodulatory changes by temporal profiling of circulating biomarkers of brain damage and neuroinflammation (daily for 3 days after TBI, at day 7 and 14, and at 1, 6 and 12 months) 3. clinical outcome by a structured clinical and neuropsychological assessment at both 6 and 12 months Methods: a multicenter, double blind, randomized, placebo-controlled, adaptive phase II dose finding study. Duration of the study: 36 months (24 of enrolment and 12 of follow up). Funding: Fondazione Regionale per la ricerca Biomedica, FRRB (Call "Unmet medical needs", proposal number 3440227) and Italian Ministry of health (Ministero della Salute, Bando di Ricerca Finalizzata 2021; proposal number RF-2021-12372642).
Early prediction of outcomes after acute brain injury (ABI) remains a major unsolved problem. Presently, physicians make predictions using clinical examination, traditional scoring systems, and statistical models. In this study, we will use a novel technique, "SeeMe," to objectively assess the level of consciousness in patients suffering from comas following ABI. SeeMe is a program that quantifies total facial motion over time and compares the response after a spoken command (i.e. "open your eyes") to a pre-stimulus baseline.
This behavioral study on healthy participants aims to provide a baseline reference for assessing alterations of decision-making performance in pathological conditions. To this purpose, this single center non-interventional behavioral study will assess the extent to which decision-making performance is affected by distinct experimental manipulations, as well as by ageing effects, in 200 healthy individuals. The main questions it aims to answer are: - to what extent is decision-making performance stable, within individuals, regardless of non-economic manipulations concerning stimuli perceptual features as well as type of processing and motor response required to participants? - are these manipulations additionally influenced by participants' age? Healthy participants will be recruited for distinct behavioral studies assessing the effects of the aforementioned manipulations of distinct metrics of decision-making performance, such as loss aversion, risk aversion, and delay discounting.
Determine the feasibility, practicality, and early efficacy of a TeleRehab program (ICARE) to improve outcomes for persons with traumatic brain injury (TBI) in recognizing and responding to others' emotions alongside their care partner (CP).
To examine the feasibility, acceptability, and preliminary efficacy of a remotely delivered intervention for civilians and service members with mild traumatic brain injury (mTBI) who have difficulty recognizing and regulating their emotions. Post-treatment outcomes of interest include emotional self-awareness and regulation, resiliency, and affective symptoms.
The goal of this observational study is to examine the clinical presentations, the diagnostic tests performed and the management of patients presenting with transient loss of consciousness (TLOC) The main questions it aims to answer are: - prevalence of TLOC - prevalence of different diagnoses leading to TLOC Demographic, clinical, paraclinical and biological data will be collected from the emergency medical file