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Unconsciousness clinical trials

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NCT ID: NCT05496985 Completed - Brain Diseases Clinical Trials

Chinese Validation of the Simplified Evaluation of CONsciousness Disorders(SECONDs)

Start date: December 20, 2021
Phase: N/A
Study type: Interventional

The aim of this study was to translate the SECONDs from French into Chinese and assess the validity and reliability of the Chinese version of the SECONDs .

NCT ID: NCT05434494 Not yet recruiting - Remimazolam Clinical Trials

The Effect of Remifentanil on ED95 of Remimazolam for Loss of Consciousness in Adult Patients

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

This study prospectively uses the biased coin technique to investigate the effect of concomitant administration of remifentanil on the 95% effective dose of intravenous remimazolam (Effective dose 95 [ED95]) required for loss of consciousness during anesthesia induction. .

NCT ID: NCT05367999 Completed - Clinical trials for Consciousness Disorder

A Clinical Decision Aid for Diagnosing Transient Loss of Consciousness

Start date: February 9, 2022
Phase:
Study type: Observational

BACKGROUND: Transient loss of consciousness (TLOC) - defined as spontaneous disruption of consciousness not due to head trauma and with complete recovery - has a lifetime prevalence of 50%. It is one of the commonest neurological complaints in primary and emergency care. Over 90% of TLOC is due to either syncope, epilepsy or dissociative seizures (DS, also known as 'Psychogenic Nonepileptic Seizures'). The rapid and accurate distinction of these diagnoses is vital to allow appropriate further management but at least 20-30% of patients are not managed optimally or misdiagnosed. We have previously demonstrated that, in patients with established diagnoses of epilepsy, syncope, or DS, an automated classifier using only information from 36 questions based on patient experience and lay witness reports (the initial Paroxysmal Event Profile, iPEP) could accurately diagnose 86.0% of patients (with 100% sensitivity and 91.7% specificity for syncope) AIMS: To calibrate the iPEP for discrimination between syncope, epilepsy, and DS in patients newly presenting with TLOC, validate its performance in an independent sample, and to explore acceptability of the use of such a tool to people with TLOC and witnesses. METHODS: Nested qualitative-quantitative prospective single-centre development and validation of the iPEP in patients presenting to Emergency Departments, syncope or epilepsy clinics with first presentations of TLOC, with semi-structured interviews conducted with a purposive sample of participants from the quantitative study. The iPEP will be calibrated using a previously-described procedure for variable selection and training of Random Forest (RF) classifiers, and validated with assessment of overall classification accuracy, alongside sensitivity, specificity, positive and negative predictive values, and area under receiver-operating curve for each of the three target diagnoses. Performance will be evaluated against a benchmark set by results from previous research in patients with established diagnoses of epilepsy, syncope, and DS. OUTPUTS: Results will be submitted for publication in academic and professional literature. If performance from feasibility can be replicated in validation, the iPEP will be suitable to begin process of registration as a medical device for implementation in clinical pathways to minimise inappropriate referrals and treatment, streamline patient pathways, and enable earlier ordering of appropriate investigations to ensure prompt and appropriate diagnosis and management. If pilot performance could be replicated in this population and proportional savings from current estimated costs of misdiagnosis achieved, this could potentially save £63.9 million of annual UK healthcare expenditure.

NCT ID: NCT05124704 Completed - Gastric Cancer Clinical Trials

Propofol EC50 for Inducing Loss of Consciousness in General Combined Epidural Anesthesia

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

The beneficial of perioperative usage of thoracic epidural anesthesia and analgesia in various thoracic and upper abdominal surgery are well studied. However, intraoperative data are lacking whether combined thoracic epidural and general anesthesia have effect on the median (50%) effective effect-concentration (EC50) of propofol for inducing loss of consciousness (LOC). We performed this study among patients undergoing open gastrectomy in gastric cancer patients. Sixty patients undergoing open gastrectomy were randomly assigned to two groups with thoracic combined general anesthesia (TEA+GA) or general anesthesia (GA) alone. Target-controlled infusion (TCI) of propofol was used for anesthesia induction. The initial propofol concentration of target effect-site (Ceprop) was 3.5 ug/ml and was increased stepwise by 0.5ug/ml at each 4 min intervals by an un-down sequential method to reach LOC. The predicted Ceprop at the time of LOC, intravenous anesthetics, vasopressor requirement, emergency time from anesthesia and postoperative numeric rating scale (NRS) were recorded and analyzed between two groups.

NCT ID: NCT05112042 Completed - Anesthesia Clinical Trials

Detection and Classification of Levels of Consciousness Using Parietal EEG-fNIRS During Anesthesia

Start date: May 14, 2022
Phase:
Study type: Observational

The current evaluations of the levels of consciousness during anesthesia have limited precision. This can produce negative clinical consequences such as intraoperative awareness or neurological damage due to under- or over-infusion of anesthesia, respectively. The study's objective is to determine and classify biomarkers of electrical and hemodynamical brain activity associated with the levels of consciousness between wakefulness and anesthesia. For this purpose, a parietal electroencephalography (EEG) and a functional near-infrared spectroscopy (fNIRS) measurement paradigm will be used, as well as machine-learning. Volunteering patients (n = 25), who will be subject to an endoscopy procedure, will be measured during the infusion of anesthesia with propofol. EEG and fNIRS parameters will then be related to the Modified Ramsay clinical scale of consciousness.

NCT ID: NCT04903535 Enrolling by invitation - Healthy Clinical Trials

External Nitric Oxide Measurement Through SNO Degradation

Start date: May 10, 2021
Phase: N/A
Study type: Interventional

In this study, we aim to explore the feasibility of a novel, noninvasive SNO assay to acquire physiological SNO quantification from the human ear, forehead, or hands and test this new method of analysis. This study aims to help with the currently cumbersome and invasive procedures used to measure SNOs in the body. The proposed activities do not unnecessarily duplicate previous experiments.

NCT ID: NCT04901871 Completed - Clinical trials for Loss of Consciousness

Remimazolam Bolus for General Anesthesia

Start date: May 27, 2021
Phase: Phase 3
Study type: Interventional

It is important to estimate the adequate dose of remimazolam intravenous bolus injection to induce the loss of consciousness. We will determine the ED50 and ED95 of remimazolam intravenous bolus on the loss of consciousness in patients undergoing general anesthesia.

NCT ID: NCT04825366 Recruiting - Type 1 Diabetes Clinical Trials

Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training

FEEL-HIIT
Start date: August 3, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to investigate if the addition of a 12-week program of home-based high intensity interval training to a standard educational program aiming at preventing hypoglycemia episodes will restore hypoglycemia awareness in people living with type 1 diabetes and impaired awareness of hypoglycemia to a further extent than a standard educational program alone. Participants will be randomized for 12 weeks to the standard educational program with or without high intensity interval training. The Gold method will be used to identify people with impaired awareness of hypoglycemia. The educational program will consist of two education sessions on avoidance of hypoglycemia, causes of hypoglycemia, treatment (e.g. glucagon) of hypoglycemia, how to better recognize hypoglycemia symptoms, understand how to use a CGM/Flash-GM and understand CGM/Flash-GM reports to adjust insulin doses. Participants randomized to the training program will be asked to train three times per week for 12 weeks following the home-based program that will be provided to them. Participants will be asked to perform at least 2 training sessions per week (ideally all 3 sessions) with the exercise specialist on a virtual platform.

NCT ID: NCT04746820 Recruiting - Healthy Subjects Clinical Trials

Functional Near-infrared Spectroscopy in Unconscious Patients

fNIRS
Start date: January 15, 2020
Phase: N/A
Study type: Interventional

The study design is a single-center prospective pilot study. Hypothesis: Results of cerebral fNIRS examination in unconscious patients with severe hemorrhagic or ischemic stroke in the ICU are congruent with the results of SSEP and AEP. Hence, making it a potential prognostic tool for unconscious ICU patients. In a specific subgroup of unconscious patients after cardiac arrest and cardiopulmonary resuscitation the fNIRS measurement is congruent with the results of electroencephalography (EEG). The primary purpose of this study is to evaluate the agreement of the results of fNIRS examination to those of evoked potentials and EEG in unconscious ICU patients with severe hemorrhagic, or ischemic strokes or hypoxic brain injury after cardiac arrest and cardiopulmonary resuscitation. fNIRS will be compared to evoked potentials in an experimental group consisting of unconscious neuro-intensive care patients and in a control group consisting of healthy, conscious subjects. To compare fNIRS with evoked potentials there are two test phases: 1. The cerebral response to a somatosensory stimulus (peripheral nerve stimulation) is measured by fNIRS and SSEP 2. The cerebral response to an auditory stimulus is measured by fNIRS and AEP To avoid biases the following has to be considered: - The timing of the measurements plays an important role. A time difference between compared measurements can influence the outcome significantly due to deterioration or recovery of the neuronal network during the time gap. Therefore, fNIRS and evoked potentials will be measured simultaneously. - If the compared measurement methods are conducted by the same researcher the possibility of bias is high. Hence, two different researcher will conduct each one measurement without knowing the results of each other during the measurement.

NCT ID: NCT04694326 Completed - Diabetes Clinical Trials

The Incidence of Diabetes Unawareness in Patients Hospitalized Outside Internal Medicine Services and Related Factors

Start date: April 20, 2017
Phase:
Study type: Observational [Patient Registry]

Our purpose is to determine the prevalence of undiagnosed diabetes by checking HbA1c in patients hospitalized outside internal medicine services and assess whether or not there is a difference between those without diabetes awareness and those with known diabetes in terms of age, sex, education status, presence of comorbidity and Body Mass Index (BMI).