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Unconsciousness clinical trials

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NCT ID: NCT06270264 Completed - Pressure Ulcer Clinical Trials

Nociception Monitoring in Intensive Care

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

Precisely, pain in the ICU is a multidimensional problem with a multivariate of reasons. Still, it would be simpler to manage it in unconscious palliative patients with less source of pain, but only if we can detect it practically with the help of nociception monitors. Using five parameters, nociception level index (NOL) monitoring (Medasense) is differentiated from its alternatives. Other than pain detection, this monitoring can titrate analgesic administration. This study investigates the validity of a new nociception monitoring tool, the nociception level index, and its practical impact on providing adequate analgesia in palliative patients in intensive care.

NCT ID: NCT05587179 Completed - Unconsciousness Clinical Trials

The Impact of Different Recovery Positions on the Perfusion of the Lower Forearm and Comfort

Start date: December 21, 2022
Phase: N/A
Study type: Interventional

Introduction: A side-lying recovery position is recommended when victims are unresponsive but breathing normally and, hence, do not require cardiopulmonary resuscitation. In 2021, the European Resuscitation Council (ERC) and the Belgian Red Cross-Flanders issued new guidelines which included the description of a modified recovery position to avoid problems in victims with joint stiffness and to overcome potential obstructed venous return in the dependent arm. Based on good practice insights, the dependent arm will now be extended and not bent to support the other arm. However, there is currently no evidence available to support a specific recovery position. Objectives: The aim of this study is to assess the impact of different recovery positions on perfusion of the forearm and associated comfort. Methods: In this cross-over randomized controlled trial, 24 healthy volunteers will be placed in either the lateral recovery position with extended dependent arm or with bent arm, and in the other position thereafter. Before and between both recovery positions, the volunteers will be positioned supine for 15 min. Several perfusion indices of the forearm will be non-or mildly invasively monitored in the respective recovery positions by radial artery tonometry, ulnar artery echo doppler and venous congestion plethysmography. Subjective participant's discomfort and pain will be assessed as well. Differences in continuous outcomes between the different recovery positions will be assessed with paired t-tests or wilcoxon signed-rank test. Discussion: The benefit of lateral positioning of adults and children with decreased level of consciousness has been widely accepted despite limited supportive scientific evidence. We here will provide direct evidence (i) whether venous drainage in the dependent limb is impaired when positioning the victim in the lateral recovery position with bent arms and (ii) whether this potential complication can be minimized by extending the dependent arm. The major limitations of this study is that healthy volunteers, instead of non-responsive victims, are included as participants, and that the study will be performed in a highly controlled environment. Nevertheless, the generated insights will directly fuel evidence-based treatment recommendations regarding the recovery position in first aid settings, and fill a current gap in evidence.

NCT ID: NCT05571254 Completed - Syncope Clinical Trials

The Management of Transient Loss of Consciousness and Suspected Syncope in European Emergency Departments

SEED
Start date: September 12, 2022
Phase:
Study type: Observational

Prospective multi centre cohort study examining the clinical presentation, diagnostic tests, and management of adult Emergency Department (ED) patients presenting with Transient Loss of Consciousness (TLOC) either undifferentiated or thought to be of syncopal origin.

NCT ID: NCT05521815 Completed - Clinical trials for Traumatic Brain Injury With Loss of Consciousness

Effect of Early Coma Arousal Therapy on Conscious Level Recovery and Cognition in Traumatic Brain Injury

Start date: August 23, 2022
Phase: N/A
Study type: Interventional

PURPOSE: The aim of this study is to investigate the effect of early coma arousal therapy on conscious level and cognitive function in sever traumatic brain injury patients. BACKGROUND: Traumatic brain injury (TBI) could be simply defined as an alteration in brain function due to external forces and is considered as one of the leading cause of death and disability worldwide, especially among young adults and the elderly. Current estimates imply that annual incidence of TBI is 50-60 million worldwide, and specifically for Europe and USA, 0.5% of Europeans and 1.1% of Americans are experiencing a TBI each year. The original scale has since been revised and is known as the Rancho Los Amigos Revised Scale (RLAS-R). One of the limitations of the original eight level scale was that it did not accurately reflect the individuals with higher levels of recovery. Two more levels were added to the initial eight level Ranchos Scale to create a more comprehensive ten level scale named the Rancho Los Amigos Revised Scale (RLAS-R).

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: 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: 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: 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).