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Unconsciousness clinical trials

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NCT ID: NCT02206152 Completed - Type 1 Diabetes Clinical Trials

A Randomized Double Blinded Study to Examine the Use of N-acetyl Cysteine for the Prevention and Treatment of HAAF in Patients With Type 1 Diabetes

NAC for HAAF
Start date: February 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single center, double blind randomized cross over design trial that will compare the impact of N-acetyl cysteine (200 mg) vs. saline infusion during experimental hypoglycemia on day one on the responses to experimental hypoglycemia on day two. 18 participants will be studied twice, 8 weeks apart. On each occasion they will undergo a 2 hour hypoglycemic clamp (target 50 mg/dl) in the morning and in the afternoon on day one and then again on the morning of day 2 and day 3. During the morning clamps, samples will be collected for later measurement of serum epinephrine levels, plasma and red blood cell NAC, cysteine, and glutathione concentrations and GSH/GSSG ratios (redox status), and participants will be asked to complete a hypoglycemia symptom questionnaire

NCT ID: NCT02146404 Completed - Clinical trials for Type 1 Diabetes Mellitus

The Effect of Hypoglycaemia on Brain Lactate Accumulation and Cerebral Blood Flow

Start date: August 2014
Phase: N/A
Study type: Interventional

Iatrogenic hypoglycemia is the most frequent acute complication of insulin therapy in people with type 1 diabetes (T1DM). Recurrent hypoglycemic events initiate a process of habituation, characterized by suppression of hypoglycemic symptoms and lead to hypoglycemia unawareness, which in itself defines a particularly high risk of severe hypoglycemia. Recent evidence suggest a pivotal role for increased brain lactate transport capacity in the pathogenesis of hypoglycemia unawareness. However, there is uncertainty about the magnitude of this effect and whether such excess brain lactate is oxidizes as a glucose-sparing alternative energy source or acts as a metabolic regulator controlling brain glucose metabolism, oxygen consumption and cerebral blood flow. Objective: The primary objective of this study is to investigate the effect of hypoglycemia on brain lactate accumulation and regional cerebral blood perfusion in humans. The secondary objective is to assess whether this effect is a related to hypoglycemia unawareness or a consequence of T1DM per se. Hypothesis: The investigators hypothesize that hypoglycemia stimulates lactate transport over the blood-brain barrier leading to cerebral lactate accumulation and that this lactate accumulation is a function of prior hypoglycemic exposure frequency contributing to clinical hypoglycemia unawareness. Furthermore, the investigators expect that this effect of hypoglycemia on brain lactate accumulation is related to changes in cerebral blood flow (CBF).

NCT ID: NCT02125214 Completed - Clinical trials for Loss of Consciousness

Alteration of Temporal Organization of EEG Microstate Sequences During Propofol-induced Loss of Consciousness

Fractal
Start date: January 2014
Phase: N/A
Study type: Interventional

Temporal dynamics of the EEG microstates show scale-free monofractal properties. This means that information is encoded in the same way at different scales. It may be postulated that these monofractal properties of the EEG microstate sequences constitute a necessary prerequisite of consciousness. We postulate that clinical variations of consciousness may also be linked to alterations of fractal properties of EEG microstates.

NCT ID: NCT01962285 Completed - General Anesthesia Clinical Trials

Neuronal Inertia in Propofol Anesthesia

INERTIA
Start date: August 2013
Phase: Phase 4
Study type: Interventional

Loss and recovery of consciousness during propofol anesthesia seem to be mediated by different mechanisms beyond the actual effect-site concentration of anesthetic drug. This eventual difference between dose response curves for loss of consciousness (LOC) and for recovery of consciousness (ROC) beyond hysteresis has received the name of neuronal inertia. We performed a volunteer-study comparing LOC and ROC curves during a slow, steady-sate, stepped target controlled infusion of Propofol. Our hypothesis is that, at steady-state conditions between plasma an effect-site concentration, there is still going to exist a difference between LOC and ROC, demonstrating the existence of neuronal inertia.

NCT ID: NCT01897688 Active, not recruiting - Type 1 Diabetes Clinical Trials

A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients

Start date: June 2012
Phase: Phase 3
Study type: Interventional

Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, specifically using Campath as induction, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.

NCT ID: NCT01787903 Completed - Clinical trials for Type 1 Diabetes Mellitus

The Effects of RT-CGM on Glycemia and QoL in Patients With T1DM and IHA

INCONTROL
Start date: February 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine what the effects are of real-time continuous glucose monitoring on glycemia and quality of life in patients with type 1 diabetes mellitus and impaired hypoglycemia awareness.

NCT ID: NCT01778608 Completed - Conscious Sedation Clinical Trials

Feasability Test of a Handset Device to Detect Levels of Sedation and Loss of Consciousness

Start date: January 2012
Phase:
Study type: Observational

Sedation is often administered to relieve anxiety and discomfort during uncomfortable procedures in elderly patients. Patient control of sedation offers many potential benefits for patients and healthcare professionals, including improved safety and patient satisfaction. The investigators overall goal is to develop a patient controlled intravenous sedation system that is effective but very safe for the patient, and requires minimal supervision by a doctor or nurse. To fulfill these criteria, a sedation system should incorporate fail-safe safety mechanisms. A key safety-critical component is a method of objectively assessing the degree of sedation of the patient, and of preventing him from self-administering unsafe doses of the sedative drug. The investigators have designed a new sedation system that uses a measure of the speed of response of the patient to a defined non-noxious stimulus to determine whether or not it is safe to allow him to self-administer further levels of sedation. Before being able to execute a volunteer study in order to determine a rational selection of optimal threshold response time, a feasibility test on the handset device is required.

NCT ID: NCT01768416 Completed - Clinical trials for Loss of Consciousness at End of Life

Measuring Depth of Unconsciousness at the End of Life Using Bispectral Index (BIS)

BISSOPS
Start date: March 1, 2013
Phase:
Study type: Observational

The purpose of this study is to use the BIS monitor to assess the degree of consciousness in pre-terminal palliative patients admitted to our palliative care unit and to ascertain if this tool provides a more accurate assessment of consciousness in this specific group of patients than clinical observation of consciousness and the use of sedation scales. We hypothesize that the measured BIS results provide a more accurate assessment of the patient's level of consciousness than routine clinical observation or the use of sedation scales.

NCT ID: NCT01730001 Withdrawn - Trauma Clinical Trials

Early Versus Late Intubation Trial in Physician Manned Emergency Medical Services

ELITE
Start date: January 1, 2015
Phase: N/A
Study type: Interventional

This study looks at advanced airway management in critically ill or injured patients treated by physician manned emergency medical services, comparing early (on-scene) intubation to late (emergency department) intubation.

NCT ID: NCT01721369 Completed - Clinical trials for Brief Loss of Consciousness

Applicability of Syncope Guidelines in Cataluña

SYNCAT
Start date: November 2011
Phase:
Study type: Observational

The aim of SYNCAT study is to study the level of adherence of the centers in Cataluña tu the Syncope Guidelines ESC2009 for the diagnosis and treatment of syncope and the impact that following them can have in the prognosis of these patients.