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NCT ID: NCT04772547 Completed - Coma Clinical Trials

VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa

VIGAB-STAT
Start date: September 22, 2021
Phase: Phase 2
Study type: Interventional

This is a pilot trial of a single loading dose of vigabatrin in post-anoxic status epilepticus.

NCT ID: NCT04653597 Completed - Poisoning Clinical Trials

Non-invasive Airway Management of Comatose Poisoned Emergency Patients

NICO
Start date: May 16, 2021
Phase: Phase 3
Study type: Interventional

A decreased level of consciousness is a common reason for presentation to the emergency department (ED) and is often the result of intoxication (up to 1% of all ED visits and 3% of ICU admission). In France, approximately 165 000 poisoned patients are managed each year. Originally developed in head injured patients, the Glasgow Coma Scale (GCS) is a validated reproducible score evaluating the level of consciousness: a GCS ≤ 8 is strongly associated with reduced gag reflex and increased incidence of aspiration pneumonia. Although recommended for patients with traumatic brain injury and coma, it remains unknown whether the benefit of an invasive management of airways with sedation, intubation and mechanical ventilation should be applied to other causes of coma in particular for acute poisoned patients. The investigator hypothesize that a conservative management with close monitoring without immediate endotracheal intubation of these patients is effective and associated with less in-hospital complications (truncated at 28 days) compared to routine practice management (in which the decision of immediate intubation is left to the discretion of the emergency physician).

NCT ID: NCT04519268 Completed - Surgery Clinical Trials

Adherence Degree of Kasr-Alaini Hospital Pre-anesthetic Tests to the NICE-UK Guidelines

Start date: August 20, 2020
Phase:
Study type: Observational

Routine preoperative tests aim to identify asymptomatic diseases that can't be recognized by history and examination. Identification and management of these diseases is thought to help minimizing perioperative morbidity and mortality. A large number of routine screening tests increase the cost of perioperative care. Also unneeded tests may harm the patient due to overtreatment for borderline / false positive results. Therefore, the routine use of such examinations remains controversial. The National Institute of Health and Clinical Excellence (NICE-UK) guidelines for preoperative examination are the assessment standard developed by NICE in collaboration with the National Collaboration Center for Acute Care in the UK; in order to reduce unnecessary tests by recommending which tests should be offered to people before minor and major operations. The aim of this study is to assess the degree of adherence of the current preoperative tests at Kasr Alaini hospital to the NICE guidelines, to assess the effectiveness and usefulness of the current practice of various examinations ordered by anesthesiologists during the pre-anesthetic evaluation in patients who are intended for elective surgery in the hospital and to also evaluate the cause of delay & its effect to predict postoperative complications.

NCT ID: NCT04476589 Completed - Covid19 Clinical Trials

Prognostication of Recovery in Early Disorders of Consciousness After COVID-19

PREDICT-COVID
Start date: July 1, 2020
Phase:
Study type: Observational

The primary aim of this research proposal is to use multimodal metrics (e.g., clinical data and advanced neuroimaging) in the early (i.e., acute hospitalization) phase of recovery from COVID-19-related disorders of consciousness to predict outcome at 3, 6, and 12 months post-hospitalization. We aim to construct an algorithm that synthesizes the results of these metrics to help predict recovery.

NCT ID: NCT04323020 Completed - Cardiac Arrest Clinical Trials

CT Perfusion (CTP) for Assessment of Poor Neurological Outcome in Comatose Cardiac Arrest Patients

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

ABSTRACT Brief Overview: Neurological assessment of comatose cardiac arrest patients (CCAP) is challenging because most of these patients are treated with sedatives and therapeutic hypothermia that prevent complete neurological/clinical assessment. A complete and reliable neurological assessment is needed for patient's long-term function and survival. A poor-quality clinical assessment results in resource-intensive treatment that may not benefit the patient. An ancillary test of head CT scan is often used for additional information. However, this additional information still limits the quality of the assessment. In a small pilot study, we explored an advanced CT scan of brain called CT Perfusion (CTP) relative to clinical assessment in CCAP as a predictor of neurological outcome (severe disability or death) at hospital discharge. The preliminary results suggested that CTP was both valid and reliable, relative to clinical assessment, while meeting many of the criteria of an ideal test (fast, safe, accessible, valid, reliable). This project aims to carry out a fully powered study to confirm these findings. The goal of this project is to validate CTP for predicting neurological outcome at hospital discharge in CCAP. We will conduct a prospective cohort study to validate the use of CTP in CCAP. Hypothesis- Computed Tomographic Perfusion (CTP) can reliably diagnose potentially fatal brain injury in CCAP in early stage upon hospital admission, which may or may not be recognized in the usual clinical practice due to inadequate clinical examination. Primary Objective: To validate CTP, relative to the reference standard of clinical assessment, for characterizing poor neurological outcome at hospital discharge in CCAP. Secondary Objectives: To establish the safety and inter-rater reliability of CTP in CCAP.

NCT ID: NCT04219735 Completed - Delirium Clinical Trials

Effect of Minocycline on Delirium Incidence in Critically Ill Patients

Start date: January 30, 2020
Phase: Phase 2
Study type: Interventional

Delirium is a disorder of consciousness characterized by an acute onset and fluctuating course of impaired cognitive functioning. It is associated with unfavorable outcomes in hospitalized patients, including longer hospital length of stay, need for subsequent institutionalization and higher mortality rates. Patients in the intensive care unit (ICU) under mechanical ventilation and older age are at higher risk for the development of delirium. Several studies suggest that minocycline, through its anti-inflammatory effect, was able to prevent neuronal dysfunction in different models of ICU-related diseases. Thus, the present study aimed to evaluate the effect of minocycline on delirium development in critically ill patients. Patients will be randomized into one of two groups: the intervention group that will receive 100mg of minocycline 2 times a day and the placebo group. Medication or placebo will be continued for 28 days or until ICU discharge (whichever occurs first). Delirium will be diagnosed by the CAM-ICU. Coma will be defined by the Richmond Agitation-Sedation Scale (RASS) score of -4 or -5 and biomarkers will be used as alternative outcomes related to the pathophysiology of the disease (IL-1, IL-6, IL-10, and BDNF).

NCT ID: NCT03926494 Completed - Coma Clinical Trials

Carbon Monoxide-induced Coma: Prognostic Factors

Coma-CO
Start date: May 1, 2019
Phase:
Study type: Observational

The primary objective of the study is to determine prognostic factors for hospital-mortality following carbon monoxide (CO)-induced coma. The secondary objective is to determine prognostic factors of CO related cognitive sequelae, at the time of hospital discharge.

NCT ID: NCT03814356 Completed - Coma Clinical Trials

Stimulant Therapy Targeted to Individualized Connectivity Maps to Promote ReACTivation of Consciousness

STIMPACT
Start date: August 24, 2020
Phase: Phase 1
Study type: Interventional

Phase 1 of the STIMPACT trial is an open label,dose-escalation,safety study of intravenous (IV) methylphenidate (MPH) therapy in patients with disorders of consciousness (DoC) caused by severe brain injuries. To be classified as having a DoC, a patient must be in a coma, vegetative state (VS), or minimally conscious state (MCS), as determined by behavioral assessment using the Coma Recovery Scale-Revised (CRS-R). Patients with DoC admitted to the intensive care unit (ICU) will be eligible for the study. A total of 10 patients with DoC will be enrolled in the Phase 1 study. Patients will receive escalating daily doses of IV MPH starting at 0.5 mg/kg, increasing stepwise to 1.0mg/kg and 2.0 mg/kg unless an adverse event (AE) necessitates dose de-escalation or a serious adverse event (SAE) necessitates that the patient stop participation in the study. Pharmacokinetics will be evaluated in selected patients with indwelling venous catheters or arterial catheters via serial serum measurements of MPH at each dose. The pharmacodynamic properties of IV MPH at each dose will be assessed by comparison of pre-versus post-dose EEG-based measures. The pharmacodynamic properties of the maximum tolerated dose will also be assessed by comparison of pre-versus post-dose resting state functional MRI (rs-fMRI) connectivity measures. Finally, we will test the association between structural connectivity of the ventral tegmental area (VTA), a dopaminergic brainstem nucleus that is believed to mediate MPH activation of the cerebral cortex, and EEG and rs-fMRI pharmacodynamic measures.

NCT ID: NCT03737747 Completed - Clinical trials for Prediction by the Synek Score of Poor Neurological Outcome in Postanoxic Comatose Patients Treated With Induced Hypothermia

Synek Score to Predict Poor Neurological Outcome Post Resuscitated Cardiac Arrest

Start date: November 1, 2013
Phase:
Study type: Observational

Resuscitated cardiac arrest (CA) is a frequent cause of admission in intensive care unit (ICU). Neurological state of postanoxic comatose patients can evolve either towards the absence of awakening or towards a more or less altered state of consciousness, ranging from the vegetative state to the full recovery of cognitive functions. Most of the deaths result from active withdrawal of life-sustaining treatment, based on poor neurological outcome prediction. Neurological prognostication needs therefore a multimodal approach based on reliable parameters, which should be easy to access and available at the early stage of care, in attempt to limit false poor outcome prognostication and help to not prolong futile active care in patient with severe post anoxic cerebral lesions. Nowadays the prediction of neurological outcome relies on a multimodal strategy including clinical examination, biomarkers and electroencephalography (Guidelines ESICM 2015). Early standard electroencephalography (EEG) is currently recommended and some features, notably absence of reactivity, status epilepticus or burst suppression after rewarming are strongly predictive of poor outcome. But those features require a precise analyze of the EEG usually performed by specialist. EEG patterns can be simplified and classified in five grades according to the Synek classification, ranging from dominant reactive alpha activity (grade 1) to isoelectric encephalogram (grade 5). Grade 1 and two are considering as good prognostic, grade 3 as intermediate and grade 4 to five as poor prognostic. Nevertheless, few data are available on the performance of this classification since generalization of TTM use. We hypothesize that a multimodal strategy combining clinical examination, NSE concentration and the Synek score would bring a high degree of prediction. We aimed to assess the performances of the combination of clinical examination, NSE analysed at 48-72h and the Synek score to predict hard outcome defined by a cerebral performance category (CPC) 3-5, in postanoxic comatose patients treated with induced hypothermia

NCT ID: NCT03616054 Completed - Critical Illness Clinical Trials

International Observational Study on Airway Management in Critically Ill Patients

INTUBE
Start date: October 1, 2018
Phase:
Study type: Observational

Endotracheal intubation (ETI) is a potentially life-threatening procedure for critically ill patients and major severe complications such as severe hypoxia, cardiovascular collapse and cardiac arrest are common. Despite the high risk of the procedure, different interventions lack high-quality evidence and the investigators hypothesize that a heterogeneous practice among different centres and geographical areas may be found. The investigators designed a large international observational study aiming at prospectively collecting data on the current impact of ETI-related adverse events and current airway management practice in critically ill patients. Investigators will collect data on all consecutive in-hospital (intensive care unit, emergency department and wards) ETIs performed in adult critically patients.