View clinical trials related to Exacerbation of COPD.
Filter by:Goal of the study: To show that prehospital NPPV use for COPD decompensation, as compared to only standard medical treatment, might enable a decrease in intubation rate. Primary end point: the rate of endotracheal intubation in the first three hours after randomization. Secondary en points: rate of endotracheal intubation after third hour, rate of prehospital and ICU mortality, ICU days, effects on clinical parameters (respiratory rate, SpO2, heart rate, arterial blood pressure, consciousness) and arterial blood gases (pH, PaCO2, PaO2), 30 days mortality, delays between first medical contact and in-hospital admission, relation between initial pH level and endotracheal intubation. Inclusion criteria: Adult patients (>18 years), with GCS≥10, known or suspected COPD and presenting acute respiratory decompensation with respiratory acidosis. Exclusion criteria: Cardiac or respiratory arrest, upper gastro intestinal tract haemorrhage, shock, serious ventricular arrhythmia, severe sepsis, multiple organ failure, serious cranial-facial trauma, upper airways obstruction, undrained pneumothorax, uncooperative-agitated patients refusing the technique, respiratory distress with bradypnoea < 12/min, pauses gasps repeated bradycardia, intractable vomiting, acute traumatic tetraplegia, persistant hemodynamic instability with PAS<90mmHg, ensuitable environment. Randomization: Assignment to NPPV group or standard therapy group will be performed at the time of arrival of the SAMU team to the patient, by calling a physician located at the calldispatch center who will connect to the web site of the clinical research unit from Bordeaux university hospital. Period of study: 25 months (24 months for patients inclusion and 1 month for follow-up). Number of patients: 199 patients in each group i.e 398 patients (significance level of 5%, power of 80%; 50% expected decrease of intubation rate, i.e. from 20 to 10%). Main investigator: Dr Pierre-Arnaud Fort, MD, Pôle Urgences-SAMU47-Réanimation, Centre Hospitalier Saint-Esprit - Agen. Participating centers : 20 SAMU-SMUR corresponding to 19 departments in France.
In response to the European regulatory authorities, GSK is conducting a post-marketing observational study to assess the efficacy of Relenza when used as prophylaxis against influenza. SPECIFIC AIMS 1. Determine the frequency of patients who received Relenza from October 2006 through April 2009, and among them the number who have no concurrent diagnosis of influenza, i.e., those receiving Relenza for prophylaxis, and among these the number who have a family member with a medical visit for influenza within three days preceding the above indentified patient's dispensing of Relenza. This is to determine the feasibility of conducting detailed analysis. 2. If analysis is feasible then tabulate the frequency of influenza-like-illness and respiratory outcomes in users of prophylactic Relenza and their family members and in family members of persons using Relenza for the treatment of influenza (i.e., index cases). 3. If analysis is feasible then estimate the direct effect of prophylactic Relenza on the occurrence of influenza-like-illness and respiratory outcomes, the secondary effect of Relenza treatment of influenza on susceptible family members, and the total effect of Relenza (treatment plus prophylaxis). METHODS Overview of Study Design This is an analysis of the 30-day risk of influenza-like illness and respiratory outcomes in persons for whom some household members (index cases) have had a medical visit associated with a diagnosis of influenza. The exposed individuals to the index case will be categorized into one of four cohorts according to whether the exposed person received prophylactic Relenza or no antiviral treatment and by whether the index family member with a diagnosis of influenza received antiviral treatment. Estimates of the direct effect of Relenza prophylaxis, the indirect effectof preventing disease in susceptible family members, and the total effect of disease reduction when both index cases and susceptible family members are treated will be obtained from different comparisons between cohorts, as outlined below. The research will cover the first three influenza seasons during which Relenza has been indicated for prophylactic use in the United States. These will be from October through April of 2006-2009.
Aim of the study is to assess feasibility and safety of a public territorial radiology service for home hospitalized frail elderly patients whose health conditions discourage the transportation to hospital.