Keelong Town, Taiwan
Mean Arterial Pressure After Out-of-hospital Cardiac Arrest
Phase
N/ASpan
183 weeksSponsor
Centre Hospitalier le MansDieppe
Recruiting
Simulation-based Training for Nurses and Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients
Currently, the technique of arteriovenous fistula puncture is transmitted by companionship within hemodialysis units. Although the main principles of the technique are well known and common to all hemodialysis units, strong rationales are still lacking to standardize fine practices such as the relative position of the needles, the angle of attack of the needle at puncture, the position of the bevel at the time of puncture and once the needle is in the vascular lumen. The training of professionals using a simulation-based training program on the approach to arteriovenous fistula puncture, in a process of optimizing practices and continuous improvement of care, while respecting the principles of andragogy, seems to be a suitable tool. This program is built in a multi-professional team from nephrology, nursing and health simulation. The aim of this study is to evaluate whether a simulation-based training program for nurses, concerning arteriovenous fistula puncture puncture, would allow to decrease the adverse events related to punctures. The investigators propose a prospective, comparative, randomized, multicenter study involving 8 hemodialysis centers. The primary objective is to compare the number of arteriovenous fistula puncture-related adverse events between: - A group receiving theoretical training + simulation-based training (4 centers) - A group receiving theoretical training only (4 centers) Will be included all adult patients who are to receive an arteriovenous fistula puncture puncture by a hemodialysis-trained IDE, during a scheduled chronic dialysis session. This study is innovative for several reasons: - simulation-based training in continuing education, among professionals is not widely used - simulation-based training in continuing education allows the conceptualization of the team approach to VF by its modeling in simulation - the evaluation of the direct benefit of the training on the patient, a Kirkpatrick level 4, is very little described in the literature. Thus, this study is of major interest to patients managed in nephrology with the simulation-based training tool.
Phase
N/ASpan
108 weeksSponsor
University Hospital, CaenDieppe
Recruiting
Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term
Inclusion Criteria - Adult patient (≥ 18 years old) who received one of FX Solutions Shoulder System for indication of hemi or total shoulder replacement. - Patient implanted between 2011 and 2015 with a minimum follow-up of 7 years - Patient has been informed of his participation in a clinical study and did not object to data collection - Patient insured with a social security system Exclusion Criteria - Patient who does not meet the inclusion criteria above - Protected adult - People deprived of their liberty Study Objectives - Primary Objective: To assess functional improvement according to the Constant score evolution compared to its preoperative value - Secondary Objectives, assessment of: To assess against the preoperative value: - the Subjective Shoulder Value score evolution - the American Shoulder and Elbow Surgeons shoulder score evolution To describe in real life - The complications rate - The long-term range of motion - The revision rates and the prosthesis survival curve Endpoints - Primary Endpoint will be the current Constant score (measured during the assessment). The functional improvement will be evaluated according to the evolution of this score compared to its preoperative value. - Secondary Endpoints: Current ASES and SSV scores Current range of Motion Revision rate at a long-term follow-up. Calculation of the survival rates The incidence of complications occurring since implantation Revision rates and survival rates of prostheses Study Groups Group 1: Subjects implanted with HUMELOCK I & II® Anatomic Shoulder System 2011 to 2013 Group 2: Subjects implanted with HUMELOCK II® Reversible System 2011 to 2013 Group 3: Subjects implanted with HUMELOCK Reversed® Shoulder System - 2012 - 2013 Group 4: Subjects implanted with EASYTECH® Anatomic Shoulder System - 2013 - 2014 Group 5: Subjects implanted with EASYTECH® Reversed Shoulder System (For Primary intention only) - 2013- 2014 Group 6: additional group for Subjects who were implanted with EASYTECH® Reversible Shoulder System (Exclusively for Revision of Easytech Anatomic) - 2013 -2014, if applicable Group 7: Subjects implanted with HUMERIS® Anatomic Shoulder System 2014 to 2015 Group 8: Subjects implanted with HUMERIS® Reversible Shoulder System 2014 to 2015
Phase
N/ASpan
30 weeksSponsor
FX SolutionsDieppe
Recruiting
Status Epilepticus in the Critically Ill Patients
Phase
N/ASpan
566 weeksSponsor
Ictal GroupDieppe
Recruiting
Healthy Volunteers
Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management
Phase
N/ASpan
315 weeksSponsor
Centre Francois BaclesseDieppe
Recruiting
Home Non Invasive Ventilation for COPD Patients
Phase
N/ASpan
735 weeksSponsor
University Hospital, RouenDieppe
Recruiting
Noninvasive 3D Mapping in Persistent Atrial Fibrillation, to Describe Modifications of the Arrhythmogenic Substrate After Pulmonary Vein Isolation and Identify Potential Predicting Factors of Ablation Success
Phase
N/ASpan
160 weeksSponsor
University Hospital, RouenDieppe
Recruiting
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Community-acquired pneumonia (CAP) that is of sufficient severity to require admission to an intensive care unit (ICU) is associated with substantial mortality. Patients with pneumonia who are being treated in an ICU will receive therapy that consists of many different treatments, as many as 20 or 30. These treatments act together to treat both the infection and its effects on the body. When treating a patient, doctors choose from many different treatments, most of which are known or believed to be safe and effective. However, doctors don't always know which treatment option is the better one, as individuals or groups of individuals may respond differently. This study aims to help doctors understand which treatments work best. This clinical study has been designed in a way that allows the information from patients already in the study to help new patients joining the study. Most studies aren't able to do that. REMAP-CAP has been designed to: - Evaluate multiple treatment strategies, at the same time, in the same patient. - Reach platform conclusions when sufficient data is accrued, rather than when a pre-specified sample size is reached - Utilise data that is already accrued to increase the likelihood that patients within the trial are randomised to treatments that are more likely to be beneficial - New questions can be substituted into the trial as initial questions are answered, meaning that the trial can be perpetual or open-ended - Interactions between interventions in different domains can be evaluated It is reasonable to presume that any pandemic respiratory infection of major significance to public health will manifest as life-threatening respiratory infection including Severe Acute Respiratory illness and severe Community Acquired Pneumonia (CAP) with concomitant admission to hospital, and for some patients, admission to an Intensive Care Unit (ICU). Previous pandemics and more localized outbreaks of respiratory emerging infections have resulted in severe CAP and ICU admission. Previous pandemics and outbreaks of emerging infectious diseases have outlined the urgent need for evidence, preferably from Randomized Controlled Trials (RCTs), to guide best treatment. However, there are substantial challenges associated with being able to organize such trials when the time of onset of a pandemic and its exact nature are unpredictable. As an adaptive platform trial that enrolls patients during the interpandemic period, REMAP-CAP is ideally positioned to adapt, in the event of a respiratory pandemic, to evaluate existing treatments as well as novel approaches.
Phase
3Span
621 weeksSponsor
UMC UtrechtDieppe
Recruiting
Role of PET Scan in the Evaluation of Early Response to Maintenance Treatment in Advanced Non-small-cell Lung Cancer
The purpose of the study is to optimize survival by an adapted metabolic imaging therapy in patients with advances non-small cell lung cancer. The primary objective of the study is to evaluate the role of SUV and metabolic volume measured by FDG PETScan in the early prediction of treatment response. 80 patients will be included in 2 years. They will be follow up for one year for monitoring the progression free survival.
Phase
2Span
278 weeksSponsor
Centre Henri BecquerelDieppe
Recruiting
(DIS)AGreement of Relatives Regarding Ethical End-of-life Decisions in ICU.
Context In the ICU, the vast majority of patients die following a life-sustaining therapies (LST) limitation decision. Most often, the patient is not able to express himself and has not made his wishes known beforehand, for example in the form of advance directives. The "relatives" are then the only recourse to state the patient's wishes, without any guarantee that they are aware of them. In France, the final decision is made by the physician (or the medical team) who is responsible for it. In this context, disagreements and even real legal conflicts on LST limitation decisions between relatives and physicians seem to be more and more frequent. To our knowledge, few data exist on the frequency of these disagreements over LST limitation decisions. Purpose The main objective of this study is to evaluate the frequency of disagreements between relatives and physicians over LST limitation decisions in adult intensive care. The secondary objectives are: - To assess the level of agreement/disagreement between family members and physicians regarding LST limitation decisions - To assess the proportion of disagreements experienced as conflictual - To assess the impact of the disagreement on the LST limitation decision (implementation of the decision, time between the decision and its implementation, length of hospitalization...) - To describe possible factors that contribute to disagreement and conflict - To describe national LST limitation decision-making practices.
Phase
N/ASpan
89 weeksSponsor
Société Française d'Anesthésie et de RéanimationDieppe
Recruiting