View clinical trials related to Constriction, Pathologic.
Filter by:The literature has shown evidence of the effectiveness of prehabilitation programs on post-operative recovery for musculoskeletal conditions; however, evidence for prehabilitation for lumbar spinal stenosis (LSS) is limited. Investigators have found that there is very low to low quality evidence for the effect of prehabilitation interventions for improving outcomes following lumbar spine surgery. Therefore, the purpose of this study will be to determine the feasibility of a prehabilitation program for patients undergoing LSS surgery, and pilot test the protocol to provide the foundation for future design of a larger, multicenter randomized controlled trial.
Pyloric stenosis is a current condition in pediatric surgery. The medical management prior to surgery consists of ionic correction. The nasogastric tube is commonly used to prevent gastric fluid inhalation before surgery, but there is no study on it benefits in this specific use. Other studies suggest that utilization of a gastric tube in pyloric stenosis may increase the duration of the medical treatment. The aim of the study is to evaluate the benefit of the nasogastric tube to prevent respiratory complications. This retrospective, monocentric and descriptive study include all patients hospitalized for pyloric stenosis in the university hospital in Amiens between 2014 and 2021. Patients with and without nasogastric tube prior to surgery are compared, regarding respiratory complications define as use of antibiotic, or oxygen therapy or infection in the lungs X-ray before surgery. The investigators analyze pre-operative data: vomiting, dehydration, time to ionic disorders correction and pain, and also notice the length of hospital stay. Data during hospitalization are analyzed and will be noticed the last medical contact represent by the post-operative consultation.
Liver transplantation (LT) is an essential treatment for end-stage liver disease. Although clinical outcomes of LT recipients have markedly improved, anastomotic biliary strictures (ABS) are still occurred in 10-40% of post-LT patients. In the Korea, living donor LT (LDLT) is the more common than deceased donor LT (DDLT). When LDLT is performed, the right lobe graft is usually used, and the right anterior and posterior segmental bile ducts (RASD/RPSD) of the graft are reconstructed by the duct-to-duct anastomosis method to the common hepatic duct of the recipient. When ABS occurs in LDLT recipients, the stricture site is often very tight and twisted. So, conventional endoscopic procedure is challenging and success rate of ERCP for ABS is still unsatisfactory (about 60%). Furthermore, approach to the RPSD is more intricate than that to RASD because the duct opening is located deeper in a posterior aspect. Therefore, despite being able to benefit the patient, bilateral drainage (both RASD and RPSD) is considered to be more difficult and unilateral drainage of RASD is mainly performed. In 2015, high-resolution cholangioscopy (SpyGlass™) was introduced. The system enables direct visualization of the bile and pancreatic ducts strictures. The 3rd Generation SpyScope DS II Access & Delivery Catheter introduced in 2018, features increased resolution and adjusted lighting to provide physicians with an even better view of the biliary and pancreatic ducts. To date, only several retrospective studies have evaluated the efficacy of SpyGlass for guidewire placement across the ABS and to the best of our knowledge only one prospective study is ongoing (ClinicalTrials.gov NCT #03205072). In that study ABS in both LDLT and DDLT patients are enrolled. Private communications with the Sponsor of this study, however, have reported that only approximately 10% of the cases are LDLT cases. In addition, there is no reported paper about the usefulness of Spyglass for bilateral drainage and its clinical benefit in post LT ABS. If successful bilateral drainage is performed by using Spyglass, it may be more helpful for patients than unilateral drainage as it allows sufficient drainage of the transplanted liver. With this prospective study, we intends to investigate the efficacy of Spyglass for bilateral drainage of ABS in LDLT patients and improve drainage success rate. This results can be used as clinical basis for further studies such as randomized controlled trial.
The WRAP Study aims to expand and understand the safety and efficacy data on the WRAPSODY Endoprosthesis System in a real-world population.
Transplant renal artery stenosis (TRAS) is abnormal narrowing of the main blood vessel to the kidney transplant and has historically been considered a surgical complication. In heart transplantation, it has long been recognised that rejection can cause narrowing of the heart's blood vessels, and that this complication is the leading cause of heart transplant failure. It is reasonable to assume that this process may also occur in kidney transplantation, which could contribute to premature transplant failure. However, in kidney transplantation it is also likely that other factors, such as surgical factors, traditional cardiovascular risk factors and immunological factors, contribute to the development of TRAS. Given that the disease processes that cause TRAS are not fully understood, at present there is no consensus among kidney doctors on the best means of treating patients diagnosed with TRAS. The aim of the proposed study is to investigate the involvement of these different processes in the development of TRAS, and investigate the optimal way to diagnose and manage TRAS. At present, there is no standard recommendation for how to treat patients with TRAS. This is partly due to the fact that patients with TRAS may have a broad array of symptoms: Some may have no symptoms, other may have problems with high blood pressure or fluid accumulation, and others may have severe transplant dysfunction. In most transplant centres, patient TRAS and severe symptoms will undergo IADSA and a stent will be placed to open the narrowing. However, it is not clear how best to manage patients with TRAS who have mild to moderate symptoms. We propose to recruit 36 such patients to a clinical study and split them into two groups: One group to undergo IADSA with possible stent placement, and one group to be closely observed. We will then compare transplant function, and other outcomes, after one year between the two groups.
In this multi-center prospective observational study within a cohort of symptomatic cerebral atherosclerotic stenosis (sCAS) patients, 850 subjects were planed to be enrolled to explore the relationship between cerebral autoregulation (CA) and stroke recurrence, determine the threshold values of CA parameter for predicting stroke recurrence associated with particular stenosis.
The study presents an alternative method of tracheal dilatation in pediatric patients with acquired tracheal stenosis. Dilatation is performed by the use of balloon catheter connected with manometer, that is bronchoscopic guided into trachea in the stenotic area, through the wide canal of supraglottic device i-Gel. Every dilatation cession consists of three consequent tracheal balloon dilatations of maximum 3 minutes duration each, followed by 10-15minutes interval of controlled ventilation. The balloon is inflated for 60 seconds to reach predefined pressure, and then deflated. This method is minimal traumatic for tracheal mucosa, and application of several dilatation procedures every 2-3months, in pediatric patients with acquired tracheal stenosis, may lead to a relative reopening of trachea and recession of clinical symptoms.For the right performance of the dilatation procedure, patients receive general anesthesia with cessation of spontaneous ventilation. During procedure, controlled ventilation-oxygenation is impossible, because the i-Gel canal is occupied by bronchoscope and balloon catheter, so patients will remain apneic for a short period of time. For pediatric patients is important to perform proper preoxygenation prior to procedure, and to maintain oxygenation as long as possible during procedure. This is achieved by application of apneic oxygenation, through a small catheter, connected to high flow oxygen. Participants are exposed during first dilation to no oxygenation, while during second and third dilatation to apneic oxygenation. Aim of the study is to investigate primarily whether application of apneic oxygenation, in pediatric patients during tracheal balloon dilatation, maintains regional cerebral oxygen saturation rSO2 in significant higher levels, compared with no application of oxygenation. rSO2 levels are a sensitive index of oxygenation efficacy of the brain, accordingly this refers to a safe procedure. Secondary issues are whether application of apneic oxygenation maintains pulse oximetry SpO2 and artierial oxygen partial pressure PaO2 in higher levels, and what are the effects on arterial carbon dioxide partial pressure PaCO2 and on haemodynamic parameters (heart rate, blood pressure), compared with no application of apneic oxygenation.
1. Introduction and aims: Transcatheter aortic valve replacement (TAVR) is the gold standard for the treatment of elderly patients with severe aortic valve stenosis (AS). AS causes left ventricular remodeling as well as left atrial enlargement, pulmonary artery and right ventricular changes, these changes, and whether they are reversible (reverse remodeling) are major determinants of outcome after TAVR. Heart Failure (HF) is the most frequent cause of cardiac re-hospitalization after TAVR. Most HF exacerbations are related to a progressive rise in cardiac filling pressures that precipitates pulmonary congestion and symptomatic decompensation. Traditionally, pulmonary congestion has been assessed by physical examination and chest radiography but clinical signs and symptoms of congestion are poor surrogates for ventricular filling pressures and are not reliable predictors of imminent hospitalization. Recently, lung ultrasonography (LUS) has been identified as a sensitive and semi-quantitative tool for the assessment of pulmonary congestion in HF. The technique is based on the detection of vertical echogenic artifacts arising from the pleural line, named "B-lines". The number of B-lines is associated with increased risk of adverse events during hospitalization and after hospital discharge. CLUSTER-HF Trial demonstrated that the routine incorporation of LUS during clinical follow-up of patients with recent acute decompensated HF without a surgically correctable cause, was associated with a risk reduction of adverse HF events, mainly urgent HF visits. Thus, LUS could represent a promising tool to detect pulmonary congestion related to AS. To date, there are no studies on the role of LUS in the context of AS and TAVR. The study hypothesis is that in patients with higher number of B-lines before-TAVR and after TAVR, the rate of adverse events during follow-up is higher. 2. Study design: This is a single center prospective study carried out at Fondazione Policlinico Gemelli IRCCS, Roma and involving patients with severe aortic stenosis submitted to TAVR treatment. The expected recruitment period is approximately one year For patients fulfilling inclusion/exclusion criteria, all data about clinical status leading to TAVR, exams and any specific documentation during hospitalization will be collected. 3. Number of patients: For the primary end-point, a sample-size of 91 is computed using the one-sample chi-square test and assuming a proportion of LUS-evaluated pulmonary congested patients before TAVR of 50% and a proportion of 35% of LUS-evaluated pulmonary congested patients after TAVR. To accommodate for possible missing investigations, sample size will be increased to 105 patients. The secondary end-point is the association between pre-TAVR and post-TAVR B-lines and long-term outcomes. Based on previous studies, the investigators know that the incidence of rehospitalization for heart failure during one-year after TAVR is 14% and that patients suffering from heart failure without LUS-evaluated pulmonary congestion are at very low risk of heart failure rehospitalization during follow-up. So, for sample size calculation of the secondary endpoint, the investigators estimated a cumulative incidence higher in the LUS- evaluated pulmonary congestion group with more than 16 B-lines on all scanning sites (30% of events during 1-year of follow-up) with a lower incidence of 8% in the remaining patients. With an HR of 5 favoring patients wit less than 15 B-Lines on all scanning, and aiming to a 2-sided alpha level of 0.05 and a power of 80% the investigators estimated 144 patients. To accommodate for possible missing investigations, sample size will be increased to 150 patients. 4. In-hospital study schedule: For each patient, the investigators will obtain from our general hospital database the following clinical data: - Demographic and clinical data documentation; - Clinical examination: before TAVR, before discharge and when adverse events occur; - Blood analysis; - TAVR procedural characteristics and complications. 5. Instrumental diagnostic exams (Echocardiography and lung ultrasound): Each patient will be evaluated before and after TAVR with a comprehensive echocardiogram and LUS for the evaluation of the pulmonary congestion. All the evaluations will be performed the day before TAVR and after TAVR. In consideration of the operator's dependence on ultrasound methods to reduce the error rate, all examinations will be performed by qualified personnel. 6. Clinical follow up assessment: Clinical follow up information will be obtained from: visits, review of the patient's hospital record, personal communication with the patient's physician and review of the patient's chart, a telephone interview with the patient conducted by trained medical personnel The following information will be recorded: clinical status assessment, adverse event assessment, record cardiac medications.
This study is designed to evaluate clinical outcomes and spine fusion rates for patients undergoing transforaminal lumbar interbody fusion using the CONDUIT 3D printed titanium TLIF cage.
When aortic valve-area is <1.0cm2 and transvalvular mean-gradient is >40mmHg, the diagnosis of severe aortic stenosis (AS) is straightforward. However, some patients present with an apparently reduced valve-area, despite transvalvular-gradient <40mmHg; Low-flow, low-gradient aortic stenosis (LFLG AS). When a patient with LFLG AS also presents with LVEF <50%, guidelines recommends performing a Low-Dose Dobutamine-echocardiography (LDDE) to confirm true-severe AS. However, nearly 30% of patients with LFLG AS do not show an adequate respond to Dobutamine. More commonly, patients present with the combination of LFLG AS, despite LVEF≥50%. In this group of patients the use of LDDE remains undisclosed. The purpose of this study is to examine the safety and diagnostic usefulness of LDDE in patients with LFLG AS with LVEF≥50%. Furthermore we will examine factors associated with inadequate response to LDDE. 150 symptomatic and/or asymptomatic patients with LFLG and LVEF≥50% and a control group with LVEF<50% will be enrolled at the Department of Cardiology, OUH. Patients will undergo clinical evaluation including LDDE, blood analyses, CT-scan and cardiac Mri. Only a limited number of studies examine the possible use of LDDE in patients with LFLG AS and LVEF≥50% and no study has been performed documenting the safety and feasibility.