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Showing 1-13 of 13 trials
NCT06667999
Among critically ill patients, many die, and many of the survivors and their family members struggle for years with reduced quality of life. Critically ill patients are treated in intensive care units (ICUs). Here, they receive life support, e.g., mechanical ventilation and advanced support of the circulation (heart and blood vessels) and kidneys. In addition, ICU patients receive many other treatments. It is, however, uncertain if all the treatments provide value for the patients. The desirable effects of many treatments are uncertain, and some may be wasteful or even harmful. Clinical trials are necessary to validly assess the desirable and undesirable effects of different treatments. However, conventional clinical trials have limitations: * They typically only assess a single question related to a single comparison of treatments at a time. * They are often not very flexible, including with regards to the number of participants needed, and this increases the risk that a trial will end up as inconclusive. * There is no or limited re-use or sharing of infrastructure across trials, leading to duplicate work and resource use. * Trial participants do usually not benefit from the obtained knowledge before the trial concludes. * Involvement of patients, family members, and other stakeholders is typically limited, which may decrease the relevance of the questions addressed. With the Intensive Care Platform Trial (INCEPT), we aim to tackle these challenges by establishing a flexible platform trial that continuously learns from the obtained results. The platform trial may run forever with simultaneous and continuous assessment of many treatments. INCEPT will continuously learn from the accrued data and use these to improve the treatment of both participating and future patients. With INCEPT, we are also building a framework for thorough and extensive involvement of key stakeholders, including patients and family members. INCEPT will improve the way clinical trials are done and increase the probabilities that treatments are improved. This will: * Directly improve outcomes for ICU patients. * Relieve a strained healthcare system by discarding inefficient or harmful treatments. * Ensure that new treatments are beneficial or cost-effective before implementation. * Lower the costs and burdens of assessing more treatments in the critically ill.
NCT07098611
Liberation from mechanical ventilation involves three steps: weaning, readiness assessment, and extubation. Readiness is determined using clinical criteria such as improvement of the underlying condition, hemodynamic stability, and adequate respiratory effort. Successful extubation is defined as not requiring invasive support within 48 hours. Due to the complexity of ICU patients, various clinical parameters and multi-component scores have been developed to predict extubation success. This study aims to develop and evaluate a multi-component score, the Readiness for EXtubation score (REXs), to predict extubation readiness in ICU patients under invasive mechanical ventilation.
NCT06666647
The overall aim of this retrospective observational study is to investigate the association of emergency medical services response time with patient survival and treatment outcomes. The main question it aims to answer is: What is the association between response time and patient survival? The investigators will collect data for all patients who were treated by ambulance and/or helicopter services in Denmark and follow the patient's path from illness or injury to discharge from hospital with a focus on the significance of ambulance and helicopter response time.
NCT06627842
This is an ambispective observational study of patients admitted to intensive care with a diagnosis of joint prosthesis infection (mainly knee and hip prostheses). The main objective of the study is to describe the profile, care trajectories during the stay (before or after surgery) and prognosis of patients admitted to critical care with such an infection. We also aim to compare prognosis between different groups of patients sharing the same profile and care trajectory, and to assess independent risk factors associated with 2-year mortality among the study population. Finally, we will describe the microbiological and resistance profile of severe osteoarticular device infections requiring critical care admission in France. This is a descriptive and analytical observational study open to all French public and private hospitals. Patient data will be retrieved prospectively from patient source files. Only 2-year data (vital status, functional data) will be collected specifically for the study, by telephone contact with the patient or his or her support person.
NCT06946251
The aim of this study is to compare the effects of transcutaneous electrical diaphragm stimulation (TEDS) on diaphragm thickness, duration of mechanical ventilation, length of ICU stay, and right/left heart functions between patient groups with low and high ejection fraction (EF) levels. This randomized controlled trial will record demographic data, diaphragm ultrasound measurements, and echocardiographic findings of patients who receive or do not receive TEDS for five consecutive days. Participants will be divided into four groups according to their EF levels and whether or not they receive diaphragm stimulation: Group 1: Patients with low EF who receive TEDS Group 2: Patients with high EF who receive TEDS Group 3: Patients with low EF who do not receive TEDS Group 4: Patients with high EF who do not receive TEDS Diaphragm thickness and echocardiographic assessments will be performed at baseline and at the end of the five-day TEDS intervention. TEDS Application Protocol In the ICU, TEDS is administered by a physiotherapist once daily for 20 minutes, five days a week, as part of the routine treatment protocol. The stimulation is delivered using the LGT-231 model device from the LONGEST brand. A transcutaneous current with a frequency of 30-50 Hz and a pulse width of 300-400 microseconds is applied to the diaphragm. The stimulation intensity is increased until visible muscle contraction is achieved. Electrode placement involves: The first pair of electrodes placed bilaterally between the 8th and 10th anterior intercostal spaces, lateral to the xiphoid process. The second pair placed along the mid-axillary line of the thorax, also between the 8th and 10th intercostal spaces.
NCT06872697
Immobility and mechanical ventilation in intensive care unit (ICU) patients lead to muscle weakness and loss, particularly in antigravity and respiratory muscles. Early physiotherapy interventions are crucial to prevent complications, reduce side effects, shorten intubation time, and lower patient costs. ICU physiotherapy includes chest physiotherapy, range of motion exercises, strengthening exercises, mobilization, positioning, and inspiratory/peripheral muscle training. Muscle training plays a key role in ICU physiotherapy. Whole Body Vibration (WBV) is a promising, side-effect-free intervention to enhance muscle strength in various populations. Its effects result from neuromuscular responses to mechanical vibrations and the tonic vibration reflex. WBV has been reported to improve muscle strength, elasticity, circulation, and balance while reducing pain and fall risk. However, its effects on ICU patients remain unclear. To date, only one study has shown increased muscle electrical activity in ICU patients after WBV, but no research has evaluated changes in muscle strength, mass, or elasticity. Another method used in muscle training is neuromuscular electrical stimulation (NMES), which prevents muscle atrophy, strengthens muscles, and restores endurance. NMES is suitable for patients with limited cooperation, making it an alternative to active exercise. No study has compared NMES and WBV in immobile ICU patients. Given the limited non-pharmacological options in ICU care, particularly for unconscious or uncooperative patients, identifying effective alternatives is essential. This study aims to compare the effects of WBV and NMES on respiratory muscle strength, respiratory parameters, and muscle mass, composition, elasticity, and strength in ICU patients. Participants will be divided into three groups: WBV (n=15), NMES (n=15), and conventional therapy only (n=15). All groups will receive conventional therapy five days a week for four weeks, with WBV added to the first group and NMES to the second. Functional status, muscle assessments, grip strength, respiratory muscle strength, and respiratory parameters will be evaluated at baseline and study completion. The findings will provide objective data on the effectiveness of WBV and NMES in ICU patients, guiding future research and treatment while contributing to national and international literature.
NCT06733090
Ventilator-associated pneumonia (VAP) is a lung parenchymal tissue infection that develops nosocomially 48-72 hours after the start of mechanical ventilation (8, 15, 17, 23, 31). The second most common nosocomial infection in intensive care units in the United States is VAP (20). Approximately 90% of pneumonias developing in intensive care units are seen in patients receiving mechanical ventilation support, while the risk of VAP development is higher in the first days of hospitalization, and has been reported to be 3%/day in the first 5 days, 2%/day on the following six and ten days, and 1%/day on subsequent days (7, 20, 23,37). The concept of the Bundle of Care was first defined by the Institute for Healthcare Improvement in 2005 (21, 25). The Bundle of Care; It is a set of practices that have been beneficial in terms of clinical improvement, each of which includes 3-5 evidence-based, preventive interventions that contribute to the quality of care (5, 21, 25, 26, 30). There are studies in the literature showing that the use of the Care Bundle for the development of VAP reduces the rate of VAP development (5, 30, 34, 29, 28). Evidence-based practices frequently recommended in the literature within the scope of the VAP Care Bundle are; giving the patient a semi-fowler position (sitting at a 30-45 degree angle), evaluating daily extubation, evaluating daily sedation, peptic ulcer prophylaxis unless contraindicated, and deep vein thrombosis prophylaxis (15, 21, 23, 26, 28, 30). Health Care Improvement Institute; recommends washing hands before and after patient contact, removing subglottic secretions, and not changing ventilator circuits earlier than 48 hours (19, 21, 32, 33). In addition to evidence-based practices, the Institute for Health Care Improvement recommends that oral intubation be preferred to nasotracheal intubation, endotracheal tube cuff pressure should be between 20-30 cmH2O, enteral feeding should be initiated within 24-48 hours for hemodynamically stable intensive care patients, oral care should be performed with an antiseptic solution at 2-12 hour intervals, including teeth, cheeks, and tongue, monitoring humidifier filters and irrigation solutions, and aspiration should be performed under appropriate conditions. These interventions are considered evidence-based (1, 2, 3, 8, 9, 10, 11, 12, 14, 16, 18, 22, 23, 26, 33). The evidence-based Care Bundle Interventions to be implemented by the researcher within the scope of this study are listed below. Interventions to be implemented by the nurse's decision include; Oral care with 0.12% chlorhexidine glucanate or 0.2% chlorhexidine glucanate solution, 4 times a day, at 6-hour intervals, semi-fowler position (sitting at a 30-45 degree angle) unless contraindicated, monitoring the endotracheal tube cuff pressure to be between 20-30 cmH2O, changing ventilator circuits and humidifier filters in case of visible contamination or malfunction, and monitoring the aspiration application. Interventions to be implemented by the physician's decision include; includes daily extubation assessment, peptic ulcer prophylaxis unless contraindicated, deep vein thrombosis prophylaxis unless contraindicated.
NCT06609564
In addition to conventional chest physiotherapy, inspiratory muscle training will be applied in mechanically ventilated intensive care patients. It is aimed to examine the effects of inspiratory muscle training on respiratory muscle strength, diaphragm thickness, and diaphragm excursion in intubated or tracheostomized patients with mechanical ventilation in the intensive care unit.
NCT05026255
Assessment of preload dependency via measurement of peripheral venous pressure during an alveolar recruitment manoeuvre. Prospective multicentre open-label study of mechanically ventilated intensive care patients.
NCT04169204
Shock is a frequent, etiologically heterogeneous and often lethal clinical condition of intensive care medicine. This is particularly true for very old intensive care patients (VIPs), who are among the fastest-growing subgroups of all intensive care unit (ICU) patients and who suffer from a significantly impaired outcome. In addition to the treatment of the causes of shock, current therapeutic approaches focus on the stabilization of vital parameters, which in general all reflect macrocirculatory measured values such as blood pressure. In contrast, a disturbance of the microcirculation (blood circulation of the smaller blood vessels \<100 µm) is only poorly measurable and delayed. The last generation of AVA-Software (MicroVisionMedical) will calculate different parameters about the capillary densitiv and perfusion in a user-independent way. VIPPER investigates whether a non-invasive measurement of microcirculation using the sublingual mucosa in very old intensive care patients in shock leads to faster recognition and specific treatment of organ dysfunctions. Secondly, this study checks whether this measurement predicts outcome.
NCT06078826
Patients hospitalized in tertiary intensive care units are connected to mechanical ventilators due to multiorgan failure, chronic diseases, respiratory failure, etc. Endotracheal aspiration is then necessary to maintain respiratory patency. However, patients feel a lot of pain during this application. Pharmacological methods for pain relief are mostly used in intensive care units. These methods can have many complications. In this study, it was aimed to determine the effect of passive music therapy and foot massage, which are non-pharmacological methods, on hemodynamic status in relieving pain and anxiety that may develop due to this. Reducing the use of pharmacological methods and switching to non-pharmacological methods in pain relief will increase the quality of patient care and recovery results. This research will be conducted as a prospective, randomized controlled, single-blind, experimental. In the study, passive music therapy will be applied to one of the intervention groups and foot massage will be applied to the other in the tracheal aspiration process, and no application will be made to the control group. Passive music therapy and foot massage will be applied for 30 minutes during the tracheal aspiration procedure. Evaluation will be made before, during and after the application. When the literature is examined, there are few studies examining the effect of foot massage in intensive care patients, but no studies evaluating the effect of foot massage during the aspiration procedure have been found. For this reason, it is thought that passive music therapy and foot massage applied in the aspiration process in intensive care patients will reduce the level of pain and anxiety, thus positively affecting the hemodynamic status of the patient, increasing the comfort of the patient and improving the results of nursing care. Thus, it is planned to bring an original study that has not been done on the subject to the literature.
NCT03137589
Telemedicine allows providing expert know-ledge from specialized health centers to regional hospitals and practices. In this multicenter, prospective, non-interventional study hospitals and practices in NRW are supplied via a telematics platform with expertise from the university hospitals RWTH Aachen and Münster. The communication occurs via highly encrypted audio/video conference systems and a certified data exchange platform "Fallakte+". In total 40.000 outpatient and stationary patients with infectious diseases or need for intensive care should be treated with telemedical support. The participating hospitals and practices are randomly distributed into four clusters. The clusters are supplied with telemedicine at different time points but all clusters start at the same time collecting data from patient cohorts of infectiology and intensive care (e.g. symptom, therapeutic progress and outcome). The collected data is later compared to data obtained in the same way from patients treated with telemedical support and evaluated regarding differences in the quality of treatment, therapeutic process and the satisfaction of the patients with telemedicine. The aim is to improve the treatment quality in regional hospitals and practices of patients with serious and complex diseases and bring forward the application of telemedicine.
NCT01523665
Glucose metabolism is impaired in many critically ill patients and is often aggravated by parenteral feeding, infections and/or pre-existent diabetes.Therefore insulin infusion protocols, which are based on frequent bedside glucose monitoring, have been implemented on most critical care units. Despite extensive efforts of the intensive care unit staff difficulties were experienced in achieving efficient and safe glucose control. Several barriers to the implementation of glycemic control have been identified. Most importantly, there is concern about increased frequency of severe hypoglycemic episodes. To overcome these problems Space GlucoseControl was developed as a decision support system which helps to achieve safe and reliable blood glucose control in the desired ranges (4.4 - 6.1 mmol/l or 4.4 - 8.3 mmol/l). The objective of this non-interventional study is to gain additional information on the performance of the Space GlucoseControl system for glycaemic control in ICU patients when used in routine clinical practice.