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NCT07071935
Amyotrophic lateral sclerosis (ALS) is a disease that causes weakness of the muscles of the body. The disease can eventually lead to severe breathing problems, which is the most common cause of death from ALS. The treatment for breathing is non-invasive ventilation (NIV). It is a machine that helps a person breathe by pushing air in and out of their lungs through a mask worn over the face. Research has shown that NIV can improve the quality of life and survival of someone with ALS. Unfortunately, NIV is not equally beneficial for everyone. The investigators do not yet know the best time or method for starting NIV in ALS. Europe and Canada allow starting NIV much earlier in ALS than the United States. Current recommendations for starting NIV are based on the opinion of experts rather than large research studies. Medical insurance companies will not cover NIV until significant breathing weakness occurs. After NIV is started, there is no evidence-based guidance on the best way to adjust NIV to benefit patients as much as possible. Some patients have difficulty tolerating NIV, but it is not clear how to identify these individuals ahead of time. The investigators have created a new prediction tool that can identify patients at high risk of breathing problems within the next 6 months. This may help the study team identify who is more likely to benefit from starting NIV early. The investigators have published a paper that shows that NIV helps people with ALS live longer. This paper also showed that patients get more benefit with use NIV for at least 4 hours per day. The investigators published another paper that measured a gas called carbon dioxide (CO2), which goes high if someone's breathing is weakened. This paper showed that patients with ALS may live longer when CO2 levels are lowered using NIV. The investigators also have data suggesting that certain characteristics may predict who is less likely to use NIV at least 4 hours per day. In this study, the investigators will collect pilot data on starting early NIV in individuals with ALS who do not yet meet insurance criteria for covering NIV. The research team will first use their previously published prediction tool to identify patient risk. Then, subjects would be randomized to start early NIV or to usual care. The usual care group would eventually start NIV as would occur if the participants were not in the study. The purpose of this study is to collect data to help the investigators plan a larger randomized clinical trial. This study has 4 objectives. First, the project aims to identify individuals who would benefit from earlier NIV. The research team will use the original prediction tool to identify risk of severe breathing problems within the next 6 months. Second, the project aims to show that it is feasible to start NIV early. Third, the project aims to gather data on the effect of randomization on symptoms, CO2 levels, and outcomes. Fourth, the project aims to identify traits that may make someone less likely to use NIV.
NCT07228676
High-flow nasal oxygen (HFNO) is recommended as first-line treatment to prevent intubation in acute hypoxemic respiratory failure and to prevent reintubation after extubation. Accumulating data suggest that strong inspiratory efforts and their persistence are associated with HFNO failure. However, tools to monitor continuously and noninvasively inspiratory efforts are lacking. The investigators have developed an algorithm estimating noninvasively inspiratory efforts under HFNO. This pilot study aims at testing the feasibility of estimating inspiratory efforts in patients treated with HNFO.
NCT05904652
The goal of this feasibility study is to learn whether a new approach to breathing tube removal within the Intensive Care Unit is safe and acceptable to participants who require a breathing tube for the management of severe breathing difficulties. The main questions it aims to answer are: * What is the recruitment rate to the study over 12 months? * Is the study design acceptable and safe to participants? Participants will receive high flow nasal oxygen before their breathing tube is removed. The investigators will compare this with standard practice of applying conventional, low-flow oxygen after the breathing tube removed to see if this effects the rate of repeat breathing tube insertion. The investigators hypothesise that they will recruit 30 participants to the study protocol (15 participants in each group) over 12 months and that our study protocol will be tolerable and acceptable to participants.
NCT07468006
Transcutaneous capnometry (tPCO₂) is a non-invasive method for continuous monitoring of ventilation status. In pediatric intensive care patients, it may reduce the need for repeated arterial or arterialized blood sampling. However, the accuracy of tPCO₂ may be influenced by factors such as peripheral perfusion, skin temperature, and vasopressor therapy. This prospective observational study compares transcutaneous carbon dioxide measurements with arterialized or arterial blood gas PaCO₂ values in children with respiratory insufficiency, including a subgroup receiving vasopressor support.
NCT07422441
People undergoing repair of large ventral hernias can develop breathing problems after surgery, especially around the time when the abdominal wall is closed. During closure, pressure inside the abdomen may increase and lung mechanics can worsen. This study will evaluate a structured intraoperative decision approach that uses standard anesthesia measurements of static respiratory system compliance at predefined timepoints to support the choice of abdominal wall closure technique. The main goal is to assess the rate of early postoperative respiratory failure within 72 hours after surgery.
NCT05440851
PRACTICAL is a randomized multifactorial adaptive platform trial for acute hypoxemic respiratory failure (AHRF). This platform trial will evaluate novel interventions for patients with AHRF across a range of severity states (i.e., not intubated, intubated with lower or higher respiratory system elastance, requiring extracorporeal life support) and across a range of investigational phases (i.e., preliminary mechanistic trials, full-scale clinical trials). AHRF is a common and life-threatening clinical syndrome affecting millions globally every year. Patients with AHRF are at high risk of death and long-term morbidity. Patients who require invasive mechanical ventilation are at risk of ventilator-induced lung injury and ventilator-induced diaphragm dysfunction. New treatments and treatment strategies are needed to improve outcomes for these very ill patients. Utilizing advances in Bayesian adaptive trial design, the platform will facilitate efficient yet rigorous testing of new treatments for AHRF, with a particular focus on mechanical ventilation strategies and extracorporeal life support techniques as well as pharmacological agents and new medical devices. The platform is designed to enable evaluation of novel interventions at a variety of stages of investigation, including pilot and feasibility trials, trials focused on mechanistic surrogate endpoints for preliminary clinical evaluation, and full-scale clinical trials assessing the impact of interventions on patient-centered outcomes. Interventions will be evaluated within therapeutic domains. A domain is defined as a set of interventions that are intended to act on specific mechanisms of injury using different variations of a common therapeutic strategy. Domains are intended to function independently of each other, allowing independent evaluation of multiple therapies within the same patient. Once feasibility is established, Bayesian adaptive statistical modelling will be used to evaluate treatment efficacy at regular interim adaptive analyses of the pre-specified outcomes for each intervention in each domain. These adaptive analyses will compute the posterior probabilities of superiority, futility, inferiority, or equivalence for pre-specified comparisons within domains. Each of these potential conclusions will be pre-defined prior to commencing the intervention trial. Decisions about trial results (e.g., concluding superiority or equivalence) will be based on pre-specified threshold values for posterior probability. The primary outcome of interest, the definitions for superiority, futility, etc. (i.e., the magnitude of treatment effect) and the threshold values of posterior probability required to reach conclusions for superiority, futility etc., will vary from intervention to intervention depending on the phase of investigation and the nature of the intervention being evaluated. All of these parameters will be pre-specified as part of the statistical design for each intervention trial. In general, domains will be designed to evaluate treatment effect within four discrete clinical states: non-intubated patients, intubated patients with low respiratory system elastance (\<2.5 cm H2O/(mL/kg)), intubated patients with high respiratory system elastance (≥2.5 cm H2O/(mL/kg)), and patients requiring extracorporeal life support. Where appropriate, the model will specify dynamic borrowing between states to maximize statistical information available for trial conclusions. In this perpetual trial design, different interventions may be added or dropped over time. Where possible, the platform will be embedded within existing data collection repositories to enable greater efficiency in outcome ascertainment. Standardized systems for acquiring both physiological and biological measurements are embedded in the platform, to be acquired at sites with appropriate training, expertise, and facilities to collect those measurements.
NCT06510972
Fasting in intensive care is mainly studied in mechanically ventilated patients or those in the weaning phase. Recent research challenge the common assumption of fasting and suggests that continuing enteral nutrition before extubation may be beneficial. Fasting is also practiced before procedures (e.g., tracheostomy, endoscopy) or surgeries, based on anesthetic guidelines. Yet, no data address fasting in non-intubated ICU patients with acute respiratory failure, despite frequent caloric deficits and inadequate nutritional intake. Aspiration risk often justifies fasting, but studies indicate that swallowing reflexes remain intact in patients receiving high-flow nasal oxygen or non-invasive ventilation. Moreover, although intubation carries a 2-5.9% aspiration risk, rapid sequence induction mitigates this, questioning the necessity of preventive fasting. Despite its prevalence, this practice lacks scientific validation and guideline support. Patient discomfort is also significant. Hunger and thirst are major sources of distress, and evidence from anesthesiology suggests that allowing fluid intake pre-anesthesia reduces discomfort. Extrapolating these findings to ICU patients could improve well-being. In conclusion, fasting in ICU patients may contribute to discomfort, dehydration, and malnutrition, while its protective benefits remain uncertain. We hypothesize that maintaining oral intake does not increase the risk of intubation or aspiration-related complications.
NCT07391150
Non-invasive ventilation (NIV) is the delivery of breathing support via a facemask. It is used to treat people whose natural breathing is ineffective. Evidence shows that, when used long-term, it improves both quality of life and life expectancy. Ventilation is delivered in the home through a mask covering the nose or the nose and mouth. A good fit between the mask and the patient's face is essential to deliver the treatment effectively. Mass-produced masks are available for the adult market but in children it is often difficult to find a mask that provides an adequate fit. A particularly disadvantaged group is children with facial deformities or facial asymmetry. In these groups NIV may not be possible due to unavailability of an adequate mask. Currently the options for these groups of children are to ventilate invasively via a breathing tube (tracheostomy) which can lead to serious complications and costly care-packages or to abandon ventilation, eventually leading to respiratory failure and premature death. Persevering with an inadequately fitting mask leads to pressure sores, impairment of facial bone growth and significant disturbance to the sleep of the child and family due to noise from air leakage from the mask and alarms from the ventilator. These problems lead to an increased burden on nursing and hospital resources as well as harm and suffering to patients. The COMFORT study was funded by the NIHR in 2015 to develop novel mask-face interfaces to optimise mask fit to the needs of individual patients using 3D assessment and manufacturing technologies. Since then, we have developed a mask prototype and a modular headgear prototype that straps the mask onto the face. We have already demonstrated that our proposed method is more effective than a standard mass-produced mask/headgear in the laboratory setting with adult volunteers. In the first part of this project, we will carry out a proof-of-concept study to test the prototype mask/headgear system with children and young people that currently use NIV but have a poorly-fitting mask. We will compare our new system with their current mask by asking them to rate them in terms of comfort and fit as well as measuring the effectiveness of their ventilation. In the second part, we will work with Imperial University, who have developed software to automate and speed up the manufacturing process. We will scan 120 children to help develop the software to be suitable for children and then repeat the proof-of-concept study with a mask manufactured using the automated process. Following these studies we will apply for funding to carry out a multicentre UK-wide clinical trial.
NCT06655805
The aim of the here proposed study is to assess safety, performance and provide real world evidence (RWE) of the Hamilton Medical AG automated mechanical ventilation software packages in consecutive critically ill patients admitted to the intensive care unit.
NCT04524585
PNEUMA is a preliminary safety and feasibility trial of a novel approach to the titration of neuromuscular blockade (NMB) to safe spontaneous breathing in patients with moderate to severe acute hypoxemic respiratory failure (AHRF) supported with invasive mechanical ventilation.
NCT06008587
The hypothesis is that Nasal High Flow therapy for patients with Hypercapnic Acute Respiratory Failure without acidosis, in addition to standard treatment would improve the care.
NCT06675045
Recommendations from the European Respiratory Society are to use high-flow oxygen therapy rather than conventional oxygen therapy and non-invasive ventilation (NIV) in cases of acute hypoxaemic respiratory failure. Studies have shown that high-flow oxygen therapy can reduce the need for intubation and the initiation of NIV without reducing mortality. In addition, by improving oxygenation, high-flow oxygen therapy can create a feeling of security which may delay endotracheal intubation. Two studies have suggested that mortality is higher in patients receiving delayed intubation (≥ 48 hours) after failure of high flow oxygen therapy. Another study suggests that delayed endotracheal intubation after high-flow oxygen therapy ≥ 48 hours increases the risk of patient mortality independently of comorbidities and severity of illness on admission. Finally, other results suggest that the increased risk of mortality may be significant after 36 hours of high-flow oxygen therapy. It is therefore difficult to determine the right time for intubation and invasive ventilation. A diagnostic decision aid could be of great use to the attending physician in optimising the patient's respiratory assistance strategy, whether invasive or non-invasive. Consequently, any clinical marker that can provide early detection of altered respiratory status on high-flow oxygen therapy deserves to be evaluated. Respiratory variability is synonymous with respiratory 'good health'. A decrease in this same variabilitý is pathological and indicates an increase in the level of loads imposed on the respiratory system. It means that the measurement of respiratory variability indices may be one of these markers There are devices for non-invasive, continuous monitoring of respiratory variability, with automated frequency analysis of thoracic movement. In this study, respiratory variability indices will be measured in patients admitted to intensive care under high-flow oxygen therapy using an external sensor called REVAMODE.
NCT05085457
Patients on mechanical ventilation (MV) must undergo weaning, an interruption of ventilatory support. Several scores have been developed to predict this outcome, but the failure index in weaning and extubation remains high. The aim of this study is to evaluate the effect of ExPreS - Extubation Predictive Score - on the rate of successful extubation. This research will be conducted in a randomized clinical trial in ICUs of several hospitals. It is expected that there will be a difference between devices for predicting extubation success, and because ExPreS is a protocol that evaluates various parameters related to many organs and systems, it has a better ability to predict extubation success in MV patients.
NCT06442488
An observational study will be conducted in approximately 14 participants to evaluate the ability of a wearable, wireless acoustic Respiratory Monitoring System (RMS) to accurately measure a participant's respiratory rate, tidal volume, minute ventilation, and duration of apnea in a noisy environment. Sensor accuracy will be measured with adaptive filtering and active noise cancellation turned on versus turned off.
NCT06483984
The objective of this randomized cross-over trial is to assess the physiological effects of three different facemasks for noninvasive ventilation (Nivairo, Visairo, Optiniv) in patients with acute hypercapnic respiratory failure
NCT03431493
More and more people are surviving after receiving life support for respiratory failure in the intensive care unit, but these patients often experience problems with depression and physical functioning that lead to reduced quality of life. There is a lack of treatment for these patients, with past research suggesting that treatment may be more successful if mental and physical health are addressed at the same time. This research evaluates whether a therapy delivered via telephone and home visits, combining treatment for depression and physical rehabilitation, is feasible and might help patients recover.
NCT02939963
Patients who are intubated and mechanically ventilated for acute respiratory failure in the Intensive Care Unit (ICU) are at some point eligible for weaning. The common way to wean them from mechanical ventilation is to screen criteria for feasibility and, if present, to test feasibility by performing spontaneous breathing trial. This latter can be done either by setting a low pressure support level (expected to compensate the airflow resistance due to endotracheal tube) or by allowing the patient to breathe spontaneously through the tube without any support from the ventilator. Combination of low pressure assistance strategy (7 cm H2O) and positive expiratory pressure (PEP) of 4 cm H2O is the strategy used in our unit. Such a low pressure support level should actually result in a real assistance and, hence this is not the real spontaneous breathing capacity that is tested. Some ICU ventilators offer the option of compensating for the airflow resistance due to endotracheal tube, automatic tube compensation (ATC). Therefore, investigators aimed at comparing in patients ready to wean the usual procedure in our ICU and the ATC mode. In the ATC arm, the patients are breathing spontaneously through the endotracheal tube and are connected to the ventilator set at inspiratory pressure support of 0 cm H2O, PEP 4 cm H2O and ATC on. Two parallel arms depending on the order of allocation of each mode: pressure support 7 cm H2O + PEP 4 cm H2O then ATC or the opposite. The primary endpoint is the power of the work of breathing. The hypothesis is that the power of the work of breathing is greater in ATC than in the usual procedure, and hence this latter is a real ventilator support.
NCT06251375
Sedation remains a ubiquitous and crucial component of intensive care treatments in critically ill mechanically ventilated patients. Sedation relieves anxiety, reduces distress, and promotes tolerance of endotracheal intubation and associated life-sustaining interventions such as mechanical ventilation, cardiovascular assistance, and renal support. Thus, choosing the optimal sedative agent is vital to patient comfort, safety, and survival. Despite more than 20 years of intensive care sedation research, there is still no consensus on what constitutes best sedation practice. The Society of Critical Care Medicine, the premier critical care organisation in North America, published the 2018 Clinical Practice Guidelines on the management of Pain, Agitation/Sedation, Delirium, Immobility and Sleep (PADIS) disruption (chaired by our primary applicant W.A.) and issued weak recommendations to provide analgesia before sedation, to target light sedation whenever clinically feasible, and to use either dexmedetomidine or propofol over midazolam for the sedation of mechanically ventilated critically ill patients. Similarly, the American Thoracic Society produced a set of Clinical Practice Guidelines to promote liberation and weaning from mechanical ventilation in critically ill patients, with weak recommendations for the use of non-benzodiazepines as primary sedatives and to target light sedation when clinically possible. A weak recommendation was issued in an Intensive Care Medicine Rapid Practice Guideline published in 2022 to use dexmedetomidine over propofol for sedation of critically ill adults, if the desired outcome is a reduction in delirium. These guidelines, however, do not consider age-dependent pharmacokinetics and pharmacodynamics, illness severity, timing of sedative administration, operative vs medical reason for admission, or the changing dynamics of sedation practice at different phases of critical illness. The lack of high-level evidence to inform sedation practice in the critically ill has led to approaches that are mainly opinion-based and lack the support of evidence from large multicentre, international randomised clinical trials.
NCT07120438
The goal of this observational study is to evaluate the predictive value of diaphragmatic ultrasound compared to the Rapid Shallow Breathing Index (RSBI) in determining weaning success among mechanically ventilated patients in the ICU for more than 48 hours. The main question it aims to answer is: Which is more effective in predicting weaning success: diaphragmatic ultrasound (including Diaphragmatic Excursion \[DE\] and Diaphragm Thickening Fraction \[DTF\]) or RSBI, in patients ventilated \>48 hours in the ICU of Dr. Sardjito General Hospital, Yogyakarta? Participants will be adult ICU patients who are undergoing weaning from mechanical ventilation after more than 48 hours. Before extubation, each participant will undergo diaphragmatic ultrasound assessment to measure DE and DTF, along with RSBI measurement. The predictive accuracy of these parameters will be evaluated by comparing them with the actual weaning outcomes. Secondary objectives include: 1. Assessing whether diaphragmatic ultrasound is associated with a higher weaning success rate than RSBI. 2. Evaluating the correlation between DE values and successful weaning. 3. Determining the optimal cutoff values of DE and DTF as predictors of weaning failure. 4. Analyzing the incidence of weaning failure in patients who do not meet optimal diaphragm function criteria. 5. Identifying DE and DTF thresholds that may help reduce the risk of reintubation.
NCT06102330
This is a multicenter study to test a decision-making support process for families and clinicians facing decisions about chronic home ventilation for a child. The investigators hypothesize that the intervention will increase family preparedness for decision-making and will improve clinician-family shared-decision making. Half of families will be assigned to "usual care" arm and half to the "intervention" arm. Intervention families will view the study website with study staff and will answer questions related to website content. All families will be interviewed and surveyed at 1, 6 and 12 months after enrollment. Each family will designate 1-2 physician involved in the decision about home ventilation; each physician will be interviewed and surveyed at 1 month.