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NCT06495021
This study is to see Osteopathic Manipulative Therapy, or OMT, can aid in treating patients being seen for respiratory illness and associated symptoms. The hypothesis is that the addition of OMT therapy, alongside other standard care (such as a medication), can help lessen patient symptoms sooner than just other treatment alone, and the duration of the condition will shorten as well.
NCT04326114
A randomized controlled clinical trial will be carried out using inspiratory and expiratory training devices on healthy subjects recruited in social networks and university environments. The aim will be to determine the effectiveness and safety in the prevention and severity of COVID-19 disease by a respiratory training with inspiratory and expiratory devices.
NCT04649736
Some COVID-19 survivors may have respiratory and mental health sequelae, especially those who required hospitalization. The investigators hypothesize that the participation of a rehabilitation program composite by home-based respiratory physiotherapy and telephone-based psychological support will improve respiratory function, quality of life, and psychological status in severe COVID-19 patients.
NCT06921278
The goal of this study is to develop a brief Drug and Alcohol Respiratory Health Test (DARHT) and offer it for routine use in clinical assessment and medical reviews
NCT03230968
Background. Mexico is lacking guidelines that provide an integral approach for the prevention and control of respiratory diseases in adults. The World Health Organization (WHO) proposed a "Practical Approach to Lung Health" (PAL) using generic guidelines to be used in primary health care settings for diagnosis and treatment of respiratory diseases. These guidelines were adapted to the Mexican context as AIRE campaign by the Instituto Nacional de Enfermedades Respiratorias, Mexico. Objective. To evaluate the feasibility and effectiveness of implementing a model of care for respiratory diseases in adults based on AIRE guidelines,. Materials and methods. Prospective quasi-experimental pre-post study. During 03-08/2013 (phase 1), investigators recruited consenting subjects older than 15 years of age seeking medical care in primary care centers in Orizaba, Veracruz. Researchers investigated sociodemographic, epidemiological and clinical information before consultation. On patients who had been diagnosed with respiratory disease by a physician, researchers investigated prescribed treatment on leaving the physician´s office. A month later conducted a home visit to investigate clinical outcome. During 09/2014 we trained doctors from the participating health centers in "AIRE" guidelines. From 10/2014 to 03/2015 (phase 2) researchers again surveyed all consenting subjects older than 15 years of age who received health services in the same health centers following the same procedures as in phase 1.
NCT03238209
To evaluate the compatibility and correlation between noninvasive surface respiratory electromyography and invasive transesophageal diaphragmatic electromyography measurements, as facilitating indicators of neural respiratory drive evaluation during treadmill exercise. Transesophageal diaphragmatic EMG (EMGdi,es) and surface inspiratory EMG, including surface diaphragmatic EMG (EMGdi,sur), surface parasternal intercostal muscle EMG (EMGpara) and surface sternocleidomastoid EMG (EMGsc) were detected simultaneously during increasing capacity exercise in stable patients with COPD. EMGdi,es, EMGdi,sur, EMGpara and EMGsc was quantified using root mean square (RMS), which represent as RMSdi,es, RMSdi,sur, RMSpara and RMSsc.
NCT04681430
This study is a 4-arm, multicenter, randomized, partly double- blind, controlled trial to evaluate the safety and efficacy of convalescent serum (CP) or camostat mesylate with control or placebo in adult patients diagnosed with SARS-CoV-2 and high risk for moderate/severe COVID-19. The working hypothesis to be tested in the RES-Q-HR study is that the early use of convalescent plasma (CP) or camostat mesylate (Foipan®) reduces the likelihood of disease progression to modified WHO stages 4b-8 in SARS-CoV-2 positive adult patients at high risk of moderate or severe COVID-19 progression. The primary endpoint of the study is the cumulative number of individuals who progressed to or beyond category 4b on the modified WHO (World Health Organization) COVID-19 ordinal scale within 28 days after randomization.
NCT05881590
Pulmonary rehabilitation is an exercise and education programme that helps improve breathlessness and quality of life for people living with lung and breathing problems. It improves exercise levels and breathlessness and is a recommended treatment for people with lung diseases and symptoms. Standard pulmonary rehabilitation programmes involve individuals attending group classes at hospitals or community centres, twice a week for 8 weeks. These classes are supervised by physiotherapists. At the moment, there are long waiting times for pulmonary rehabilitation in the NHS. Some patients may prefer more pulmonary rehabilitation based in their own home. This might be because they find it difficult to travel to classes. Some would like to do more home pulmonary rehabilitation in between supervised classes or continue pulmonary rehabilitation after the 8-week supervised programme. The blending between supervised classes and home pulmonary rehabilitation is known as HYBRID PULMONARY REHABILITATION. Hybrid pulmonary rehabilitation is not being provided routinely in the NHS, but the NHS would like to see it used more as it might help reduce waiting times and give patients more choice on how to access pulmonary rehabilitation. The study will assess the feasibility of a larger study to provide strong evidence on patients' uptake and adherence to the hybrid programme, and the impact on patients' health outcomes and service delivery. The investigators will also look at what measures would be best to use in a larger study. The study will recruit up to 100 patients. These individuals will be aged 18 years or older, have respiratory disease and a referral for pulmonary rehabilitation. Individuals with reasons why they cannot exercise will be excluded. Participants will be provided with an application (App) that can be installed on a mobile phone. This App is called Active+me REMOTE and is made by a company called Aseptika Ltd (www.activ8rlives.com). Active+me REMOTE provides live online, video exercise classes; pre-recorded exercise classes; a walking programme; educational talks; and a care plan personalised for the user. Data will be collected at the beginning and end of the hybrid pulmonary rehabilitation programme and will include routinely collected data as part of usual care. Additional data will be collected via the App and trial surveys. The investigators will ask staff and patients about the experiences of the new way of delivering rehabilitation and explore how cost effective it is.
NCT06470932
This study aims to assess the quality of life of patients six months after admission to a pediatric intensive care unit for acute respiratory failure. Children's quality of life will be assessed using the PedsQL scale at 6 months. This is a prospective cohort diagnostic and prognostic study.
NCT04693091
The aim of this study is to explore the acceptability and feasibility of a novel medical device system for remote monitoring of breath and heart sounds (replicating remotely, and in an easy-to-use garment, that which a clinician would do with their stethoscope to listen to a patient's chest, by evaluating sounds captured through a wearable device (Senti)). As a first-in-man study, the investigators will investigate the safety of the Senti device, the usability and acceptability of the device; and ensure technical and practical feasibility of the device in a real-world clinical setting. 10 patients will be recruited (the study participants) in two tranches (6 and 4) who are being discharged from A\&E into the care of the community respiratory team. These patients will wear the Senti device. The first tranche will use the device over a single session lasting 20 minutes only. The second tranche (which will include patients from tranche one, and which will only proceed if no adverse events are detected in tranche one), participants will wear the device at their discretion (particularly encouraged to wear overnight) over the course of 5 days. The investigators will survey the study participants to answer three key questions: 1. What is the feasibility of the Senti data-capture device? 2. Is this device usable in clinical practice? 3. What are the requirements to train patients to use the device? The investigators will also consider: 4. Does the device function technically and practically, in real-world clinical scenarios? 5. What are the key expected and unexpected safety issues related to using the device (with a particular emphasis on whether the device is likely to cause pressure sores). These questions will establish the feasibility of using the Senti data capture device as part of a novel medical device system for the autonomous evaluation and monitoring of bioacoustic signals.
NCT06726226
This study examines the respiratory outcomes of preterm infants born at gestational ages less than 29 weeks, spanning from birth to 24 months corrected age. It delves into the intricacies of respiratory function impairment attributable to diverse factors, such as respiratory distress syndrome, bronchopulmonary dysplasia, postnatal corticosteroids, ventilatory support, as well as nutritional aspect during NICU stay. Furthermore, it scrutinizes the incidence of chronic respiratory diseases stemming from these conditions, assessing their long-term impact on respiratory prognosis post-discharge. In addition to respiratory aspects, the research extends its focus to the growth and developmental outcomes of preterm infants. By synthesizing these multifaceted elements, the study aspires to enhance current treatments and preventative measures for respiratory conditions in preterm infants.
NCT00192439
\- Estimate the incidence rate of hMPV infection detected by RT-PCR from frozen nasal wash aspirates in children at high risk for severe LRI disease (hospitalized at \<2 years of age).
NCT03119727
Evaluation of automatic titration of oxygen with a new version of FreeO2 (V4)
NCT04566523
It is widely described in the literature that exercise training improves patients' exercise tolerance, quality of life, symptoms, anxiety and depression, regardless of the location. Despite overwhelming evidence of the benefits of exercise training, only a very small percentage of eligible people have ever completed a program. Alternative modes of exercise training are needed to improve equity of access for patients with chronic respiratory disease. So TeleRehabilitation, using information and communication technologies to provide distance exercise training services, may be an answer.
NCT07047768
Health Data Warehouses (HDWs) are a major resource for the development of artificial intelligence (AI) applied to predictive and personalized medicine. We propose a project leveraging the HDW of the Hospices Civils de Lyon (HCL) to study acute lower respiratory tract infections (ALRTIs), a major public health issue due to their impact on morbidity, mortality, and healthcare costs. The COVID-19 pandemic has further highlighted their burden and complexity. ALRTIs can be caused by viral agents (e.g., influenza, RSV, SARS-CoV-2) or bacterial pathogens (e.g., pneumococcus, mycoplasma, legionella), and may be acquired in the community or during hospitalization. Given their frequency and potential severity, early identification of patients at risk of clinical deterioration is crucial, especially those likely to require intensive care. The recent deployment of the HCL HDW now allows for the structured extraction, linkage, and storage of administrative, clinical, biological, and pharmaceutical data. This system supports the reconstruction of each patient's care trajectory and clinical history, offering new opportunities for advanced modeling. In recent years, several predictive tools have been developed to estimate the severity or prognosis of respiratory infections, including PSI/FINE, qSOFA, CURB-65, the EPIC sepsis model, and early warning systems (EWS). The COVID-19 crisis spurred the creation of new scores and models to predict clinical outcomes or mortality, as well as online tools and apps for clinicians. However, many of these tools rely on limited datasets (often single-center or small cohorts), static variables (e.g., comorbidities), and do not consider the temporal dynamics of patient data. Some research teams have explored the use of multicenter data and machine learning (e.g., MLHO-Machine Learning to predict Health Outcomes), notably to model COVID-19 outcomes. Nonetheless, most models lack integration of longitudinal clinical and biological data, and few are generalizable to all respiratory infections. Additionally, existing tools rarely account for real-time contextual variables such as current levels of population immunity or vaccine availability. Our project aims to develop a dynamic AI-based detection algorithm to predict the risk of ICU admission in patients with ALRTIs. The model will be trained on retrospective HDW data from the HCL, including the evolution of vital signs, laboratory values, treatments, and demographic factors. By capturing temporal trends and clinical trajectories, our algorithm will go beyond static scoring systems and offer real-time risk stratification. Ultimately, this algorithm could be embedded in hospital information systems as a clinical decision support tool. By generating alerts for early signs of deterioration, it would enable more timely interventions, resource optimization, and improved patient outcomes. This approach differs from existing models in two fundamental ways. First, it covers a broad patient population with viral and bacterial pneumonia of both community and hospital origin. Second, it explicitly incorporates the longitudinal dimension of health data, allowing the model to learn from dynamic changes in patient condition. This temporal perspective is key to improving prediction accuracy and enabling early detection of deterioration.
NCT06716502
Acute respiratory failure is a medical emergency rapidly leading to death, if not timely treated. Prompt Continuous Positive Airway Pressure (CPAP) improves patient outcomes. However, pre-hospital CPAP is currently limited to healthcare providers due to the absence of easy-to-use and immediate devices specifically designed for the non-medical population. The efficacy and usability of a new portable CPAP device will be assessed. This device is specifically designed for potential use in out-of-hospital scenarios involving acute respiratory failure. The evaluation will focus not only on the performance of the device but also on its easiness of use.
NCT04896866
COVID-19 is respiratory disease caused by the severe acute respiratory coronavirus 2 (SARS-CoV-2), a novel coronavirus which has spread rapidly across the world with over 149.9 million laboratory confirmed cases and over 3.1 million reported deaths since December 2019. Approximately 4-8% of hospitalized patients with COVID-19 have co-infection with bacterial pathogens however there is widespread and often broad-spectrum antibiotic use in these patients. This is a prospective, multi-center, non-inferiority pragmatic clinical trial of antimicrobial stewardship prospective audit and feedback versus no antimicrobial stewardship intervention on physicians attending to patients with proven SARS-CoV-2 infection confirmed by nucleic acid testing in the preceding 2 weeks of hospitalization for acute COVID-19 pneumonia. Prospective audit and feedback is the real time review of antibacterial prescriptions and immediate feedback to prescribers to optimize antimicrobial prescriptions. Hospital beds will be stratified by COVID unit and critical care unit beds, and will be computer randomized in a 1:1 fashion into 2 arms (antimicrobial stewardship intervention versus no antimicrobial stewardship intervention) prior to study commencement at the participating site. Patients hospitalized to study-eligible beds will be followed for primary and secondary outcomes. The objective of this study is to determine the effect of an antimicrobial stewardship intervention (prospective audit and feedback) on clinical outcomes in patients hospitalized with acute COVID-19.
NCT06310629
Based on early bench-testing data and subsequent clinical case studies in the U.S., "Intrinseque Health" non-rebreathing mask (IHNRM) has delivered virtual elimination of air entrainment and preferential delivery of all available oxygen first into the alveolar spaces by sequential opening of valves in its controller manifold, even at oxygen flow as low as 10 LPM, patient can attain high alveolar oxygen concentration of 75% or more-far higher than attainable with face mask or nasal cannula. Numerous intubated patients emerging from the operating room require intensive critical care specialist supervision in order to transition to the regular care. This would enable higher patient turnover and more efficient utilization of hospital resources, if patient can be transited to the regular care earlier by using a device that supports high oxygenation. This will enable a faster, safe and smooth extubation in critical care, and earlier discharge from intensive care ward. This study is anticipated to take only around 2.5 hour per patient to complete. Patients meeting the inclusion and exclusion criteria of this study are placed on IHNRM and monitored until steady state of SpO2 of 95% or higher on 7-10 LPM has been maintained for at least 2 hours, when they can be discharged from the post-anesthesia care unit (PACU) to the regular care ward. The study is the parallel design study. 60 patients will be randomly selected to use the IHNRM, and 30 subjects will be placed on HFNC. Blood oxygen concentration (SpO2), respiratory rate, end tidal CO2 concentration (EtCO2), and vital sign will be recorded in the study. The endpoint of the study is to compare the effect after using between "IHNRM" and HFNC.
NCT06148194
Acute respiratory infections are common diseases worldwide with the highest incidence and mortality rates, especially among children. Currently, the prevention of acute respiratory infections in children still faces certain limitations. Although there is a vaccine available for influenza, there are no vaccines yet for RSV and adenovirus in children, and influenza vaccination needs to be repeated annually to achieve optimal effectiveness. Therefore, maintaining respiratory and throat hygiene is essential for both treatment and prevention, ensuring respiratory health for children and reducing the risk of bacterial co-infections. In recent years, preventive strategies for respiratory inflammation have garnered increasing attention, with probiotics being shown to have the potential to support treatment and prevention \& reduce the risk of recurrent respiratory infections, thus decreasing reliance on antibiotics. Here, the investigators propose that direct nasal spraying of probiotics may be safe and effective in preventing respiratory diseases. The aim of the study is to evaluate the effectiveness of two types of nasal- praying Bacillus probiotics including LiveSpo Navax (1 billion/mL x 30 mL B. subtilis and B. clausii) and LiveSpo Navax Kid (0.6 billion/mL x 30 mL B. subtilis and B. clausii) in preventing respiratory diseases. Study Population: The sample size is 600. Description of Sites: The study is conducted at preschools in Son Tay Province, Hanoi, Vietnam. Description of Study Intervention: A total of 600 eligible children are randomly divided into three groups (n = 200/group each). Children in the Control group received 0.9% NaCl physiological saline twice daily (morning and afternoon), with 2 sprays in each nostril and 2 sprays in the throat each time (totally 6 sprays each time), continuously for four weeks. Children in the Probiotic 1 group receive LiveSpo Navax product, and children in the Probiotic 2 group receive LiveSpo Navax Kid, with the same dosage and frequency as the Control group. Study Duration: 12 months.
NCT03704935
Chronic respiratory diseases are characterized by a progressive and long term deline. Pulmonary rehabilitation (exercise training and therapeutic education) can improve several disease outcomes like dyspnea, exercise tolerance and health-related quality of life. After an inpatient PR program, maintenance program can stabilize the disease outcomes. However, maintenance program are heterogeneous and long term benefits (\>36 month) have been observed in only one study, which is not feasible in France. A realistic maintenance program as proposed by the French Air+R network (http://airplusr.com/wordpress/) has only demonstrated benefits after 12 month. In addition, the time course of patients may be heterogeneous, with differens clusters that could be influenced by the clinical, functional and systemic determinants. In particular, the cellular muscle microenvironment could be deleterious for the muscle function in patients, caused by a "spill-over" of inflammatory pulmonary molecules in the systemic milieu.