Clinical Research Directory

REspiratory reHABilitation and PSYchiatric Comorbidities

Patients with respiratory insufficiency, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, asthma, bronchiectasis, and, to a lesser extent, other pathologies that result in respiratory insufficiency and require rehabilitation are admitted to in-hospital Respiratory Rehabilitation. Several studies have assessed the impact of comorbidities in the most frequent respiratory diseases such as COPD, asthma, pulmonary fibrosis, and cystic fibrosis in terms of worsening mortality, morbidity, and disease progression. However, to our knowledge, there is no reliable quantification in Italy of the percentage of the presence of mental disorders (psychiatric/neurodegenerative) according to the Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-5 classification in respiratory patients as well as the prevalence of mental disorders present among patients requiring in-hospital rehabilitation programs. The study hypothesizes that these disorders are present among patients admitted to rehabilitation centers and that they may impact the final rehabilitation outcome.

REVIVe: Frailty, Rehabilitation, and Outcomes in Critically Ill Adult and Pediatric Survivors of COVID-19 or ARI

Background: Many adults and some children with COVID-19 or acute respiratory infection become critically ill and need advanced life support in the Intensive Care Unit (ICU). Frailty is a medical condition of reduced function and health. Adults with frailty have a lower chance of surviving critical illness. The investigators are still learning about critically ill adults with COVID-19 or acute respiratory infection, and do not have much information on how frailty affects outcomes in critically ill children, with or without COVID-19 or acute respiratory infection. Rehabilitation can help survivors of COVID-19 or acute respiratory infection by improving strength and improve quality of life (QOL). Objectives: The main goal of this research study is to see if patients with frailty have a lower chance of surviving COVID-19 or acute respiratory infection critical illness and more health problems after survival than patients without frailty. The investigators will also study the types of rehabilitation received by patients with COVID-19 or acute respiratory infection. Methods: The investigators will include adults and children with COVID-19 or acute respiratory infection who are admitted to the ICUs that participate in the study. The investigators will gather data about each patient, including before and during their illness. Outcomes: The investigators will collect level of frailty, function, and types of therapy, or rehabilitation received by patients. In adults, the investigators are most interested in learning if frailty influences mortality, or death. In children, the investigators are most interested in whether children with COVID-19 or acute respiratory infection critical illness are more likely to develop frailty. The investigators will also study post-hospital discharge location in survivors (e.g., home, rehabilitation). Relevance: The COVID-19 pandemic is a global public health crisis. It is critical to understand how COVID-19 and other acute respiratory infection critical illness affects groups of people who are at higher risk, and the impact on outcomes that are important to patients, like functioning and QOL. The results will help policy makers plan post-hospital services for survivors, help healthcare workers understand the importance of rehabilitation practice for patients with COVID-19 or acute respiratory infection, and help researchers develop treatments to improve QOL after COVID-19 or acute respiratory infection.

Procedural Skills Transfer in Bronchoscopy

Brief summary The goal of this Feasibility study is to capture bronchoscopy data from patients (Group1) and bronchoscopists (Group 2) over a period of three years. The investigators wish to collect the pre-procedure CT scans and endoscopy videos of 300 patients. Up to 20 bronchoscopists will take part in the study Primary outcomes 1. To collect imaging data from patients undergoing routine bronchoscopy procedures 2. To collect movement data from clinicians performing the routine bronchoscopy procedures using a sensory Glove Secondary outcomes 1. Integrate the data gathered with procedure guidelines to develop a representation of procedure success using machine learning algorithms. 2. Develop an actionable knowledge base for bronchoscopy skill transfer to novice/untrained medical staff. 3. Investigate the feasibility of developing models of bronchoscopy procedures to develop training tools in the future There are no additional samples or time commitments from the participants in Group 1. The participants in Group 2 will be asked to answer a short questionnaire about their experience in performing bronchoscopies and will be asked to wear a sensory glove during the bronchoscopy procedure to capture their hand movements.

How OMT Benefits Newly Diagnosed Patients With Respiratory Illness When Given Alongside Other Standard Care.

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.

Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit

Premature infants are susceptible to complications related to infrequent and non-standardized oral care. Although the benefits of frequent standardized oral care are known to reduce oral dysbiosis (increased level of potentially pathogenic bacteria) and its associated complications in critically ill adults leading to established evidence-based guidelines, no such information exists for VLBW infants. The proposed study will prospectively follow 168 VLBW infants for 4 weeks following birth.

Partners in Children's Health (CSN): A Randomized Trial of an Attachment Based Intervention

The goal of this randomized controlled trial is to evaluate the impacts of an attachment-based intervention (Attachment Biobehavioral Catch-Up (ABC) and Home Book-of-the-Week (HBOW) program on emerging health outcomes (i.e., common childhood illnesses, body mass index, and sleep) in low-income Latino children (N=260; 9 months at enrollment). It is hypothesized that children randomized to ABC will have better health outcomes in comparison to the HBOW control group.

Prospective Multicenter Screening for Thoracic Disease Via Radiography

This multicenter, prospective study aims to evaluate the real-world clinical utility of chest X-ray (CXR) for large-scale thoracic disease screening. Adult participants presenting for health examinations will undergo digital CXR screening, and any suspected abnormalities will be confirmed via a gold standard reference, such as a chest CT scan or clinical follow-up. The primary outcome measure is the detection rate (screening yield) of confirmed thoracic conditions. Secondary measures will assess diagnostic accuracy (sensitivity and specificity), false-positive rates, and multi-center reading consistency. By providing prospective, large-cohort evidence, this research seeks to validate the cost-effectiveness and feasibility of CXR in identifying early-stage lung, pleural, and cardiac abnormalities, ultimately guiding public health strategies and optimizing early medical intervention.

A New Portable Device for Non-invasive Ventilatory Support

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.

Cognitive Muscular Therapy for Patients With Long-COVID and Breathing Pattern Disorder

The aim of the study is to test a treatment known as "Cognitive Muscular Therapy (CMT)" for reducing breathlessness and improving autonomic function in patients with long-COVID.

AMPLE-3: IPC Plus Talc vs VATS in Management of Malignant Pleural Effusion

The purpose of this study is to determine if an indwelling catheter is more effective than surgical pleurodosis in treating malignant pleural effusion. Who is it for? You may be eligible for this study if you are an adult who is suffering from symptomatic proven pleural malignancy or an otherwise unexplained pleural effusion. Study details Consenting participants will be randomised to one of two treatment arms: * Arm 1: Indwelling pleural catheter. A long term catheter is inserted under the skin in order to allow ongoing drainage of the pleural fluid. Participants will then be instructed to undergo a daily drainage regimen for 14 days at home. * Arm 2: Surgical pleurodesis. Participants under a key-hole surgery to remove fluid and facilitate lung re-expansion. Participants will then be followed up at discharge, 14 days, monthly for 6 months and then every 3 months up to one year post-procedure. These visits will include completion of Quality of Life questionnaires, a chest xray, an ultrasound (if thought necessary) and if you are at the lead site (Sir Charles Gairdner Hospital) a review of your Actigraphy logs up to 6 months after discharge. It is hoped this research will help to provide effective symptom control with minimal intervention for those with malignant pleural effusion.

Post COVID-19 REspiratory Mechanisms and the Efficacy of a Breathing Exercise Intervention for DYsregulated Breathing

A pilot Study To investigate the efficacy of a breathing intervention for improving persistent breathlessness due to dysregulated breathing following COVID-19 when compared to usual care.

The Study of the Use of Nintedanib in Slowing Lung Disease in Patients With Fibrotic or Non-Fibrotic Interstitial Lung Disease Related to COVID-19

This is a collaborative study between Icahn School of Medicine at Mount Sinai, Boehringer Ingelheim Pharmaceuticals and up to 9 other clinical centers across the US to determine the effect of nintedanib on slowing the rate of lung disease in patients who have been diagnosed with COVID-19, and have ongoing lung injury more than 30 days out from their diagnosis. Required one of the following after diagnosis with SARS-CoV-2: supplemental oxygen by nasal cannula, high flow oxygen, non invasive ventilation such as CPAP or BIPAP, or mechanical ventilation or a history of desaturation below 90%.

Children's Health in London and Luton (CHILL)

Investigating the impact of London's Ultra Low Emission Zone on children's respiratory health

Comparing 6-Minute Walk Tests for Ambulatory Oxygen Assessment

Patients with lung disease who report breathlessness on exertion are often referred for a 6MWT. Due to the nature of the 6MWT (hereon referred to as a Max-6MWT), patients are required to walk as far as they can in 6 minutes. This may lead to an inaccurate assessment of their requirement for ambulatory oxygen as this form of exercise may not correspond to their normal daily activities. In this study, patients who are routinely referred for a Max-6MWT to investigate possible exercise-induced hypoxaemia will be invited to perform an additional walking test which is performed at their normal walking speed, referred here on in as a Nor\_6MWT. We hypothesise that performing a Nor\_6MWT will provide a more accurate assessment of a patients' oxygen requirement, primarily from their oxygen desaturation during the test.

Optimization of Exhaled Biomarker Collection and Analysis

This is an exploratory study designed to optimize, standardize, and validate novel breath biomarkers; there are no objective endpoints. The goal of this study is to generate pilot data to be used to generate hypothesis-driven studies.

Non-invasive Assessment of Inspiratory Effort and Tidal Distension During Non-invasive Ventilation (INSPIRE)

The goal of this observational study is to evaluate whether the airway occlusion pressure recorded during a sudden end-expiratory breath-hold (ΔPocc) is correlated with esophageal swing in pressure and the reliability of P0.1, driving pressure, plateau pressure, pressure-muscle index, and diaphragm ultrasound as noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV. The main questions this trial aims to answer are: \- Primary Outcome: whether the airway occlusion pressure recorded during a sudden end-expiratory breath-hold (ΔPocc) is correlated with esophageal swing in pressure and the reliability of various noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV. Secondary outcomes will include: * Statistic metric of association between P0.1, ΔP, PMI and ΔPes * Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and PaO2/FiO2 ratio * Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and tidal volume * Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and DTF% * Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and Ex/DTF% * Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and respiratory rate, VAS dyspnea and VAS discomfort. Participants will undergo the following tasks and treatments: * Complete written informed consent before enrollment. * Post-extubation noninvasive ventilation via nose-to-mouth and full-face masks. * Monitoring of esophageal pressure (in all patients the catheter will be placed before extubation, according to clinical judgment, and its correct position will be verified through a positive pressure occlusion test) * Continuous recording of airway pressure, flow, and esophageal pressure (Pes), using a dedicated pneumotachograph and pressure transducer. * Sudden end-inspiratory and end-expiratory occlusion maneuvers, to measure plateau pressure (Pplat) and end-expiratory airway occlusion pressure (ΔPocc), respectively. * Collection of hemodynamic and arterial blood-gas parameters, performed according to clinical judgment, along with assessments of dyspnea and discomfort using a modified visual analogue scale (VAS). * Diaphragm ultrasound during occlusion maneuvers, measuring diaphragm displacement, diaphragm thickening fraction (DTF%), and diaphragmatic excursion (Ex) under various conditions.

Symptoms, Respiratory Dysfunction and Frailty Level in Allergic and Eosonophilic Asthmatics

The aim of this study is to determine the level of respiratory dysfunction, symptoms and frailty in patients with asthma according to different endophenotypes (allergic and eosonophilic asthma). In the light of the data obtained, it is thought that rehabilitation approaches that can be determined according to different endophenotypes in line with the evaluated parameters will guide health professionals working in this field. Hypotheses H0: There is no difference between allergic and eosonophilic asthmatics in terms of pulmonary function, respiratory dysfunction, symptoms, dyspnoea, fatigue, rhinitis, perception of breathlessness in activities of daily living, asthma control, level of frailty or quality of life. H1: There is a difference between individuals with allergic and eosonophilic asthma in terms of pulmonary function, respiratory dysfunction, symptoms, dyspnoea, fatigue, rhinitis, perception of breathlessness in activities of daily living, asthma control, level of frailty or quality of life.

Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress

Use of caffeine citrate in late-preterm infants with respiratory distress is questionable. Oliphant and colleagues found in a recently published study that caffeine therapy use in late-preterm infants at a loading dose of 20 and 40 mg/kg and maintenance dose of 10 and 20 mg/kg/day reduces the incidence of intermittent hypoxia events by 61 and 67% respectively. The investigators hypothesized that caffeine will improve respiratory drive, prevent apnea, shorten the hospital stay and improve arousal state in late preterm infants. The investigators aim to study the effect of caffeine citrate on late preterm babies as regard duration of respiratory support, duration of hospital stay, respiratory morbidity, incidence and frequency of apnea.

Prospective Observational Study to Characterize Patients Treated at Internal Medicine Clinics

Patients referred to internal medicine wards are becoming increasingly complex and fragile. Despite deep knowledge of their specific disorders, steps are required to improve overall management of their acute and chronic conditions. The main objective of the study is to identify demographic, clinical, laboratory and radiological markers of disease severity and activity in patients with diseases treated at general medicine wards (respiratory disease, immune-mediated disease, sepsis, metabolic disease, rare disease, frailty, pregnancy pathology) in order to improve their diagnosis, monitoring and treatment processes.

The Effect of Vitamin E Supplementation on Hospital Stay Duration in Non-cyanotic Heart Disease Children With Lower Respiratory Tract Infections

Congenital heart disease can lead to serious health issues, particularly an increased risk of infections, specifically respiratory infections. Lower respiratory tract infections are the fifth leading cause of death globally. Also considered a significant cause of morbidity and mortality among children with congenital heart disease. In Egypt, it is estimated that 10% of deaths in children under the age of 5 years are probably caused by lower respiratory tract infections and other acute respiratory infections. common non-cyanotic CHD like Ventricular septal defect predispose to bronchopneumonia. Hemodynamically significant congenital heart disease with pulmonary congestion increases the risk of lower respiratory tract infections and hospitalizations. This relies on several modifiable risk factors, including low socioeconomic status, poor diet, overcrowding, prematurity, male gender, and exposure to secondhand smoke. Micronutrients play a crucial role in strengthening the immune system. Many Studies have shown that when children are supplemented with various micronutrients, they experience fewer episodes of acute respiratory infections, and the duration and severity of these infections are reduced. Vitamin E is essential for immune system function and may lower disease risk by enhancing immune responses. It protects neurons and respiratory mucosa from oxidative damage and has been linked to a reduced incidence of asthma and inflammation, potentially safeguarding young children from atopy and wheezing. There are no available studies in our locality about the effect of vitamin E supplementation on the length of hospital stay for non-cyanotic cardiac patients with lower respiratory tract infections.

Development of the Drug and Alcohol Respiratory Health Test

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

The State of Nebulizer Therapy in Russian Federation

It is known that the inhalation (nebulizer) use of drugs is of great importance in the intensive care of patients with acute and chronic respiratory failure of various origins. Searching PubMed data for the last 5 years (2017-2022) for the keywords "nebulizer therapy" revealed 533 publications, and "mesh nebulizer therapy" - only 25 sources. During the same period, the national database (E-Library) has 75 publications for the keywords "nebulizer therapy", and 4 sources for "mesh nebulizer therapy". It should be noted that almost all publications are devoted to the use of nebulizers for specific diseases and pathological syndromes. There are no works evaluating the adherence of specialists, systemic indications and actually used methods. The aim of trial is to study the current state of the use of nebulizer therapy in medical organizations and identify ways to improve its effectiveness This study is planned to be carried out using a questionnaire using a database based on the Internet electronic survey form.

Validation of an Artificial Intelligence Enabled Diagnostic Support Software (ArtiQ.Spiro) in Primary Care Spirometry Datasets - a Retrospective Analysis

A retrospective study to evaluate the diagnostic performance of an Artificial Intelligence enabled software (ArtiQ.Spiro) in UK primary care spirometry datasets.

Extremely Preterm Respiratory Outcome Cohort

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.