Clinical Research Directory

Respiratory Physiotherapy and PMR After Cardiac Surgery

This study aims to evaluate the effects of respiratory physiotherapy combined with progressive muscle relaxation exercises on dyspnea, anxiety, hemodynamic status, and delirium symptoms in patients after cardiac surgery. This randomized controlled trial will include 116 patients who will be randomly assigned to an intervention group or a control group. The intervention group will receive respiratory physiotherapy and progressive muscle relaxation exercises in addition to routine postoperative care for 30 minutes per day over eleven days, while the control group will receive routine care only. Outcome measures will include dyspnea assessed by the Modified Borg Scale, anxiety assessed by the State-Trait Anxiety Inventory, hemodynamic parameters obtained from vital signs, and delirium symptoms assessed using the Nursing Delirium Screening Scale. It is hypothesized that the combined intervention will reduce dyspnea and anxiety levels, improve hemodynamic stability, and decrease delirium symptoms. The findings are expected to contribute to improved postoperative recovery and reduced complication risks following cardiac surgery.

Visual and Auditory Stimulation in Intensive Care Patients

This study is a randomized controlled experimental clinical trial designed to investigate the effects of visual and auditory stimulation on dyspnea severity, sleep quality, and anxiety levels in patients receiving noninvasive mechanical ventilation (NIMV) support in a secondary-level cardiac intensive care unit. A total of 44 patients (22 in the intervention group, 22 in the control group) are planned to be included in the study. Patients in the intervention group will be exposed to images of the Northern Lights projected onto the ceiling and white noise simultaneously for 30 minutes each night over two nights. The control group will receive no intervention other than routine nursing care. Data will be collected using the Dyspnea-12 Scale, the State Anxiety Inventory, the Richards-Campbell Sleep Scale, and a physiological parameters form. The study results are expected to contribute to evidence-based practices aimed at reducing dyspnea and anxiety, improving sleep quality, and enhancing patient comfort in intensive care patients through non-pharmacological methods.

The Effects of Wintergreen Essential Oil Inhalation on Alleviating Dyspnea Among Patients With Pneumonia

Pneumonia is a major public health concern globally and domestically. Dyspnea experienced by hospitalized pneumonia patients often induces anxiety and psychological distress. Wintergreen essential oil, primarily composed of methyl salicylate, is commonly used for comfort care and respiratory relief. This study aims to evaluate the effects of wintergreen essential oil inhalation on dyspnea, physiological parameters, laboratory data, pulmonary function, and subjective comfort in hospitalized pneumonia patients.

Multi-site Trial of a Brief Behavioral Intervention for Dyspnea in Patients With Advanced Lung Cancer

Dyspnea, or breathlessness, is one of the most common and distressing symptoms experienced by patients with advanced lung cancer. The purpose of this multi-site trial is to test the effectiveness of a dyspnea intervention (called BREEZE+) that includes three brief nurse-delivered sessions and access to a digital health app that teaches and reinforces patients' use of skills for managing and coping with this highly debilitating symptom. This study will lay the groundwork for a follow-up pragmatic implementation trial integrating BREEZE+ into usual oncology care for patients with advanced lung cancer experiencing dyspnea.

The Increase of Lung Capacity Using the Lung Master (Pulmonary Exerciser)

Investigators are studying how a device called The Lung Master device can help people breathe better. The investigational device increases the amount of air our lungs can hold, which is important for overall lung health. The Lung Master is not approved by the FDA. The study has two visits approximately one month apart. In the first visit participants will take a spirometry test, particularly forced vital capacity (FVC), to measure volume change in the lungs. Participants will take the investigational device home to use daily, either in the morning or evening. Use will be recorded in a diary. After one month, participants will return for another spirometry test. Each study visit will take about one to two hours to complete.

Dexamethasone in Controlling Dyspnea in Patients With Cancer

This phase II trial studies how well dexamethasone works in controlling dyspnea in patients with cancer. Dexamethasone may help control dyspnea (shortness of breath) and improve lung function and quality of life in cancer patients.

The Impact of Telemedicine, Using the Caller's Mobile Phone Camera, on the Quality of Care Provided to Adult Patients Contacting the 15 Centre for Acute Dyspnea

Dyspnea is the subjective sensation of difficult or uncomfortable breathing. It accounts for approximately 10% of emergency department visits and 8% of calls to Emergency Medical Communication Centers. Nearly half of patients presenting with dyspnea require hospital admission, 15% require ventilatory support, and approximately 5% die. Early recognition of signs of respiratory severity is therefore essential to accurately assess clinical urgency, guide diagnostic evaluation, and inform appropriate management decisions. In France, patients are encouraged to contact an Emergency Medical Communication Centers before presenting to an emergency department. Calls are managed by an emergency physician responsible for medical regulation, who performs a remote clinical assessment and determines the most appropriate level of care. Depending on the clinical evaluation, the physician may provide medical advice, refer the patient to an emergency department, dispatch emergency medical services, or send a physician-staffed mobile intensive care unit for life-threatening emergencies. The remote assessment of patients presenting with dyspnea is particularly challenging. The inability to directly observe or examine the patient, combined with the caller's difficulty in accurately describing the clinical situation, may impair the recognition of disease severity and result in inappropriate triage decisions, including under-triage and over-triage : Under-triage, characterized by failure to dispatch appropriate emergency resources or to refer the patient to an emergency department when indicated, may delay treatment and increase the risk of adverse outcomes, including mortality. Conversely, over-triage, defined as unnecessary referral to primary care or emergency departments or inappropriate dispatch of emergency resources, contributes to emergency department overcrowding, inefficient use of prehospital resources, and increased healthcare costs. In a previous study, the investigators demonstrated that video-assisted medical triage improved emergency physicians' ability to assess the severity of patients presenting with acute dyspnea. This telemedicine tool enables real-time transmission of a live video stream from the caller's smartphone camera to the emergency physician through a secure digital platform, providing direct visualization of the patient's clinical condition. By enhancing remote clinical assessment, video-assisted triage has the potential to reduce both under-triage and over-triage. In the present stepped-wedge cluster randomized trial, the investigators hypothesized that incorporating real-time video support into the medical regulation of adult patients contacting an Emergency Medical Communication Centers for acute dyspnea would improve the quality of medical decision-making compared with standard telephone triage alone.

Evaluation of the Effectiveness of the Cardiostory Device in Distinguishing Heart Failure From Other Causes in Patients Presenting With Dyspnea.

This is a prospective, observational study conducted in the emergency department. Adult patients presenting with dyspnea will be enrolled, and study data will be collected from routine clinical assessments, including medical history, physical examination, laboratory tests, and echocardiography results, as well as non-invasive cardiovascular measurements obtained using the CardioStory device.

Evaluation of the Effectiveness of the CardioStory Device in Distinguishing Heart Failure From Other Causes in Patients Presenting With Dyspnea

The CARDIOSTORY.TN study is a prospective observational study at Sahloul University Hospital (Sousse, Tunisia) evaluating the CardioStory device for distinguishing heart failure (HF) from other causes of acute dyspnea. Background: Dyspnea is common in emergencies, and differentiating cardiac from non-cardiac causes is often delayed by the limits of echocardiography and BNP tests. CardioStory is a rapid (\~2 minutes), non-invasive tool that measures cardiac filling pressure, a key HF marker. Objectives: Primary: Assess CardioStory's diagnostic accuracy. Secondary: Compare it with echocardiography and NT-proBNP, evaluate ease of use, and measure time to diagnosis. Methods: Adults (≥18) with acute dyspnea (\<7 days) included; unstable or traumatic/allergic cases excluded. CardioStory results will be compared to standard diagnostics. Sample size: 850 patients over 12 months. Outcome: If accurate, CardioStory could be a fast, practical diagnostic tool for emergency settings.

Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology

To learn about the effect of Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology (SPOT-ON) treatment on the severity of shortness of breath in patients with cancer.

Prognostic Value of Pulse Oximetry Differences

This prospective observational study aims to evaluate whether the difference between finger, earlobe and forehead SpO₂ (ΔSpO₂) measured at emergency department (ED) presentation is associated with clinical outcomes in adult patients presenting with dyspnea. We will compare ΔSpO₂ between patients with poor outcomes (death or intensive care unit \[ICU\] admission) and those with favorable outcomes. Secondary objectives include assessing the prognostic value of ΔSpO₂ for mortality, ICU admission, and lactate, and comparing its predictive performance with established early warning scores.

Lung and Heart Function Across Decades of Life in Health

The main objective of this study is to develop baseline "normal" reference values of both lung and heart function for healthy adults within the age range relevant to the United States Veteran population who served in the Southwest Asia theater of military operations. This study will involve performing key components of the Department of Veterans Affairs the Airborne Hazards and Open Burn Pit Center of Excellence (AHOBPCE) and a VA network of Post-Deployment Cardiopulmonary Evaluation Network (PDCEN) Core Clinical Evaluation in asymptomatic unexposed healthy controls without known lung or heart disease to serve as a "normal" control comparator group for veterans evaluated by PDCEN.

Videoconferencing for the Management of Paediatric Dyspnoea in an Emergency Medical Call Centre

Dyspnoea is defined as the sensation of difficult or uncomfortable breathing experienced by a patient. It is a significant concern in emergency care, accounting for 8% of calls to the emergency medical call centre (EMCC) and 10% of Emergency department (ED) admissions. Among paediatric patients, dyspnoea accounts from 14-27% of ED admissions, exhibiting notable seasonal variation. Approximately 10% of these patients require hospitalisation, and 1-3% of cases progress to respiratory failure. All these patients require a comprehensive clinical examination to accurately identify signs of severity, ensuring the timely initiation of specialized and effective treatment. In France, patients are encouraged to contact the local EMCC before visiting an ED. Medical dispatchers assess the clinical condition by phone, based on medical history, symptoms and current treatment. Based on this assessment, the medical dispatcher determines the appropriate decision which may include providing medical advice, directing the patient to an ED, or deploying a mobile intensive care unit (MICU). Seven percent of calls to an EMCC involve paediatric cases, with nearly half concerning children under six years of age with hyperthermia and dyspnoea as most complaints, particularly during epidemic periods. The medical assessment of paediatric dyspnoea by EMCC is particularly challenging. The inability of children to articulate their symptoms, coupled with parents difficulty in describing the situation - often exacerbated by anxiety - creates significant obstacles. Furthermore, the absence of a direct observation by the physician adds to the complexity and could lead to an inappropriate triage and management. Telemedicine uses communication technologies for remote consultations, electronic record management, and document sharing. It enables real-time visual evaluation, thereby improving diagnostic accuracy and decision-making. While evidence supports its benefits in managing adult dyspnoeic patients, further research is essential to validate its efficacy in paediatric settings, particularly within EMCC. This study will aim to evaluate the effectiveness of telemedicine within an EMCC and utilising real-time visualization in reducing inappropriate triage of children requiring care for acute dyspnoea.

Su Jok for Dyspnea and Fatigue

As the disease progresses, dyspnea and fatigue may increasingly interfere with daily activities, reduce patients' independence, and negatively affect their quality of life. Therefore, in addition to pharmacological treatment, there is a need for safe and supportive interventions to help alleviate these symptoms. This study aims to evaluate the effects of Su Jok therapy on dyspnea and fatigue in patients with chronic obstructive pulmonary disease (COPD). The findings are expected to provide evidence regarding the potential role of Su Jok therapy as a complementary intervention for symptom management. The results may contribute to improving patients' symptom control and quality of life while providing healthcare professionals with evidence to support clinical decision-making and nursing care.

Breathing Exercises for Dyspnea and Anxiety in Heart Failure

Heart failure is a leading cause of emergency department admissions, with dyspnea and psychological distress being among the most common presenting symptoms. This randomized controlled trial aims to evaluate the effect of nurse-guided diaphragmatic breathing and pursed-lip breathing exercises on dyspnea and psychological distress in patients presenting to the emergency department with heart failure. A total of 112 eligible participants will be randomly assigned in a 1:1 ratio to either an intervention group receiving breathing exercises in addition to standard care or a control group receiving standard care alone. Dyspnea severity will be assessed using the Modified Borg Dyspnea Scale, and psychological distress will be assessed using the Distress Thermometer at predefined time points. The findings are expected to provide evidence for the effectiveness of a simple, low-cost, nurse-led non-pharmacological intervention in improving symptom management in patients with heart failure.

SU JOK THERAPY TO IMPROVE DYSPNEA AND INSOMNIA IN ASTHMA

Asthma is a long-term lung disease that can make breathing difficult and can also affect sleep. Even with regular medical treatment, many people with asthma continue to experience shortness of breath and insomnia. This study will examine whether Su Jok therapy, a complementary therapy that applies gentle stimulation to specific points on the hands and feet, can help reduce shortness of breath and improve sleep in people with asthma. Adults with asthma who agree to participate will be randomly assigned to one of two groups. One group will receive Su Jok therapy in addition to their usual care, while the other group will receive usual care only. Researchers will compare changes in breathing difficulty and sleep quality between the two groups. The results of this study may help determine whether Su Jok therapy can be used as a safe and supportive treatment alongside standard asthma care.

A Stepped Intervention for Coping With Dyspnea in Patients With Lung Cancer-Phase A (Open Pilot)

Patients with lung cancer often experience shortness of breath, also known as dyspnea. It affects over 80% of patients with lung cancer at diagnosis and is linked to poorer quality of life and functioning. Unfortunately, current treatments-such as opioids, which are the most studied treatment for dyspnea-fail to provide patients with adequate care, and dyspnea can remain a chronic issue in many. Even when new treatments are developed, the benefit to public health is often limited by healthcare systems not having enough resources to use new treatments. The investigators' aim is to test a personalized treatment for dyspnea that can address patients' unique needs while efficiently using healthcare resources to make the treatment as accessible as possible for future widespread use. This project builds upon rhe investigators' prior work creating two promising psychological treatments for dyspnea. The first (a two-session behavioral treatment provided by nurses) targets dyspnea-related discomfort. The second (a five-session psychological treatment provided by psychologists) targets dyspnea-related anxiety and overall health outcomes. The investigators combined these complementary treatments with a stepped-care model into a treatment called INSPIRE. In INSPIRE, all patients will receive the brief treatment to learn basic behavioral coping skills to manage the discomfort of dyspnea before escalating to the more intensive treatment that focuses on providing patients with the confidence to cope with dyspnea and related anxiety, but only if patients' dyspnea does not improve after the first treatment. The investigators will first ask for initial feedback from patients who are receiving INSPIRE for dyspnea and the patients' study clinician to make sure the treatment and study procedures fit their needs. The investigators want to see if this approach can work in patients with lung cancer, is well-received, and shows early signs of improving dyspnea. The investigators' goal is to provide personalized relief for breathing difficulties while making the best use of healthcare resources. These findings will help the investigators learn more about how to support patients with dyspnea and provide information on how to further test INSPIRE. Additionally, this personalized supportive treatment for dyspnea may potentially help reduce the use of opioids currently used in the treatment of dyspnea.

Endoscopic Treatment

The placement of an endoprosthesis in the airways leads to rapid and dramatic clinical improvement in the majority of cases of central airway obstruction. However, the limited diversity of device shapes available on the market is a major limitation, as these devices are poorly adapted, or not adapted at all, to the patient's anatomy. The main consequences of this lack of congruity are stent migration and granulomatous inflammatory reactions. The investigators hypothesized that personalized endoprostheses could significantly reduce the complication rate and improve tolerability. In this randomized controlled trial, the investigators propose to evaluate whether personalized endoprostheses allow for better management of non-malignant central airway stenoses by comparing this new approach to standard care.

ER-VISION-AI Study

Prospective, multicenter, randomized, open-label, blinded-endpoint (PROBE-like) clinical trial evaluating whether physician-supervised Generative Pre-trained Transformer (GPT)-assisted multimodal diagnostic support improves diagnostic concordance in emergency department patients presenting with acute cardiopulmonary symptoms.

Prospective Multicentre Study on Symptoms in First-onset Bronchial Asthma in Children and Adolescents

Bronchial asthma may present with symptoms other than the commonly reported complaints (cough, chest tightness, shortness of breath and wheezing). Less common symptoms include chronic or recurrent productive cough, inspiratory dyspnoea or recurrent pneumonia. Children presenting with these symptoms are often diagnosed with asthma bronchiale and benefit from antiasthmatic management.

Diagnosis of Heart Failure in Chronic Obstructive Pulmonary Disease Using the Lung Ultrasound

Acute Heart failure (AHF) is a common cause of acute exacerbation of chronic obstructive pulmonary disease (AECOPD). This association is frequently underestimated with regard to the difficulty of clinical diagnosis. The investigators expect that the application of the lung ultrasound could be useful in this issue.

Improving Diagnostic Accuracy for Acute Heart Failure

Acute heart failure is a common reason for emergency department visits and hospitalization, but the diagnosis can be challenging because of non-specific symptoms and signs. The current diagnostic approach to acute heart failure has modest accuracy, leading to delayed diagnosis and treatment, which associate with worse prognosis. Prior work suggests diagnostic accuracy can be improved with the addition of multiple circulating biomarkers discovered through proteomics, and this study will derive and validate a multi-marker model to improve diagnostic accuracy for acute heart failure in the emergency department.

Contactless Ultrasound Data Acquisition in Emergency Departments to Discriminate the Origin of Dyspnea and Chest Pain

PAnDA-One is a prospective, multicenter, interventional study (10 centers, France) aimed at developing and validating a diagnostic support algorithm based on the ADx-One medical device, which non-invasively acquires thoracic vibrations using airborne ultrasound. The study will enroll 2,500 patients presenting to the emergency department with acute dyspnea or non-traumatic chest pain, divided into a development cohort (N = 1,500) and an independent test cohort (N = 1,000). The deep learning algorithm will be trained to discriminate cardiovascular from non-cardiovascular origins of symptoms, and its performance will be assessed by AUROC, sensitivity, and specificity against a final diagnosis established by an expert adjudication committee. Patient management will not be modified by study participation.

Ventilation/Perfusion PET/CT With Galligas and 68Ga-MAA for Regional Lung Function Assessment After Pulmonary Embolism

In patients with pulmonary embolism (PE), after three or six months of anticoagulation, persistent dyspnea and impairment of quality of life are observed in at least 30% of cases. The "RAMBO" trial is a French academic, multicenter, randomized (1:1 ratio), parallel arm, controlled, that aimed to assess the efficacy of pulmonary rehabilitation (PR) on the quality of life in patients with an acute symptomatic PE treated with anticoagulant therapy during at least 3 months and who present an impairment of quality of life and/or persistent dyspnea despite anticoagulant therapy. Ventilation/Perfusion (V/Q) PET/CT is a novel imaging modality for the assessment of regional lung function. The same carrier molecules as conventional V/Q imaging are used, but they are labeled with 68Gallium, a ß+ isotope, instead of 99mTc, allowing acquisition of images with PET technology. The EOLE study is an ancillary pilot study of the RAMBO trial, in which patients will benefit, in addition to the extensive work up scheduled as per study protocol, from a V/Q PET/CT scan before and after PR. The aim of the study is to assess the impact of PR on regional lung function with lung V/Q PET/CT imaging.