Diaphragm Condition

This research aims to evaluate the effects of a personalized inspiratory muscle training program on patients with tracheostomy due to prolonged mechanical ventilation. It focuses on improving maximum inspiratory pressure, diaphragm thickness fraction, and shortening the time needed to remove the tracheostomy tube. The study compares two groups of adult patients: one receiving this special muscle training combined with standard physiotherapy, and a control group receiving only standard physiotherapy with guided weaning from mechanical ventilation. The goal is to optimize patient care, reduce hospital stays and costs, and enhance quality of life. Participants in the experimental group will follow an individualized inspiratory muscle training program combining strength and endurance exercises for 14 days alongside standard physiotherapy. The control group will follow the usual weaning protocol, starting with shorter mechanical ventilation disconnection periods and gradually increasing them, plus training at 50% of their maximum inspiratory pressure after weaning. The intervention adjusts training based on patients’ respiratory status, with evaluations replacing training sessions as needed to avoid overexertion. During the study, patients will be monitored for respiratory muscle strength, diaphragm thickness, and diaphragm movement over two weeks. Researchers will also track the time to successful decannulation, length of ICU and hospital stays, and quality of life through surveys. Safety criteria include suspending training if patients show signs of respiratory distress. Overall participation lasts at least two weeks, with ongoing assessments to measure treatment impact and patient progress.

This research aims to evaluate the safety and performance of the ECLIPSIUM device in securing mesh during ventral hernia repair. It compares ECLIPSIUM, a bioresorbable polymer-based fixation device, to bioresorbable tacks to determine if it can reduce the risk of hernia recurrence. The study is a prospective, multi-center, randomized, single-blind trial designed to assess whether ECLIPSIUM offers clinical benefits in laparoscopic intraperitoneal onlay mesh ventral hernia repair procedures. Participants will receive one of two treatments: the ECLIPSIUM System, which applies a biodegradable polymer coating to the mesh and secures it with photoactivation using a special curing light, or resorbable tacks that fasten the mesh and are absorbed by the body over time. Each participant undergoes laparoscopic ventral hernia repair with mesh fixation using either method. The study will monitor outcomes over 12 months, including hernia recurrence and complications. During the study, participants will have assessments at 6 and 12 months to check for hernia recurrence and any complications. The trial includes follow-up visits and evaluations to monitor safety and effectiveness. Participants will be observed for the cumulative incidence of complications up to 12 months, and the primary outcome measurement is hernia recurrence at 6 months. The total duration of participation will vary depending on individual follow-up schedules.

Researchers are evaluating the use of portable dynamic digital radiography (DDR), a new advanced chest X-ray technology, in intensive care unit (ICU) patients. DDR captures dynamic images of lung motion, ventilation, and perfusion at a high frame rate, potentially providing more detailed and quantitative lung function information compared to traditional chest X-rays. This trial aims to test the feasibility and safety of portable DDR in the ICU and to compare its diagnostic value with current standard imaging methods. Participants will receive one to three sets of DDR scans, including 7-second breathing and breath-holding scans. These images will be compared to gold standard clinical exams such as chest X-rays, CT scans, or ventilation-perfusion (VQ) scans. The study will observe how DDR performs in diagnosing lung conditions like diaphragmatic dysfunction, pulmonary embolism, and pulmonary edema, alongside routine clinical imaging. Throughout the study, participants will undergo DDR imaging alongside their routine clinical imaging. Researchers will analyze these images to measure lung motion, diaphragmatic movement, and perfusion. The primary outcomes include assessing the precision of DDR in evaluating cardiopulmonary functions related to the diaphragm and lung motion as well as pulmonary blood flow, over a period of up to two months. The study will monitor safety and diagnostic accuracy while patients receive standard care.

Researchers are studying the relationship between two non-invasive ways to observe the diaphragm muscle function in infants and young children who need breathing support in the Pediatric Intensive Care Unit (PICU). The study focuses on children from birth up to 12 months old who are on invasive respiratory support and are ready for extubation. It aims to understand how diaphragm electromyography (dEMG) and diaphragm ultrasound (dUS) measurements relate to each other in this patient group. The study involves monitoring the diaphragm muscle using two techniques at the same time while the patient breathes spontaneously during the extubation readiness test. dEMG is recorded with three skin electrodes placed around the chest and sternum for 15 to 30 minutes. Ultrasound is performed by trained operators using specific probes to measure diaphragm movement and thickness during three different breaths. These measurements help assess the diaphragm's role in breathing. Participants will undergo simultaneous dEMG and ultrasound assessments while stable and breathing on their own. The study collects data on diaphragm muscle activity and structure to analyze their association. Researchers will measure and compare diaphragm electrical activity and ultrasound parameters over about one year. The study includes consent, and patients participate only once. Safety and clinical stability are monitored throughout the process.

Unrecognized abdominal and pelvic injuries from blunt trauma can lead to serious disability or death. Physicians often use computed tomography (CT) scans on many blunt trauma patients to avoid missing injuries, but this exposes many patients to radiation and high costs while finding injuries in only a few. Researchers are evaluating a decision tool to identify "low-risk" patients who may safely avoid CT imaging without missing significant injuries, aiming to reduce unnecessary scans, radiation exposure, and healthcare costs. This observational study involves adult blunt trauma patients who receive abdominal-pelvic CT scans in the emergency department. Physicians will record clinical signs and symptoms such as pain, tenderness, bruising, vital signs, and injury mechanism before imaging. The study will develop and validate decision instruments to classify patients as high or low risk for major or minor abdominal and pelvic injuries based on these clinical findings, without altering standard medical care. Participants will undergo routine clinical evaluations and CT imaging as part of their emergency care. Researchers will analyze the presence or absence of injuries using CT results and patient outcomes to assess the accuracy of the decision instruments. The main outcomes are the instruments' ability to correctly identify major and minor injuries. The study aims to confirm that these tools can safely reduce CT imaging, lowering radiation exposure and costs while maintaining patient safety.

Researchers are investigating the development and recovery of ventilator induced diaphragm dysfunction (VIDD) in patients who require mechanical ventilation (MV) in the intensive care unit. This observational study aims to understand how diaphragm function, strength, and control decline over time during MV, including after removal of the breathing tube. The study also explores whether decreased diaphragm responsiveness from long-term MV affects the brain's motor control of the diaphragm. Participants undergo detailed respiratory muscle testing, including measurements of twitch transdiaphragmatic pressure triggered by magnetic stimulation of the phrenic nerves, and assessments of cortical control of diaphragm function. These tests are performed first within 48 hours of starting MV, then every three days, including two sessions after extubation. Additional evaluations include diaphragm ultrasound and monitoring of systemic inflammation. During the study, patients will have repeated assessments to track changes in diaphragm function and brain control over two years. Researchers will measure twitch pressures, diaphragm muscle activity, and inflammation markers. This helps clarify the rate of diaphragm decline and potential recovery after MV. The study is sponsored by RWTH Aachen University and involves close monitoring of patients in critical care settings.

Researchers are evaluating two treatment options for patients with unilateral diaphragm paralysis caused by phrenic nerve injury: surgical diaphragm plication and nocturnal non-invasive ventilation (NIV). This pilot study aims to determine the clinical effects of both therapies on quality of life, measured by the EQ-5D-5L questionnaire, and to understand the costs of each treatment from a societal perspective. The study is open-label and involves 20 participants aged 18 years and older. Participants will be divided into two groups, with 10 receiving surgical plication, a minimally invasive procedure to stiffen the diaphragm and reduce its abnormal movement, and 10 receiving nocturnal NIV while waiting for surgery. NIV supports breathing through a facial mask during sleep to improve sleep quality and reduce daytime symptoms. Both treatments are currently used in practice, but their comparative effects on patient outcomes and complications are not yet known. During the study, participants will be closely monitored through various assessments including the EQ-5D-5L quality of life questionnaire at baseline, 3 months, and 6 months, as well as tests like the Medical Research Council dyspnea scale, Diaphragmatic Paralysis Questionnaire, Borg dyspnea score, 6-minute walk test, spirometry in sitting and lying positions, polysomnography, and overnight carbon dioxide and oxygen saturation measurements. Safety monitoring will include follow-up calls and assessment of side effects related to both surgery and ventilation. The total study duration covers up to 15 months to capture outcomes and costs.

Researchers are studying changes in the diaphragm's structure, function, and biology in patients who are supported by mechanical ventilation or extracorporeal life support as they wait for lung transplantation. The study aims to understand how these different respiratory support methods may cause diaphragm injury and how these injuries relate to tissue changes seen under a microscope. This research may help improve methods to prevent diaphragm damage and interpret ultrasound images of the diaphragm. Participants include patients receiving mechanical ventilation or extracorporeal life support as a bridge to lung transplant, patients undergoing lung transplantation without prior respiratory support, and patients having elective thoracic surgery for lung or esophageal resection. The study uses bedside ultrasound to measure diaphragm thickness and compares these findings to tissue samples obtained during transplantation or surgery. During the study, participants will have ultrasound assessments to track diaphragm thickness and function, and tissue samples will be examined microscopically to identify structural changes. Researchers will monitor diaphragm thickness changes at baseline and 7 days after lung transplant, and assess biomarkers related to diaphragm dysfunction before transplantation. The study is observational, and participants are involved through routine clinical procedures and additional ultrasound and tissue evaluations.

Low back pain is a common musculoskeletal issue that can greatly reduce quality of life by limiting daily activities and causing chronic discomfort. This study focuses on people with chronic non-specific low back pain, where poor core stability and diaphragm dysfunction may worsen symptoms. Researchers aim to explore how adding diaphragm relaxation to spinal stabilization exercises affects pain, disability, quality of life, central sensitization, and trunk muscle endurance. Participants will be randomly assigned to one of two groups. One group will receive spinal stabilization exercises three times a week for eight weeks, while the other group will do the same exercises plus manual diaphragm relaxation three times a week for the same duration. The study is designed with triple masking to reduce bias in the results. During the study, pain severity, disability, quality of life, central sensitization, and trunk muscle endurance will be measured at the start and after the eight-week intervention. Participants will engage in regular exercise sessions, and researchers will monitor their progress and responses to treatment. The total participation time spans the eight weeks of intervention, allowing for assessment of changes related to the added diaphragm relaxation technique.

Researchers are studying adult patients who are undergoing mechanical ventilation and preparing to be weaned off the ventilator. The study focuses on evaluating diaphragmatic effort and movement during a spontaneous breathing trial (SBT), which involves no assistance from the ventilator. The goal is to explore new ways to assess diaphragm function using diaphragmatic longitudinal strain (LSdi) and strain rate (LSRdi) alongside existing measurements, to help detect diaphragmatic dysfunction earlier. Participants will be monitored during a spontaneous breathing trial lasting between 30 and 120 minutes, using continuous positive airway pressure (CPAP) with zero pressure support. Researchers will measure diaphragm function parameters, including diaphragmatic strain (LSdi, LSRdi), thickening fraction (TFdi), and airway occlusion pressures (94P0.1 and 94Pocc). These measurements will be taken at baseline before the trial, and then at 2 minutes (early), 15 minutes (intermediate), and 30 minutes (late) after the trial starts. During the study, patients will undergo regular assessments of diaphragm function using non-invasive imaging and pressure measurements. The research team aims to monitor changes in diaphragmatic longitudinal strain and strain rate throughout the SBT over a 7-day observation period. This detailed monitoring will help evaluate how the diaphragm performs during weaning from mechanical ventilation. Participants' safety and clinical condition will be observed throughout the study period.