Diaphragm Condition

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Found 35 Actively Recruiting clinical trials

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RECRUITING

Mechanical ventilation is a life-support intervention crucial for saving lives in ICU patients. However, its prolonged use leads to deterioration in respiratory muscle strength and endurance, causing diaphragm dysfunction. This weakening is associated with prolonged mechanical ventilation and increased difficulty in weaning the patient from the ventilator, known as "difficult weaning." It has been reported that up to 20% of ICU patients require tracheostomy due to this issue. Tracheostomy is an invasive procedure that involves creating an ostomy in the trachea to establish an artificial airway, allowing for ventilation, facilitating weaning from mechanical ventilation, and improving secretion management. However, muscle dysfunction from disuse and lack of effective respiratory muscle training extends the tracheostomy duration, leading to hospital-acquired infections, swallowing disorders, and increased ICU and hospital days. Thus, respiratory muscle training is a key tool for enabling tracheostomy removal (decannulation) and improving respiratory system efficiency. Since no universally accepted training protocol exists, it is not a common practice in ICUs worldwide, including our country. This project proposes that applying an individualized inspiratory muscle training regimen combining strength and endurance exercises for two weeks could improve respiratory muscle performance, reducing decannulation time (days from tracheostomy placement to removal). The objective of this project is to assess the effect of an individualized inspiratory muscle training regimen, combining strength and endurance exercises for two weeks, on improving maximum inspiratory pressure, diaphragm thickness fraction, and its impact on successful decannulation time in patients with tracheostomy secondary to prolonged mechanical ventilation at HRLBO. Two groups of adult tracheostomized patients will be evaluated: an experimental group undergoing individualized inspiratory muscle training for 14 days plus standard physiotherapy, and a control group receiving standard physiotherapy and weaning guided by scheduled mechanical ventilation disconnection windows. Both groups will be compared in terms of decannulation time, ICU length of stay, hospital days, and quality of life survey scores. The study results will optimize the management of tracheostomized patients locally and nationally, reducing economic costs for both the country and patients and improving their quality of life, thus aiding in meeting some health objectives for the 2011-2020 decade.

18+ yearsAll GendersNA
1 location
C

RECRUITING

Chest radiography was introduced to medical practice over a century ago, shortly after the discovery of X-rays by Roentgen. Since then, it has been a key component of the health, screening, clinical evaluation, and the assessments of therapy for billions of people. To this day, chest radiography remains the most frequently ordered imaging test. In this 700-bed tertiary care hospital, over 100,000 chest radiographs are obtained annually. The technique of chest radiography has remained largely unchanged and is seen as a mostly qualitative rather than quantitative tool. Chest dynamic X-ray (DDR) is a new advanced version of chest radiography that provides important quantitative parameters such as lung motion, ventilation, and perfusion. With a dynamic scan of 20-30 seconds, sequential images of both lungs are obtained with high temporal resolution during breathing (7.5-30 frames per second), without increasing radiation dose. DDR utilizes a dynamic digital radiography (DDR) technique with a flat-panel detector (2-6) and generates images with a field-of-view (FOV) that can cover both lungs. DDR utilizes detectors with higher sensitivity than those typically used in conventional radiography, enabling multiple dynamic time frames to be obtained despite keeping the dose mostly unchanged. Compared to conventional radiography, computer analysis and image processing of the DDR sequential time frames provide additional valuable metrics that capture motion and other key functions of the lungs, while high-quality chest radiographs can also be generated from the recombined frames. Chest DDR can be performed in essentially any patient position, including standing or sitting, to capture lung physiology in a manner representative of daily life. Furthermore, DDR is inexpensive, requires minimal space, and enables high throughput, which can help reduce medical costs. While area-detector CT can provide a higher temporal resolution, its FOV cannot entirely cover both lungs and its radiation dose can be prohibitively high. Chest DDR offers a unique opportunity to provide dynamic imaging parameters for lung motion and function in a safe, practical, and cost-effective manner. Recently, the portable DDR technology has become available. This portable DDR scanner enables applications for non-mobile patients, like ICU patients. It allows the semi-quantitative or quantitative evaluation of pulmonary perfusion, ventilation, and diaphragmatic motion. ICU patients may have limited access to CT or MRI scanners due to the severity of their condition and/or to difficulties associated with support their devices (ECMO, LVAD, etc.), hence, why the portable DDR technology could have an especially meaningful impact on their care. The current Radiology team consists of Drs. Nishino, Wada, Valtchinov and Madore. The PI's group from Radiology will work in close collaboration with Dr. Frendl's research team in the BWH ICUs, as well as their biostatistician as multidisciplinary team of experts. They will also continue cooperation with Mr. Tsunomori and Mr. Yoneyama. These team members already have an established track record of successful collaboration with the PI. The investigators will use the observational study design where two diagnostic imaging modalities will be compared for their ability to best diagnose lung pathologies (i.e., diaphragmatic motion and lung aeration/ventilation, pulmonary perfusion, and lung water content). These imaging modalities are: (i) the current portable AP chest x-ray (CXR)-based diagnostic technique and (ii) the recently developed portable dynamic chest XR (DDR) technique. The DDR technology has yet to be proven to provide specific benefits for the care of the patients through the improved diagnosis of their pulmonary issues. Its ability to provide clinically meaningful additional information on aspects of lung pathologies (diaphragmatic motion and lung aeration/ventilation, pulmonary perfusion, and lung water content), that cannot be clearly discerned from the current portable CXR-based diagnostic technique, need to be documented; hence, the aims. This study design will compare the ability to diagnose those lung pathologies (atelectasis, pulmonary embolus, and pulmonary edema) as determined by either the DDR technology or the traditional qualitative portable routine AP CXR (the current standards of diagnosis) through images obtained via the two techniques at the same time points for each patient. The DDR imaging and analysis will provide both qualitative and semi-quantitative data for each patient at all time points. For this study, the patient's routine portable CXR will serve as the control image when applicable, and DDR images will serve as study images for each timepoint. For certain clinical conditions, the applicable gold standards will be used as controls, i.e. CT angiogram for pulmonary embolus, V-Q scans for lung ventilation and perfusion, and fluorographic swallowing studies for speech and swallow evaluation. Data derived from these studies will be expected to provide novel and clinically crucial (quantitative or semi-quantitative) information on the degree of diaphragmatic excursion when the patient is spontaneously ventilating vs. when ventilator support is provided. This would be crucial for decision making regarding the patient's readiness for extubation, or, inversely, when poor excursion of the diaphragms is detected for non-ventilated patients, it would support the decision for early implementation of ventilator support. Data on lung aeration would also factor into this decision-making process. Currently, quantitative or semi-quantitative data regarding these physiologic functions of the lungs are not available. Hence, why the investigators will focus on validating these novel metrics against clinical scenarios and outcomes. The investigators anticipate that this novel technology will better guide clinical decision making like the need for (or inversely, the safe removal of) ongoing ventilator support for our patients. Furthermore, the perfusion (blood flow assessment) component of the image analysis would provide invaluable (currently unavailable) diagnostic options for those patients for whom CT angiogram is not available to rule out/confirm pulmonary embolism (PE). CT angiogram is not available for patients who suffer from hemodynamic instability, or when it is clinically contraindicated, like patients with impending renal failure. The added value of the DDR technology for the diagnosis of larger PEs will be assessed in the later stages of this study.

18+ yearsAll GendersNA
1 location
C

RECRUITING

All clinically stable infants or pediatric patients up to 12 months of age admitted to the PICU with invasive respiratory support comply with the extubation readiness test (ERT) criteria are included after informed consent. After inclusion simultaneous monitoring of the diaphragm muscle function using transcutaneous diaphragm electromyography (dEMG) and diaphragm ultrasound (dUS) will take place while the patient is on spontaneous breathing mode during ERT. Transcutaneous diaphragm electromyography measurements are performed using three skin electrodes; two electrodes are bilaterally placed at the costo-abdominal margin in the nipple line and one at or above the sternum during a time period of 15 minutes, with a maximum of 30 minutes. Ultrasound examination is performed using a linear transducer, and micro-convex transducer by trained operators. The views are achieved with the patient in supine position. Diaphragm excursion (DE), diaphragm thickness (DT) and diaphragm thickening fraction (DTF) are measured, performed at three different breathing cycles within one examination event. After completion of the measurements analysis will be performed to evaluate the association between dEMG and dUS outcomes in this specific PICU population.

0-12 yearsAll Genders
1 location
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RECRUITING

RESEARCH STRATEGY Significance Injuries to the abdomen and pelvis can lead to significant morbidity and mortality in adult blunt trauma patients. Clinicians, concerned about abdominal and pelvic injuries, have increasingly utilized abdominal-pelvic (A/P) CT imaging of blunt trauma patients. CT imaging is compelling because of its documented high sensitivity in detecting injuries, and has lead some to recommend "pan-scan" imaging, which includes head, neck, chest and A/P CT imaging, of all blunt trauma patients. However, well-designed comparative trials have repeatedly failed to demonstrate improved patient outcomes thorough the use of "pan-scanning". It is hard to justify routine imaging if there is no benefit, particularly since A/P CT imaging is expensive and exposes patients to ionizing radiation and risk of lethal malignant transformation. As a consequence, recent recommendations emphasize the use of selective imaging in assessing most trauma patients. At the present time, there are no definite recommendations to guide selective A/P CT imaging of blunt trauma patients. In current practice, imaging decisions are typically based on clinical judgment, which suffers from poor specificity and substantial variability, making it an imprecise and unreliable tool. A rigorously develop decision instrument could provide substantial benefit in guiding selective A/P CT imaging. A decrease in CT utilization by as little as 10% would translate to substantial, direct, long-term benefits. There were approximately 1.5 million blunt trauma activation visits at the 1,632 adult trauma centers in the United States in 2015. Nearly half of these patients underwent abdominal-pelvic CT imaging, implying that nation-wide approximately 750,000 blunt trauma patients undergo A/P CT imaging each year. If a decision instrument could allow clinicians to safely forego at least 10% of these CTs, up to 75,000 CTs could be eliminated annually in the U.S. This reduction would provide cost and resource savings, reduced radiation exposure and iatrogenic cancers in the young vulnerable trauma population, and facilitate more efficient trauma evaluations, translating to shorter ED length of stay. Approach Investigators will employ the classic design strategy described by Stiell in developing the decision instrument. The development process includes separate derivation and validation phases. The clinical criteria identified in the derivation phase will form the basis of the instrument, with "high-risk" classification assigned to patients exhibiting one or more of the criteria, and "low-risk" classification assigned to patients who exhibit none of the criteria. Investigators will then conduct a separate validation assessment to determine whether the instrument retains optimal performance among a new cohort of patients. The validation phase will focus on ensuring that the final instrument has the high sensitivity and negative predictive value (NPV) needed to ensure its safe application, while retaining the highest possible specificity (and potential to decrease imaging). The primary goal of the study will be to develop an instrument that reliably identifies patients who have injuries of major clinical significance that are evident on A/P CT imaging. The injuries of interest in this goal include injuries that require intervention, as well as any injuries to the aorta (including those not requiring intervention), and select injuries to the spine. The secondary goal of the study will be to develop a tool that reliably identifies patients who have injuries of major or minor clinical significance. The injuries of interest related to this goal include injuries that require intervention, injuries that merit clinical observation, any injuries to the aorta, and select injuries to the spine. To be clinically reliable, the DI must exhibit a sensitivity and negative predictive value of 98% or greater. At this level of precision, the risk of unfavorable outcomes due to missed injuries is equivalent to the risk of lethal malignant transformation from the radiation exposure associated with increased imaging. Validating a 95% lower confidence bound of 98.0% for a measured NPV of 100.0% requires evaluations on 183 patients assigned "low risk" status by the instrument. Similar validation of the sensitivity requires evaluations on 183 patients who have sustained injuries of major clinical significance. Because "low risk" patients are more prevalent than those sustaining major injuries, the ultimate sample estimate is driven by the need to enroll 183 patients who have sustained major A/P injuries. Protocol Phase I - Derivation Clinicians will assess the presence or absence of each of the candidate criteria for each imaged patient during their initial emergency department evaluation. These assessments will be recorded prior to initiating CT imaging. The injury status of each patient will be based on final radiologic interpretation of the initial A/P CT imaging obtained in the ED. Investigators require that relevant injuries be evident on CT imaging because the risk classification assigned by the instrument is immaterial if an injury is not visible on CT imaging. Injuries will be further classified as being of major, minor, or insignificant concern based on review of the patients care during their index visit. The three level injury classification reflects the fact that many clinicians are comfortable in missing minor injuries provided that all injuries requiring intervention are identified, while other clinicians are uncomfortable using tools that occasionally miss minor injuries that require no intervention, and seek to identify all injuries regardless of their clinical significance. To accommodate these perspectives, investigators will employ identical techniques to develop a two separate decision instruments. The first, and primary goal of the study, is to develop an instrument that identifies all injuries requiring intervention, while a second goal is to create an instrument that identifies all significant injuries, whether they require intervention or not. Investigators will employ binary recursive partitioning to derive the decision instruments. The primary instrument must exhibit a sensitivity and negative predictive value greater than 98.0% in detecting and excluding major injuries. The second instrument must exhibit similar sensitivity and NPV in detecting and excluding major and minor injuries. Phase II - Validation In the second phase of the study, investigators will apply the instruments to a new cohort of blunt trauma patients to assess their performance and determine whether they retain sufficient sensitivity to support their use as A/P CT decision tools. Clinicians will again document the presence or absence of criteria during their initial emergency department evaluations, and record their impressions prior to imaging. Investigators will base the presence or absence of injury on the final radiologic interpretation of the initial A/P CT imaging obtained in the ED. Injuries will be further classified as being of major, minor, or insignificant concern based on review of the patients care during their index visit. The primary outcome will be the sensitivity of the instrument in classifying as "high-risk" all patients harboring injuries of major importance. Investigators will also calculate the NPV, specificity, and count the number of "low-risk" patients for whom imaging might have been safely omitted had the decision instrument been implemented. The secondary outcome will be to perform a similar analysis focused on identifying patients with injuries major or minor clinical significance, and will measure the sensitivity, NPV, specificity, and potential to reduce imaging using this additional version of the instrument. Data Collection Criteria assessments. Physicians will assess the status of the individual criteria during their initial emergency department evaluations and prior to ordering CT imaging. Investigators will record demographic information for each patient, along with the clinician assessments of the presence or absence of potential predictor variables. The potential predictor variables include abdominal pain or tenderness, flank pain or tenderness, pelvic pain or tenderness, hip or iliac pain or tenderness, midline lumbar spine or sacral pain, abnormal alertness, evidence of intoxication, distracting painful injury, and hypotension. Investigators will also record historical information and emergency department vital signs measurements. Data collection during the validation phase will follow a similar process, but will be limited to demographic information and the criteria that compose the decision instruments. Patient outcomes. The presence of significant major or minor injuries will be based on final radiologic interpretation of the initial CT imaging obtained in the ED. The classification into major or minor status will be based on review of the patients care during their index visit to determine whether the patient underwent any interventional procedures. All injury assessments will be completed by trained investigators blinded to criteria assessments and final classification by the decision instrument. Investigators require that relevant injuries for the study must be evident on CT imaging because risk classification assigned by the instrument is immaterial if an injury is not visible on CT imaging. Injuries of major clinical significance consist of all abdominal and pelvic injuries requiring intervention, as well as any injury to the aorta, and any injury to the spine involving instability or neurological compromise. Injuries that require only observation, but no intervention, will be considered clinically minor, provided they do not involve the aorta or spine, while injuries that required neither intervention nor observation, and that do not involve the aorta or spine will be considered insignificant. Formulation of the optimal A/P CT decision instrument. Investigators will treat each individual criterion as a dichotomous variable. For analytic purposes in the derivation phase, each variable will be considered negative (normal) unless it can be assessed and found to be abnormal. Thus, variables that cannot be measured in an individual patient (such as coagulopathy in an unconscious individual) will be documented as "unable to assess" and treated statistically as negative. This will ensure that the derivation process is based on observed assessments and is as robust as possible. Investigators will use the individual criteria to construct the nodal points of the recursive partitions. Investigators will employ binary recursive partitioning to identify a combination of candidate criteria that predicts significant abdominal-pelvic injuries with \> 98.0% sensitivity, excludes significant injuries with \> 98.0% NPV, and retains the greatest specificity. Sensitivity will be used as the outcome measure for constructing the partitions. Investigators will terminate the partitioning under the following circumstances: 1) partitioning produces an instrument exhibiting a sensitivity of 100.0%, 2) partitioning exhausts all patients without developing a sufficiently sensitive rule, 3) partitioning exhausts all variables (criteria) without identifying a sufficiently sensitive rule. Circumstance I will confirm the hypothesis driving the first specific aim. Circumstance 2 and 3 may confirm the first hypothesis, provided the lower confidence limit of for the sensitivity of the resultant rule exceeds 98.0%, otherwise these circumstances will be interpreted to refute the first hypothesis. Investigators will create two distinct decision instruments. The first, and primary instrument will focus on identifying only those patients having injuries of major clinical significance. Investigators will also develop a second instrument that identifies patients having injuries of either major or minor significance. Validation of the A/P CT decision instrument. The validation phase will again treat each individual criterion as a dichotomous variable. Each variable will be considered negative (normal) only if it is assessed and found to be normal. Variables that cannot be measured in an individual patient (i.e. coagulopathy in an unconscious individual) will be documented as "un-assessable" and treated statistically as positive. This ensures that patients will be assigned low-risk status only if all criteria are adequately assessed and found to be negative. Patients will be excluded from low-risk classification (and assigned high-risk status) if they have one or more positive or un-assessed criteria. This requirement ensures patients are not assigned low-risk status on the basis of an inadequate assessment. Using the final risk assignments and patient outcomes, investigators will assign each case to one of the following four categories: 1 - true-positive status (injured patients classified as "high-risk" by the DI); 2 - false-negative status (injured patients classified as "low-risk" by the DI); 3 - false-positive status (uninjured patients classified as "high-risk" by the DI); and 4 - true-negative status (uninjured patients classified as "low-risk" by the DI). Investigators will employ these values to calculate point measures and 95 percent confidence intervals for sensitivity, NPV and specificity of the decision instrument. Investigators will consider the instrument to be validated if the lower 95% confidence interval for its measured sensitivity exceeds 98.0%. Assessing the potential to decrease A/P CT imaging. Investigators must assess whether application of the tool to blunt trauma patients actually has the potential to decrease A/P CT imaging. Because of the tool's inherent sensitivity, "low risk" patients will be free of injury and receive no benefit from imaging. They are ideal candidates to exclude from imaging. Thus, measuring the proportion of "low-risk" patients will provide the investigators with an estimate of potential imaging reductions. Reductions in charges and radiation exposure will be determined by respectively summing radiographic charges and life-time decreases in radiation morbidity and mortality for all "no risk" cases.

All Genders
1 location
D

RECRUITING

Evidence both from animal and human studies support the development of ventilator induced diaphragm dysfunction (VIDD) from as early as 24 hours of mechanical ventilation (MV) in the intensive care unit (ICU). However, while the concept of VIDD seems to be proven now, several questions remain unanswered regarding its actual rate of development and (potentially) recovery after MV. The gold standard of twitch transdiaphragmatic pressure recordings would ultimately clear the fog around the rate of development of VIDD over time. Through measurements made even after MV it could be clarified to what extent patients recover from VIDD. Paired with cortical stimulation and electromyographic recordings of diaphragm muscle potentials, it could be explored to what extent decreased diaphragm excitability due to long term MV contributes to VIDD on the level of motor cortex. Against that background the present project aims at determining the rate of decline in diaphragm function, strength and control in patients undergoing MV (including measurements after extubation).

18-75 yearsAll Genders
1 location
D

RECRUITING

INTRODUCTION AND RATIONALE The diaphragm is a dome-shaped muscle which separates the thoracic cavity from the abdomen. It is the most important muscle of respiration innervated by the phrenic nerves. While many diseases might interfere with its function (1), in the intended study the investigators will focus on diaphragm paralysis due to phrenic nerve injury. Two types of diaphragm paralysis can be distinguished: unilateral and bilateral. Patients with unilateral paralysis perceive exertional dyspnea, have an impaired exercise capacity and orthopnea.(2) Patients with a bilateral paralysis usually have more symptoms and might even develop respiratory failure. (3) In addition, all patients with a diaphragm paralysis may have poor sleep quality, as the diaphragm is the only active respiratory muscle during REM sleep. (4) Currently, two treatment approaches for patients with diaphragm paralysis are used in clinical practice: surgical diaphragm plication and nocturnal non-invasive ventilation (NIV). Plication is a minimal invasive surgical procedure that aims to stiffen the diaphragm and such limits dysfunctional (paradoxical movement) excursions of the paralytic diaphragm. The procedure is performed in ±70 patients per year in the Netherlands. NIV is a non-invasive mode of positive pressure ventilatory assistance; through a facial mask the ventilator supports patient breathing effort. Patients with diaphragm paralysis use their ventilator mainly during night time, to improve quality of sleep and such to reduce day time symptoms. In the Netherlands, home mechanical ventilation is very well organized, as care is delivered by only 4 specialized centers. NIV for diaphragm paralysis is started in around 50 patients yearly. Currently, both plication and nocturnal NIV appear beneficial and both options are covered by health care insurance. However, it is unknown which intervention is most beneficial from a patient perspective. For instance, comparison on patient relevant outcome measures and complications between these treatment approaches is unknown. In addition, patients with diaphragm paralysis may develop severe symptoms, limiting daily activities including ability to perform their professional work. To assess the overall impact of this a detailed cost analysis is necessary to compare both treatments from a societal perspective. A solid cost effectiveness / cost utility study will reveal which therapy is the best option from a societal perspective. This pilot study will be set up as an intervention study.To know what clinical effect of both therapies is relevant the EQ-5D-5L is used. It is unknown whether there is a significant difference on the outcome between both therapies. A search in trial registries did not reveal any study with similar research questions. Based on the outcomes of this preparatory study a power analysis can be performed for the seminal study. Due to the acute origin of a diaphragm paralysis patients get suddenly severely impaired which is interfering enormously with their lives. As this is often happening in middle aged patients they often have to discontinue professional activities. This means that the potential impact of this disorder is huge from patient and societal perspective and needs to be assessed. As both therapies are completely different for invasiveness, the investigators need to compare the side effects and possible complications. Possible complications of the surgery are infection, bleeding and abdominal pain while the well know side effects of ventilatory support are leakage of the mask, aerophagia and a-synchrony between breathing pattern of the patient and the ventilator. As this is also an important outcome of this pilot study participants will be closely monitored from the start of therapy and there will be a telephone call after 2 months

18+ yearsAll GendersNA
1 location
D

RECRUITING

Mechanical ventilation has been linked to diaphragm injury and dysfunction. During mechanical ventilation, the amount of breathing work done by the diaphragm is unpredictable: the diaphragm could be completely rested, or it could be overworked. Either of these possibilities may cause injury to the diaphragm. Patients with an injured and dysfunctional diaphragm have greater difficulty weaning from mechanical ventilation - they become too weak to breathe. However, little is known about the relationship between changes in the diaphragm and the histological (structure of cells and tissue) basis of these changes. The investigators have developed a new technique employing beside ultrasound to measure diaphragm thickness. This allows them to observe changes in diaphragm muscle structure and function. The goal of the study is to determine whether different forms of respiratory support (mechanical ventilation vs extracorporeal life support) lead to different degrees of diaphragm injury and to compare changes in the diaphragm seen on ultrasound to changes in the diaphragm tissues under a microscope. This will help the investigators to confirm the best way to avoid diaphragm injury and to understanding the meaning of diaphragm ultrasound images.

18+ yearsAll Genders
1 location
D

RECRUITING

Healthy Volunteer

Low back pain is one of the most common musculoskeletal problems, limiting daily life activities, leading to loss of productivity, and significantly reducing quality of life. In non-specific low back pain, insufficient stabilization in the trunk region and inadequate activation of deep muscles reduce the effectiveness of functional movements and contribute to chronic pain. The diaphragm, a crucial component of trunk stability, plays a critical role not only in respiratory function but also in maintaining spinal stability through the regulation of intra-abdominal pressure. Dysfunction or insufficient relaxation of the diaphragm can lead to changes in breathing patterns, impaired postural control, and persistent low back pain. Therefore, a better understanding of the diaphragm's role in low back pain mechanisms and its targeting in therapeutic interventions is becoming increasingly important. This study aims to investigate the effects of diaphragm relaxation techniques, applied in addition to spinal stabilization exercises, on pain intensity, disability level, quality of life, central sensitivity, and trunk muscle endurance.

18-65 yearsAll GendersNA
1 location
E

RECRUITING

Synthetic mesh has reduced hernia recurrence but is associated with significant complications in contaminated fields and high-risk patients. Biologic meshes offer potential advantages including biocompatibility, resistance to infection, and tissue remodeling. High-Purity Type I Collagen (\>97% purity) is an un-crosslinked, resorbable scaffold designed to support host tissue integration. This prospective observational study systematically evaluates early clinical outcomes following HPTC-reinforced hernia repair, including surgical site infection, wound healing, postoperative pain, and early integrity of repair. The study is not designed to assess long-term recurrence.

18-75 yearsAll GendersNA
1 location
E

RECRUITING

Healthy Volunteer

This crossover trial, single-blind, bicentric study will be conducted at two hospitals. Adult volunteers aged 18 to 60 years, healthy, with a body mass index between 18.5 and 24.9 kg/m2, without a history of previous respiratory diseases, and without contraindications to undergo evaluation or application of the proposed electrical stimulation modalities will be included. Participants' diaphragm muscle will be assessed using ultrasound for variables such as thickness, thickness fraction, and diaphragm mobility. Patients will be randomized using opaque envelope draw prior to evaluation into two distinct experimental moments: 1) "TEPNS" moment - application of the TEPNS protocol; or 2) "TEDS" moment - application of the TEDS protocol. Additionally, data regarding the feasibility and safety of the application of electrical stimulation modalities will be collected.

18-60 yearsAll GendersNA
1 location

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