[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ventilator-induced-diaphragm-dysfunction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ventilator-induced-diaphragm-dysfunction":58},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100629621","a-post-approval-multicenter-study-to-assess-the-continued-safety-and-effectiveness-of-the-aeropace-system-100629621",false,"NCT07477054","A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System","A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System - The AERO-PAS Study","AERO-PAS","Inclusion Criteria:\n\n1. Are 18 years or older, and,\n2. Will have been mechanically ventilated for ≥96 hours (4 days) by the time of Catheter insertion, and,\n3. Have not weaned from MV, and,\n4. Have failed an institutional SBT within 48 hours of enrollment.\n\nExclusion Criteria:\n\n1. Invasive mechanical ventilation \\>90 days.\n2. Currently on extracorporeal membrane oxygenation (ECMO).\n3. Weaning failure due to hypervolemia.\n4. Medical history (including imaging) or known anatomy that prevents percutaneous insertion of the Catheter into the intended thoracic vein on the left side.\n5. Clinically overt congestive heart failure that is preventing weaning.\n6. Currently being treated with neuromuscular blockade that could affect phrenic nerve \u002F diaphragm contraction.\n7. Pre-existing neurological, neuromuscular or muscular disorder that could affect the respiratory muscles.\n8. Pre-existing severe chronic pulmonary fibrosis.\n9. Known pleural effusions occupying greater than one third of the pleural space on either side.\n10. BMI \\>70 kg\u002Fm2.\n11. Known or suspected phrenic nerve paralysis.\n12. Any electrical device (implanted or external) that may be prone to interaction with, or interference from the AeroPace System, including neurological pacing\u002Fstimulator devices, cardiac pacemakers and defibrillators.\n13. Current hemodynamic instability\n14. Uncontrolled sepsis or septic shock.\n15. Current or untreated bacteremia.\n16. Expecting withdrawal of life support and\u002For shift to palliation as the goal of care.\n17. Known or suspected to be pregnant or lactating.\n18. Currently being treated in another clinical trial studying an experimental treatment that could affect the study primary outcome.","ALL","18 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"NA","A single-arm, prospective, multicenter cohort study to assess the 30-day continued safety and effectiveness of the AeroPace System in patients on mechanical ventilation (MV) at least 96 hours and who have not weaned. This is a study collecting real-world data in a post-market setting.",[27],"Ventilator Induced Diaphragm Dysfunction",[29,30,31,32,33],"VIDD","Diaphragm Atrophy","Weaning Failure","SBT","Phrenic Nerve Stimulation","NOT_YET_RECRUITING","2026-03-12",{"date":37,"type":38},"2026-03-17","ACTUAL",{"date":40,"type":21},"2026-07-01",{"date":42,"type":21},"2028-02-01",{"name":44,"class":45},"Lungpacer Medical Inc.","INDUSTRY",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":5},"100620921","evaluation-of-heepsync-a-novel-algorithm-for-transcutaneous-electrical-stimulation-of-respiratory-muscles-in-mechanically-ventilated-patients-100620921","NCT07363902","Evaluation of heepSync, a Novel Algorithm for Transcutaneous Electrical Stimulation of Respiratory Muscles in Mechanically Ventilated Patients.","Clinical Safety and Feasibility Study for Non-CE Marked Medical Device: Evaluation of heepSync, a Novel Algorithm for Transcutaneous Electrical Stimulation of Respiratory Muscles in Mechanically Ventilated Patients.","Inclusion Criteria:\n\nPatient population 1\n\n* Adult patients with acute hypoxemic respiratory failure who have been under controlled mechanical ventilation for at least 24 hours prior to enrollment.\n* Clinically stable: oxygen saturation \\> 90% with a fractional inspired oxygen ≤ 0.50, eternal PEEP ≤ 10 cm H2O, temperature ranging from 35.5 to 38.5 ºC, no intravenous administration of vasoactive agents.\n\nPatient population 2\n\n* Adult patients with acute hypoxemic respiratory failure who have been under pressure support mechanical ventilation for at least 24 hours prior to enrollment.\n* Clinically stable: oxygen saturation \\> 90% with a fractional inspired oxygen ≤ 0.50, eternal PEEP ≤ 10 cm H2O, temperature ranging from 35.5 to 38.5 ºC, no intravenous administration of vasoactive agents.\n\nExclusion Criteria:\n\n* Patients treated with neuromuscular blocking agents\n* Patients with neuromuscular disease\n* Patients with a pacemaker or past history of arrhythmia\n* Patients with physical obstacles that prevent thoracic or abdominal electrostimulation (e.g., abdominal trauma, recent abdominal surgery, polytrauma, broken or irritated skin)\n* BMI \\> 40 kg\u002Fm2\n* Hemodynamically unstable (noradrenaline \\>0.1 microgram\u002Fkg\u002Fmin)\n* Pregnancy\n* Patients under the age of 18\n* The formalized ethical decision to withhold or withdraw life support\n* Patient under guardianship\n* Patients deprived of liberties\n* Patients already enrolled in the present study, in a previous episode of acute respiratory failure.\n* The patient who does not consent.",{"count":54,"type":21},20,[24],"Up to 76% of ICU patients on mechanical ventilation develop significant respiratory muscle atrophy within the first 24 hours, contributing to prolonged ventilation, increased morbidity, and higher healthcare costs. To date, there is no practical, non-invasive technology that offers synchronized, personalized electrostimulation for both inspiratory and expiratory muscles during mechanical ventilation.\n\nHeecap is a medical product designed to provide transcutaneous electrical stimulation of the respiratory muscles (TERM) that are involved in inspiration and expiration, detecting those in which it is clinically relevant and safe to provide such stimulation in assisted respiration.\n\nThe following study aims to evaluate the safety and preliminary performance of the stimulation algorithm in mechanically ventilated patients in the ICU. This evaluation will specifically focus on the algorithm's ability to synchronize stimulation with the patient's breathing patterns, and on evaluating the safety and feasibility of the TERM in activating respiratory muscles.",[58,29,31],"Ventilator-induced Diaphragm Dysfunction",[60,61,62],"Transcutaneous Electrical Stimulation","Mechanical ventilation","respiratory muscles","RECRUITING","2026-01-15",{"date":66,"type":38},"2026-01-23",{"date":68,"type":38},"2024-12-01",{"date":70,"type":21},"2026-05",{"name":72,"class":45},"Tesai Care SL",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":98},"100403514","how-early-mobilization-impacts-on-diaphragm-thickness-in-critically-ill-children-100403514","NCT04534296","How Early Mobilization Impacts on Diaphragm Thickness in Critically Ill Children","A Randomized Control Trial Comparing the Effects of Early Mobilization and Routine Care on Diaphragmatic Thickness","Inclusion Criteria:\n\n* subjects \\> 6 months and \\\u003C 12 years of age；\n* subjects been intubated and mechanically ventilated for \\\u003C 24 hours at the time of screening;\n* the Glasgow Coma Scale (GCS) on admission of Pediatric Intensive Care Unit (PICU) is greater than 3\n\nExclusion Criteria:\n\n* cardiopulmonary arrest;\n* history of diaphragmatic paralysis or neuromuscular disease;\n* neuromuscular blockade;\n* expectation to be liberated from ventilator in \\\u003C 24 hours\n* history of mechanical ventilation in the last 6 months\n* presence of tracheostomy\n* high cervical spine injury\n* status convulsion\n* thoracic trauma when ultrasonic examination cannot be performed","6 Months","12 Years",{"count":83,"type":21},160,[24],"The objective is to compare the impact of early mobilization and routine care on diaphragm thickness in critically ill children",[87,58],"Mechanical Ventilation Complication","2025-02-11",{"date":90,"type":38},"2025-02-12",{"date":92,"type":38},"2021-04-26",{"date":94,"type":21},"2025-12",{"name":96,"class":97},"Children's Hospital of Fudan University","OTHER",1]