[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lungpacer Medical Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100580054","stimulation-to-activate-respiration-100580054",false,"NCT06832306","STimulation to Activate RespIration","A Clinical Study Evaluating Temporary Transvenous Diaphragm Neurostimulation in Mechanically Ventilated Patients With Acute Hypoxemic Respiratory Failure","STARI","Inclusion Criteria:\n\n1. Male or female, 18 years or older, and\n2. Able to provide informed consent or have a legally authorized representative (LAR) \u002F Substitute Decision Maker (SDM) who can provide consent, and\n3. Have acute onset of new respiratory symptoms or dysfunction within the 2 weeks before onset of need for respiratory support, and\n4. Have arterial hypoxemia defined by one of:\n\n   * PaO2:FiO2 ratio ≤300 mm Hg on PEEP ≥5 cm H2O, or\n   * In the absence of an available arterial blood gas, SpO2 ≤97% on FiO2 ≥0.5 and PEEP ≥5 cm H2O with reliable SpO2 trace for the 2 hours immediately preceding eligibility assessment (this correlates to an upper limit of SpO2:FiO2 ratio of 316%) or\n   * Are receiving pulmonary vasodilators for acute hypoxemia, or\n   * Are being ventilated in the prone position for acute hypoxemia, and\n5. Have been mechanically ventilated for AHRF in the ICU for \\\u003C96 hours at the time of enrolment, and\n6. Are expected to require invasive mechanical ventilation ≥48 hours after enrollment in the opinion of the treating clinician\n\nExclusion Criteria:\n\n1. Hypoxemia is primarily attributable to acute exacerbation of chronic obstructive pulmonary disease, status asthmaticus, cardiogenic pulmonary edema, or pulmonary embolism.\n2. Underlying chronic parenchymal lung disease that may make recovery\u002Fextubation a challenge (e.g., COPD, pulmonary fibrosis).\n3. Broncho-pleural fistula at the time of eligibility assessment.\n4. Require extracorporeal membrane oxygenation.\n5. Pre-existing neurological, neuromuscular or muscular disorder or known phrenic nerve injury that could affect the respiratory muscles.\n6. BMI \\>70 kg\u002Fm2.\n7. Contraindications to left internal jugular vein or left subclavian vein catheterization (e.g., infection at the access site, known central venous stenosis, septic thrombophlebitis, left internal jugular ECMO cannula in situ, poor target vessels).\n8. Patient expected to transition to fully palliative care within 72 hours of enrollment.\n9. Chronic severe liver disease (e.g., Child-Pugh Score ≥10)\n10. Treating clinician deems enrollment not clinically appropriate.\n11. Currently enrolled in any other study of an investigational drug or device, which may affect the outcomes of the current study.\n12. Any electrical device (implanted or external) that may be prone to interaction with or interference from the AeroNova System, including neurological pacing\u002Fstimulator devices and cardiac pacemakers and defibrillators.\n13. Known or suspected to be pregnant or lactating.","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","Multi-center, randomized, controlled, open-label Phase 2 feasibility trial. Subjects on mechanical ventilation (MV) for acute hypoxemic respiratory failure (AHRF) with lung injury (including subjects who meet criteria for acute respiratory distress syndrome (ARDS)) will be randomized 2:1 to diaphragm neurostimulation-assisted ventilation (DNAV) using the AeroNova System plus lung-protective ventilation (Treatment) vs. lung-protective ventilation alone (Control).",[27,28,29],"ARDS (Moderate or Severe)","AHRF","Mechanically Ventilated ICU Patients","RECRUITING","2026-06-30",{"date":33,"type":34},"2026-07-01","ACTUAL",{"date":36,"type":34},"2025-05-28",{"date":38,"type":21},"2026-12",{"name":40,"class":41},"Lungpacer Medical Inc.","INDUSTRY",7,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100629621","a-post-approval-multicenter-study-to-assess-the-continued-safety-and-effectiveness-of-the-aeropace-system-100629621","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.",{"count":52,"type":21},120,[24],"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.",[56],"Ventilator Induced Diaphragm Dysfunction",[58,59,60,61,62],"VIDD","Diaphragm Atrophy","Weaning Failure","SBT","Phrenic Nerve Stimulation","NOT_YET_RECRUITING","2026-03-12",{"date":66,"type":34},"2026-03-17",{"date":33,"type":21},{"date":69,"type":21},"2028-02-01",{"name":40,"class":41},""]