[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ahrf\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ahrf":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,67],{"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":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100645214","optimization-of-respiratory-effort-with-titrated-sedation-in-ahrf-100645214","NCT07679932","Optimization of Respiratory Effort With Titrated Sedation in AHRF","Optimization of Respiratory Effort With Titrated Sedation in Patients With Acute Hypoxemic Respiratory Failure - The OPTIREST Study","OPTIREST","Inclusion Criteria:\n\n* Age ≥18 years\n* PaO2\u002FFiO2 ratio ≤ 200;\n* PaCO2 \\\u003C 45 mmHg;\n* At least one symptom prompting the use of sedative-analgesic drugs according to the prescription of the attending physician: dyspnea and\u002For discomfort equal of greater than 4\u002F10 (Visual Analog Scale - VAS), respiratory rate equal or greater than 25 breaths per minute, PaCO2\\\u003C35 mmHg, pain (Numeric Rating Scale ≥ 4 or Behavioral Pain Scale - Non-Intubated ≥ 4);\n* Informed consent signature.\n\nExclusion Criteria:\n\n* Pregnancy;\n* Exacerbation of asthma or chronic obstructive pulmonary disease;\n* Chronic lung disease, requiring oxygen therapy at home;\n* Cardiogenic pulmonary oedema;\n* Hemodynamic instability (systolic blood pressure \\\u003C90 mmHg or mean arterial pressure \\\u003C65 mmHg) and\u002For lactic acidosis (lactate \\>5 mmol\u002FL) and\u002For clinically diagnosed shock;\n* Metabolic acidosis (pH \\\u003C7.30 with normal or hypocarbia);\n* Glasgow Coma Scale \\\u003C13;\n* Contraindications to esophageal balloon and\u002For EIT placement.",{"count":52,"type":21},40,"OBSERVATIONAL","Prospective, observational, monocentric study to assess the physiological effects of dexmedetomidine and remifentanil in spontaneously breathing patients with acute hypoxemic respiratory failure receiving high-flow nasal oxygen.",[28],"NOT_YET_RECRUITING","2026-06-25",{"date":33,"type":34},{"date":60,"type":21},"2026-07",{"date":62,"type":21},"2028-07",{"name":64,"class":65},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":66},"100625506","hemodynamic-effects-of-lung-collapse-and-overdistension-during-ards-100625506","NCT07423520","HemodynamIc eFfects of Lung Collapse and overdIstension During ARDS","HemodynamIc eFfects of Lung Collapse and overdIstension in Patients With Moderate-to-seVEre Acute Respiratory Distress Syndrome: the HI-FIVE Physiologic Study","HI-FIVE","Inclusion Criteria:\n\n* acute respiratory failure with onset \\\u003C 1 week from a predisposing risk factor, such as pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, or shock;\n* bilateral opacities on chest radiography and computed tomography or bilateral B lines and\u002For consolidations on lung ultrasound not fully explained by effusions, atelectasis, or nodules\u002Fmasses;\n* pulmonary edema not exclusively or primarily attributable to cardiogenic pulmonary edema\u002Ffluid overload, and hypoxemia\u002Fgas exchange abnormalities not primarily attributable to atelectasis;\n* PaO2\u002FFiO2 ratio ≤ 200 during invasive controlled mechanical ventilation;\n\nExclusion Criteria:\n\n* age \\\u003C18 years;\n* pregnancy;\n* signs of barotrauma or documented pneumothorax;\n* severe tachycardia (HR \\> 120 bpm) and severe lacticaemia (lac \\> 4 mmol\u002FL)\n* pre-existing decompensated heart failure (NYHA class 3-4 and\u002For documented left ventricular ejection fraction \\\u003C 35%);\n* contraindications to EIT placing (open chest wounds, presence of cardiac pacemaker);\n* intubation as a result of an acute exacerbation of chronic pulmonary disease;\n* contraindications to esophageal balloon placement (high bleeding risk, esophageal varices).",{"count":76,"type":21},20,[24],"The management ARDS relies on ventilatory strategies aimed at limiting ventilator-induced lung injury (VILI). The setting of PEEP is still subject of debate, as randomized clinical trials comparing standardized higher versus lower PEEP strategies failed to demonstrate a clear survival advantage. Only few studies explored the hemodynamic effects of various PEEP levels depending on lung recruitability. Furthermore, the role of PEEP-mediated lung collapse and overdistention on patients' hemodynamics has yet to be elucidated. In this physiologic study, the association between EIT-measured lung collapse and overdistention and cardiac function will be explored, accounting for the individual potential for lung recruitment, partitioned respiratory mechanics and cardiac preload responsiveness. Three PEEP levels will be tested in a randomized, crossover fashion: PEEP corresponding to the crossing point between lung collapse and overdistention, PEEP associated with low lung collapse, PEEP associated with low lung overdistention.",[80,28],"ARDS",[80,28,82,83,84,85,86,87,88,89],"acute respiratory distress syndrome","PEEP","collapse","overdistention","hemodynamics","heart-lung interactions","mechanical ventilation","randomized crossover trial","2026-02-14",{"date":92,"type":34},"2026-02-20",{"date":94,"type":21},"2026-02-28",{"date":96,"type":21},"2027-05-01",{"name":64,"class":65}]