[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"barotrauma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:barotrauma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,73],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100492836","barotrauma-in-hyperbaric-oxygen-therapy-100492836",false,"NCT05697328","Barotrauma in Hyperbaric Oxygen Therapy","Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy","HBOT","Inclusion Criteria:\n\n* New patient requiring HBOT (either inpatient or outpatient)\n* Age greater than or equal to 18 years and less than 80 years\n* Fluent in English\n* Full decision capacity\n* Able and medically cleared to swallow a pill\n\nExclusion Criteria:\n\n* Enrollment would delay hyperbaric therapy more than 30 minutes in patients with emergent indications (example: Central Retinal Arterial Occlusion, Carbon Monoxide, Air Gas Embolism)\n* Contraindication to pseudoephedrine (monoamine oxidase inhibitors (MAOI) use, pregnancy, glaucoma, heart disease, allergy to drug class)\n* Systolic Blood Pressure \\>160\n* Diastolic Blood Pressure \\> 90\n* Heart Rate \\>100\n* Decongestant\u002Fantihistamine\u002Fpseudoephedrine\u002Fnasal steroid\u002Foxymetazoline use within 12 hours.\n* Prisoner\n* Intubated\n* Unable to swallow oral medications","ALL","18 Years",{"count":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this research is to study whether the use of pseudoephedrine can help prevent middle ear trauma during HBOT. Pseudoephedrine is an approved drug that is used for temporary relief of nasal or sinus pain and pressure.",[27],"Barotrauma",[29],"hyperbaric oxygen therapy","RECRUITING","2025-08-25",{"date":33,"type":34},"2025-08-27","ACTUAL",{"date":36,"type":34},"2023-01-31",{"date":38,"type":21},"2026-07",{"name":40,"class":41},"John Muir Health","OTHER",1,{"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":57,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100516217","laboratory-biomarkers-and-pulmonary-interstitial-emphysema-in-ards-pie-ards-100516217","NCT06001645","Laboratory Biomarkers and Pulmonary Interstitial Emphysema in ARDS (PIE-ARDS)","Pulmonary Interstitial Emphysema (Macklin Effect), Quantitative Imaging Analysis and CytoKine Profiling to Predict Lung Frailty IN ARDS","PIE-ARDS","Inclusion Criteria:\n\n* Clinical and radiological signs of ARDS, according to Berlin criteria, requiring ICU admission;\n* Obtain duly signed informed consent\n* Availability of at least one chest CT scan during hospital stay\n\nExclusion Criteria:\n\n• Poor quality imaging (because of motion\u002Frespiratory artefacts).",{"count":52,"type":21},110,"OBSERVATIONAL","Barotrauma (pneumothorax, pneumomediastinum) is a well-described complication of Acute Respiratory Distress Syndrome (ARDS), especially in patients with coronavirus disease 2019 (COVID-19) (16.1% in COVID-19, and about 6% in non-COVID-19 ARDS). Macklin effect was recently discovered by our group as an accurate radiological predictor of barotrauma in COVID-19 ARDS; the Investigators also found that density histograms automatically extracted from chest CT images provide a reliable insight into lung composition\n\n. Since lung frailty is a major issue also in non-COVID-19 ARDS, the Investigators want to confirm the predictive role of Macklin effect also in this setting. In addition, the Investigators aim to explore inflammatory profiling to decipher different biological aspects of the same clinical issue. Finally, the Investigators want to develop a specific management algorithm for patients diagnosed, according to our findings, with a specific ARDS sub phenotype characterized by increased lung frailty",[56,27],"Acute Respiratory Distress Syndrome",[56,58,59,60,61,62],"Mechanical Ventilation","Intensive Care","Respiratory Failure","Pneumothorax","Macklin effect","2025-08-06",{"date":65,"type":34},"2025-08-12",{"date":67,"type":34},"2023-11-27",{"date":69,"type":21},"2027-07",{"name":71,"class":41},"Università Vita-Salute San Raffaele",4,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},"100502030","imaging-biomarkers-to-stratify-the-risk-of-barotrauma-in-ards-100502030","NCT05816954","Imaging Biomarkers to Stratify the Risk of Barotrauma in ARDS","Artificial Intelligence-based Identification of Imaging Biomarkers of Lung FRAILty in Patients With Acute Respiratory Distress Syndrome.","FRAIL ARDS","Inclusion Criteria:\n\n* Clinical and radiological signs of ARDS, according to Berlin criteria \\[14\\], requiring ICU admission;\n* Obtain duly signed informed consent.\n\nExclusion Criteria:\n\n* Poor quality imaging (because of motion\u002Frespiratory artefacts).",{"count":82,"type":21},100,"The high incidence of barotrauma in patients with COVID-19-related acute respiratory distress syndrome (ARDS) (16.1%, with a mortality rate \\>60%) provides rationale for considering COVID-19 ARDS a paradigm for lung frailty. The investigators recently discovered that the Macklin effect is an impressive radiological predictor of barotrauma in COVID-19 ARDS. Since lung frailty is a major issue also in non-COVID-19 ARDS (6% barotrauma, with a mortality rate of 46% ) the investigators want to confirm the importance of Macklin effect in non-COVID-19 ARDS. Using artificial intelligence-based approaches the investigators also want to identify imaging biomarkers to non-invasively assess lung frailty in a mixed cohort of COVID-19\u002Fnon-COVID-19 ARDS patients. Furthermore, the investigators want to prospectively validate these biomarkers in a cohort of ARDS patients. This will provide a therapeutic algorithm for ARDS patients at high-risk for barotrauma, identifying those most likely to benefit from hyper protective strategies.",[56,27],"2025-08-05",{"date":63,"type":34},{"date":88,"type":34},"2023-08-30",{"date":90,"type":21},"2027-07-31",{"name":71,"class":41},2]