[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557458":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":29,"locations":38,"responsibleParty":60,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":20,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":20,"enrollmentInfo":76,"targetDuration":20,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":20,"overallStatus":40,"whyStopped":20,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Portable Dynamic Digital Radiography (DDR) + Clinical Gold Standard Imaging","EXPERIMENTAL","Dynamic digital radiography (DDR) is a new version of chest radiography from Konica Minolta (KM) that provides more advanced measures of lung motion, ventilation, and perfusion compared to traditional chest radiography. DDR scans are dynamic images that have a rate of 15 frames per second (for 7-20 seconds), acting as a mini-fluorography machine with radiation that is only slightly greater than a traditional chest x-ray.\n\nEvery patient will receive both a DDR scan and a gold standard scan. Each patient's DDR images will be compared to the golden standard that is completed as part of the patient's routine standard of care. For instance, for many ICU patients this includes traditional chest x-rays, ultrasounds or VQ scans.",[13],"Diagnostic Test: Portable Dynamic Digital Radiography (DDR)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","Portable Dynamic Digital Radiography (DDR)","(DDR imaging has already been described in the arm\u002Fgroup description). Each patient in the study will receive at least one set of DDR images, which consists of one 7-second scan in which the patient breaths normally, and a second 7-second scan in which the patient holds their breath (or for ventilated patients, an inspiratory pause is placed by the care team).\n\nIf the patient's conditions warrant it, up to two sets of follow-up scans may be acquired. For instance, in a patient with diaphragmatic dysfunction, imaging may be completed pre- and post- diaphragmatic plication.",[9],null,[22,25,27],{"name":23,"affiliation":5,"role":24},"Gyorgy Frendl, MD PhD","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":5,"role":24},"Hiroto Hatabu, MD PhD",{"name":28,"affiliation":5,"role":24},"Bruno Madore, PhD",[30,34],{"name":23,"role":31,"phone":32,"phoneExt":20,"email":33},"CONTACT","617-732-5910","gfrendl@bwh.harvard.edu",{"name":35,"role":31,"phone":36,"phoneExt":20,"email":37},"Poorva Bagchee, BS","585-203-2857","pbagchee@bwh.harvard.edu",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-71.05977,42.35843,{"lat":50,"lon":49},[53,56,57,59],{"name":54,"role":31,"phone":55,"phoneExt":20,"email":33},"Gyorgy Frendl, MD, PhD","6177325910",{"name":54,"role":24,"phone":20,"phoneExt":20,"email":20},{"name":58,"role":24,"phone":20,"phoneExt":20,"email":20},"Hiroto Hatabu, MD, PhD",{"name":28,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":24,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Gyorgy Frendl, M.D., Ph.D.","Principal Investigator",[64],{"name":65,"class":66},"Konica Minolta","UNKNOWN","100557458","clinical-utility-of-portable-dynamic-chest-x-ray-ddr-in-the-icu-100557458",false,"NCT06538376","Clinical Utility of Portable Dynamic Chest X Ray (DDR) in the ICU","Clinical Utility of Portable Dynamic Chest X-Ray (DDR) in the ICU: Clinical Trial to Demonstrate the Feasibility of Deploying DDR Technology in the ICU - A Study to Prove Its Increased Diagnostic Value","Inclusion Criteria: Participants must meet all the following inclusion criteria to participate in this study:\n\n* Adults (at least 18 years of age) including both intubated\u002Fventilated and non-intubated patients\n* Likely to have pathology related to either, abnormal diaphragmatic excursion and lung aeration, pulmonary perfusion, increased lung water content or all the above, as well as for cricopharyngeal dysfunction\u002Fswallowing difficulties at risk for aspiration.\n* The subject or a legally authorized representative has provided written informed consent.\n\nExclusion Criteria: Candidates meeting any of the exclusion criteria at baseline will be excluded from study participation. These criteria are:\n\n* Special populations, including women with known pregnancy, prisoners, or institutionalized individuals\n* Patients where additional radiation is clinically contraindicated\n* Care team does not provide assent for approaching patient\u002Fsurrogate\n* For women of child-bearing potential, defined as premenopausal women, a pregnancy test will be administered to determine pregnancy status and confirm eligibility for the study. A pregnancy test will NOT be administered to women who are post-menopausal or have documentation of surgical sterilization.","ALL","18 Years",{"count":77,"type":78},230,"ESTIMATED","INTERVENTIONAL",[81],"NA","Dynamic digital radiography (DDR) is a new advanced version of chest radiography that captures dynamic images at a rate of 15 frames per second. It is coupled with an analytical software that allows it to provide more advanced measures of lung motion, ventilation, and perfusion compared to traditional chest radiography. While implementation of DDR fixed machines are beginning elsewhere in the US, this trial involves the first applications of an FDA-approved portable DDR machine, for use at the bedside in the ICU.\n\nThe goal of this clinical trial is to determine the feasibility and safety of portable DDR technology in the ICU, as well as to evaluate the improved clinical diagnostic value of the portable DDR system over current standards of care.\n\nParticipants will receive one to three sets of DDR images, which will then be compared to their clinical gold standard exams (such as chest x-rays, CTs, or VQ scans) to assess and improve the precision and accuracy of measurements such as diaphragmatic motion, lung movement, and perfusion.",[84,85,86,87,88,89,90,91,92,93,94,95,96,97],"Pulmonary Edema","Pneumonia","Atelectasis","Pleural Effusion","Acute Rejection of Lung Transplant (Disorder)","Airway Obstruction","Rib Fractures","Acute Copd Exacerbation","Asthma COPD","Pulmonary Embolism","Hemothorax","Pneumothorax","Mesothelioma","Diaphragmatic Paralysis","2025-10-28",{"date":100,"type":101},"2025-10-29","ACTUAL",{"date":103,"type":101},"2023-12-12",{"date":105,"type":78},"2027-11",{"name":5,"class":6},1]