[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07722065":3,"trial-entities:NCT07722065":77,"trial-summary:NCT07722065":81},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":39,"secondary_outcomes":44,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":15,"eligibility_criteria":51,"std_ages":58,"locations":60,"central_contacts":70,"overall_officials":71,"references":75,"see_also_links":76},"NCT07722065","STUDY00001776","Handheld US Device to Verify Vascular Cannulation","The Use of a Handheld Cardiac Ultrasound Device to Verify Successful Peripheral Vascular Cannulation in Pediatric Patients.","ENROLLING_BY_INVITATION","2027-12","2026-07","2026-07-23","2026-08","Alok Moharir","OTHER",false,"This a prospective study in pediatric patients undergoing surgery and requiring placement of an intravenous cannula. This will be a novel study to assess whether a handheld compatible cardiac ultrasound device (Lumify) can be used to quickly and reliably verify successful vascular cannulation in pediatric patients using the rapid atrial swirl sign (RASS) technique. As emerging technologies have made hand-held ultrasound devices more versatile, portable, and cheaper, it will be important to prove if they can be as accurate as traditional ultrasound devices for their intended focused point-of-care functions. If the handheld device is deemed efficacious, it will allow the use of a portable hand-held device rather than the more difficult to transport devices (Sonosite).",null,[19],"Surgery",[],"INTERVENTIONAL","DIAGNOSTIC",[24],"NA",{"count":26,"type":27},100,"ESTIMATED",[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","Sonosite","A stand alone ultrasound machine with a linear probe.",[31],{"type":30,"name":35,"description":36,"armGroupLabels":37},"Lumify®","A novel, handheld ultrasound device with a cardiac phase array probe attached to a tablet.",[38],"Lumify",[40],{"measure":41,"description":42,"timeFrame":43},"RASS","The ability of a hand held cardiac ultrasound in detecting successful peripheral IV placement using the right atrial swirl sign (RASS) compared to a traditional ultrasound.","Baseline",[45],{"measure":46,"description":47,"timeFrame":43},"Time","The amount of time required to obtain the necessary imaging between the two devices.","ALL","1 Year","6 Years",{"inclusion":52,"exclusion":55,"raw_text":57},[53,54],"pediatric patients ranging in age from 1-6 years","presenting for surgery and requiring placement of an intravenous cannula.",[56],"potential subjects that are fluid or sodium sensitive","Inclusion Criteria:\n\n* pediatric patients ranging in age from 1-6 years\n* presenting for surgery and requiring placement of an intravenous cannula.\n\nExclusion Criteria:\n\n* potential subjects that are fluid or sodium sensitive",[59],"CHILD",[61],{"facility":62,"city":63,"state":64,"zip":65,"country":66,"geoPoint":67},"Nationwide Children's Hospital","Columbus","Ohio","43205","United States",{"lat":68,"lon":69},39.96118,-82.99879,[],[72],{"name":73,"affiliation":62,"role":74},"Alok Moharir, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":78,"biomarkers":80},[79],"Surgical Procedure",[],{"nct_id":4,"found":82,"summary":83,"prompt_version":93},true,{"design":84,"status":85,"heading":86,"summary":87,"follow_up":88,"word_count":89,"commitments":90,"compensation":91,"drugs_mentioned":92},"This is an interventional study involving 100 pediatric patients. It compares a handheld ultrasound device (Lumify®) to a standard ultrasound machine (Sonosite).","completed","Handheld Ultrasound for Vascular Cannulation in Children","This study is looking at a new way to check if an IV (intravenous) line is correctly placed in children aged 1 to 6 years old who are having surgery. Researchers are comparing a traditional ultrasound machine (Sonosite) with a new, portable handheld ultrasound device called Lumify®. The goal is to see if Lumify® can quickly and accurately confirm that the IV is in the right place using a technique called the rapid atrial swirl sign (RASS). This could make it easier to use ultrasound in more places. You might be able to join if your child is between 1 and 6 years old, needs an IV for surgery, and is not sensitive to fluids or sodium. The study aims to enroll 100 children, but the current recruitment status is unclear.","The primary endpoint, RASS, is measured at Baseline, suggesting follow-up beyond this point is not specified.",131,"Not specified in the trial record.","Not stated in the trial record.",[31,35],"v2"]