[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053942":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":29,"locations":35,"responsibleParty":50,"collaborators":28,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":28,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":28,"enrollmentInfo":61,"targetDuration":28,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":28,"overallStatus":38,"whyStopped":28,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"GE Healthcare","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Small Adult vs Adult Cuff (Upper Arm, Overlap Range 23-25 cm)","EXPERIMENTAL","Subjects with an upper-arm circumference within 23-25 cm, where both Small Adult (SA) and Adult (A) cuffs are suitable, are randomized in a 1:1 ratio to receive blood pressure measurements using either: -Small Adult cuff, or -Adult cuff Subjects with upper-arm circumferences in non-overlapping SA-only ranges are assigned the Small Adult cuff without randomization and are not included in this arm.",[13],"Device: NIBP Measurement",{"label":15,"type":10,"description":16,"interventionNames":17},"Adult vs Large Adult Cuff (Upper Arm, Overlap Range 31-33 cm)","Subjects with an upper-arm circumference within 31-33 cm, where both Adult (A) and Large Adult (LA) cuffs are suitable, are randomized in a 1:1 ratio to receive blood pressure measurements using either: Adult cuff, or Large Adult cuff Subjects with measurements in non-overlapping A-only or LA-only ranges are assigned the appropriate cuff without randomization and are not included in this arm.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Thigh Cuff (Fallback\u002FNon-Randomized)","Subjects whose arm circumference is either: -Outside the allowable upper-arm range (17-40 cm), or -Eligible but excluded due to fulfillment of upper-arm cuff quotas will undergo thigh circumference measurement. Those with a thigh circumference within 38-50 cm will receive blood pressure measurements using a thigh cuff. Subjects outside the thigh circumference range are excluded prior to any blood pressure measurements.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","NIBP Measurement","The collection of non-invasive blood pressure measurements using NIBP Standard Parameter Module with SuperSTAT algorithm with simultaneous invasive blood pressure waveform recordings per discretion of the sponsor upon combining the data from other clinical studies to comply with ISO 81060-2:2018 +AMD2:2024.",[15,9,19],null,[30],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Pasi Karjalainen","CONTACT","+ 358 40 5480853","pasi.karjalainen@hus.fi",[36],{"facility":37,"status":38,"city":39,"state":28,"zip":28,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Tower Hospital, the Heart and Lung Center","RECRUITING","Helsinki","Finland","FI",{"type":43,"coordinates":44},"Point",[45,46],24.93545,60.16952,{"lat":46,"lon":45},[49],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},{"type":51,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100053942","nibp-accuracy-study-for-adult-subject-populations-100053942",false,"NCT07697950","NIBP Accuracy Study for Adult Subject Populations","Non-Invasive Blood Pressure Accuracy Study for Adult Subject Populations","Inclusion Criteria:\n\n1. Age requirement: 18 and over.\n2. Have an upper limb (right OR left side) that fits the cuff size of the device (circumference ranging 17 cm to 40 cm) OR have a thigh (right OR left side) that fits a cuff size of the device (circumference ranging 38 to 50 cm).\n3. Have an arterial line as a standard of care, which measures blood pressure at the aortic root.\n4. Able to provide written informed consent.\n5. Expected to remain in the unit for the duration of the study procedure.\n\nExclusion Criteria:\n\n1. Have previously participated in this study (no subject may participate more than once).\n2. Pregnant and lactating women per site standard of care.\n3. Subjects with peripheral arterial diseases (causing left\u002Fright arm difference)\n4. Hemodynamically unstable subjects at the discretion of the investigator.\n5. Exhibited injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the Investigator, may prevent proper cuff application or functioning.\n6. Are suffering from infection(s) or immunocompromised patients that require isolation.\n7. PI or designee decision due to subject health conditions","ALL","18 Years",{"count":62,"type":63},130,"ESTIMATED","INTERVENTIONAL",[66],"NA","The purpose of this study is to collect NIBP and invasive aortic pressure data from the clinical setting.",[69,70],"Blood Pressure Measurement","Blood Pressure","2026-07-07",{"date":73,"type":74},"2026-07-13","ACTUAL",{"date":76,"type":74},"2025-01-13",{"date":78,"type":63},"2027-12-31",{"name":5,"class":6},1]