[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655303":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":34,"studyPopulation":25,"armGroups":35,"interventions":58,"overallOfficials":78,"centralContacts":82,"locations":88,"responsibleParty":105,"collaborators":25,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":25,"eligibilityCriteria":112,"healthyVolunteers":109,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":25,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":91,"whyStopped":25,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Research Inc","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Cabin-Class-by-Compression Interaction in Change in Popliteal Vein Diameter","Interaction term between prebooked cabin stratum and randomized stocking assignment for the change in participant-level mean bilateral popliteal vein diameter from preflight baseline to arrival.","Within 24 hours before departure and within 2 hours after arrival at the study site. 3 days",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Randomized Compression Stocking Effect on Arrival-Related Diameter Change","Adjusted mean difference between stocking and no-stocking assignments overall and separately within each cabin stratum.","Within 24 hours before departure and within 2 hours after arrival. 3 days",{"measure":19,"description":20,"timeFrame":17},"Adjusted Cabin-Class Association With Arrival-Related Diameter Change","Adjusted mean difference between premium and economy cabin groups overall and separately by stocking assignment. This contrast is observational because cabin class is not randomized.",{"measure":22,"description":23,"timeFrame":24},"Four-Group Popliteal Vein Diameter Trajectory","Estimated mean bilateral diameter and change from baseline in each of the four groups across postarrival time points.","Within 24 hours before departure; within 2 hours after arrival; 24 +\u002F- 2 hours; and 48 +\u002F- 2 hours after arrival. 3 days",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"NON_RANDOMIZED","PARALLEL","PREVENTION",{"masking":31,"maskingDescription":25,"whoMasked":32},"SINGLE",[33],"OUTCOMES_ASSESSOR","Participants will enter the study according to their prebooked cabin class and then be randomized within that stratum to wear properly fitted knee-high graduated compression stockings or no compression during the flight. The design creates four groups. Standardized bilateral ultrasound will quantify venous diameter and cross-sectional area before departure and through 48 hours after arrival, before surgery. Mixed-effects models will estimate the randomized stocking effect, the adjusted cabin-class association, and their interaction. The protocol will record seat characteristics, ambulation, hydration, adherence, symptoms, and safety events.",[36,44,49,54],{"label":37,"type":38,"description":39,"interventionNames":40},"Economy Cabin Plus Compression","EXPERIMENTAL","Participants with a prebooked economy itinerary randomized to knee-high moderate graduated compression stockings.",[41,42,43],"Device: Knee-High Graduated Compression Stockings","Other: Economy Cabin Exposure","Diagnostic Test: Standardized Bilateral Popliteal Vein Ultrasound",{"label":45,"type":46,"description":47,"interventionNames":48},"Economy Cabin Without Compression","ACTIVE_COMPARATOR","Participants with a prebooked economy itinerary randomized to no compression stockings.",[42,43],{"label":50,"type":38,"description":51,"interventionNames":52},"Premium Cabin Plus Compression","Participants with a prebooked business\u002Ffirst-class itinerary randomized to knee-high moderate graduated compression stockings.",[41,53,43],"Other: Premium Cabin Exposure",{"label":55,"type":46,"description":56,"interventionNames":57},"Premium Cabin Without Compression","Participants with a prebooked business\u002Ffirst-class itinerary randomized to no compression stockings.",[53,43],[59,64,69,73],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":25},"DEVICE","Knee-High Graduated Compression Stockings","PROPOSED pressure class: 20-30 mmHg at the ankle, properly fitted and worn from approximately 1 hour before boarding through the arrival ultrasound. Product and pressure class require confirmation. Linked arm\u002Fgroup(s): Economy Cabin Plus Compression, Premium Cabin Plus Compression.",[37,50],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":25},"OTHER","Economy Cabin Exposure","Prebooked and completed economy-cabin travel; seat characteristics and behavior are measured but not assigned. Linked arm\u002Fgroup(s): Economy Cabin Plus Compression, Economy Cabin Without Compression.",[37,45],{"type":65,"name":70,"description":71,"armGroupLabels":72,"otherNames":25},"Premium Cabin Exposure","Prebooked and completed business\u002Ffirst-class travel; seat characteristics and behavior are measured but not assigned. Linked arm\u002Fgroup(s): Premium Cabin Plus Compression, Premium Cabin Without Compression.",[50,55],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":25},"DIAGNOSTIC_TEST","Standardized Bilateral Popliteal Vein Ultrasound","Triplicate bilateral diameter and cross-sectional-area measurements before flight and at arrival, 24 hours, and 48 hours by an assessor masked to stocking allocation. Linked arm\u002Fgroup(s): Economy Cabin Plus Compression, Economy Cabin Without Compression, Premium Cabin Plus Compression, Premium Cabin Without Compression.",[37,45,50,55],[79],{"name":80,"affiliation":25,"role":81},"Hugo Aguilar","PRINCIPAL_INVESTIGATOR",[83],{"name":84,"role":85,"phone":86,"phoneExt":25,"email":87},"Hugo Aguilar, MD, Plastic surgeon","CONTACT","+57 301 6918526","havplasticacademy@gmail.com",[89],{"facility":90,"status":91,"city":92,"state":25,"zip":25,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"Clinica INO","RECRUITING","Bogotá","Colombia","CO",{"type":96,"coordinates":97},"Point",[98,99],-74.08175,4.60971,{"lat":99,"lon":98},[102],{"name":103,"role":85,"phone":104,"phoneExt":25,"email":87},"hugo Aguilar, MD, Plastic surgeon","+57 3016918526",{"type":106,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100655303","prospective-stratified-randomized-four-group-study-of-cabin-class-and-graduated-compression-stockings-on-popliteal-vein-dilation-after-long-haul-air-travel-after-aesthetic-surgery-100655303",false,"NCT07808931","Prospective Stratified Randomized Four-Group Study of Cabin Class and Graduated Compression Stockings on Popliteal Vein Dilation After Long-Haul Air Travel After Aesthetic Surgery","Inclusion Criteria:\n\n* Age 18 to 65 years.\n* Commercial itinerary to Bogota with at least 4 hours of total airborne time.\n* Prebooked premium business\u002Ffirst-class or economy-class cabin documented before randomization.\n* No medical requirement for or contraindication to graduated compression stockings.\n* Ability to complete standardized ultrasound before flight and through 48 hours after arrival before surgery.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Current deep venous thrombosis, therapeutic anticoagulation, or severe peripheral arterial disease.\n* Pregnancy.\n* Lower-extremity skin, neurologic, or anatomic condition preventing safe stocking use or ultrasound.\n* Cabin upgrade or downgrade after randomization that changes the prespecified stratum.\n* Surgery or major intravenous fluid therapy before the 48-hour examination.\n* Inability to follow the randomized stocking assignment.","ALL","18 Years","65 Years",{"count":117,"type":118},200,"ESTIMATED","INTERVENTIONAL",[121],"NA","This four-group prospective study will enroll travelers who have independently booked economy or premium business\u002Ffirst-class flights to Bogota. Within each cabin stratum, participants will be randomized to moderate graduated compression stockings or no stockings. Bilateral popliteal vein ultrasound will be performed before flight, within 2 hours after arrival, and at 24 and 48 hours. The primary outcome is the interaction between cabin class and compression assignment for change in mean bilateral popliteal vein diameter.",[124,125],"Physiologic Venous Dilation","Air Travel",[127,128,129,130,131,132],"Medical Tourism","Duplex Ultrasound","Popliteal Vein","Factorial Design","Compression Stockings","Cabin Class","2026-09-07",{"date":135,"type":136},"2026-09-09","ACTUAL",{"date":138,"type":136},"2024-01-12",{"date":140,"type":118},"2026-12-01",{"name":5,"class":6},1]