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
1 other identifier
interventional
200
1 country
1
Brief Summary
This four-group prospective study will enroll travelers who have independently booked economy or premium business/first-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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
CompletedFirst Submitted
Initial submission to the registry
September 2, 2026
CompletedFirst Posted
Study publicly available on registry
September 9, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedSeptember 9, 2026
September 1, 2026
2.6 years
September 2, 2026
September 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Randomized Compression Stocking Effect on Arrival-Related Diameter Change
Within 24 hours before departure and within 2 hours after arrival. 3 days
Adjusted Cabin-Class Association With Arrival-Related Diameter Change
Within 24 hours before departure and within 2 hours after arrival. 3 days
Four-Group Popliteal Vein Diameter Trajectory
Within 24 hours before departure; within 2 hours after arrival; 24 +/- 2 hours; and 48 +/- 2 hours after arrival. 3 days
Study Arms (4)
Economy Cabin Plus Compression
EXPERIMENTALParticipants with a prebooked economy itinerary randomized to knee-high moderate graduated compression stockings.
Economy Cabin Without Compression
ACTIVE COMPARATORParticipants with a prebooked economy itinerary randomized to no compression stockings.
Premium Cabin Plus Compression
EXPERIMENTALParticipants with a prebooked business/first-class itinerary randomized to knee-high moderate graduated compression stockings.
Premium Cabin Without Compression
ACTIVE COMPARATORParticipants with a prebooked business/first-class itinerary randomized to no compression stockings.
Interventions
Prebooked and completed economy-cabin travel; seat characteristics and behavior are measured but not assigned. Linked arm/group(s): Economy Cabin Plus Compression, Economy Cabin Without Compression.
Prebooked and completed business/first-class travel; seat characteristics and behavior are measured but not assigned. Linked arm/group(s): Premium Cabin Plus Compression, Premium Cabin Without Compression.
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/group(s): Economy Cabin Plus Compression, Economy Cabin Without Compression, Premium Cabin Plus Compression, Premium Cabin Without Compression.
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/group(s): Economy Cabin Plus Compression, Premium Cabin Plus Compression.
Eligibility Criteria
You may qualify if:
- Age 18 to 65 years.
- Commercial itinerary to Bogota with at least 4 hours of total airborne time.
- Prebooked premium business/first-class or economy-class cabin documented before randomization.
- No medical requirement for or contraindication to graduated compression stockings.
- Ability to complete standardized ultrasound before flight and through 48 hours after arrival before surgery.
- Written informed consent.
You may not qualify if:
- Current deep venous thrombosis, therapeutic anticoagulation, or severe peripheral arterial disease.
- Pregnancy.
- Lower-extremity skin, neurologic, or anatomic condition preventing safe stocking use or ultrasound.
- Cabin upgrade or downgrade after randomization that changes the prespecified stratum.
- Surgery or major intravenous fluid therapy before the 48-hour examination.
- Inability to follow the randomized stocking assignment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Research Inclead
Study Sites (1)
Clinica INO
Bogotá, Colombia
Study Officials
- PRINCIPAL INVESTIGATOR
Hugo Aguilar
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2026
First Posted
September 9, 2026
Study Start
January 12, 2024
Primary Completion
September 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
September 9, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share
not contempled in the patient informed concent