Air Travel, Physiologic Venous Dilation
Conditions
Keywords
Medical Tourism, Duplex Ultrasound, Popliteal Vein, Factorial Design, Compression Stockings, Cabin Class
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.
Detailed description
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.
Interventions
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.
OTHEREconomy Cabin Exposure
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.
OTHERPremium Cabin Exposure
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.
DIAGNOSTIC_TESTStandardized 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/group(s): Economy Cabin Plus Compression, Economy Cabin Without Compression, Premium Cabin Plus Compression, Premium Cabin Without Compression.
Sponsors
Research Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cabin-Class-by-Compression Interaction in Change in Popliteal Vein Diameter | Within 24 hours before departure and within 2 hours after arrival at the study site. 3 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Randomized Compression Stocking Effect on Arrival-Related Diameter Change | Within 24 hours before departure and within 2 hours after arrival. 3 days | Adjusted mean difference between stocking and no-stocking assignments overall and separately within each cabin stratum. |
| Adjusted Cabin-Class Association With Arrival-Related Diameter Change | Within 24 hours before departure and within 2 hours after arrival. 3 days | 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. |
| 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 | Estimated mean bilateral diameter and change from baseline in each of the four groups across postarrival time points. |
Countries
Colombia
Contacts
CONTACTHugo Aguilar, MD, Plastic surgeon
PRINCIPAL_INVESTIGATORHugo Aguilar
Outcome results
None listed