Air Travel, Physiologic Venous Dilation
Conditions
Keywords
Compression Stockings, Air Travel, Popliteal Vein, Duplex Ultrasound, Medical Tourism
Brief summary
This randomized assessor-masked trial will evaluate whether knee-high moderate graduated compression stockings reduce popliteal vein dilation during long-haul economy-class air travel to Bogota. Participants will be assigned to stockings or no stockings and will undergo bilateral ultrasound before flight, within 2 hours after arrival, and at 24 and 48 hours. The primary outcome is the between-group difference in change in mean bilateral popliteal vein diameter from preflight baseline to arrival.
Detailed description
Eligible economy-class travelers will be randomized before departure. The intervention group will wear properly fitted knee-high graduated compression stockings from approximately 1 hour before boarding through the arrival ultrasound; the control group will not use lower-limb compression. A masked ultrasound assessor will obtain standardized bilateral diameter and cross-sectional-area measurements before flight and at arrival, 24 hours, and 48 hours. Adherence, movement, hydration, symptoms, and skin effects will be recorded. Intention-to-treat mixed models will estimate immediate and persistent treatment effects.
Interventions
DRUGEnoxaparine
All patients got enoxaparin to prevent blood clots
PROPOSED pressure class: 20-30 mmHg at the ankle, appropriately sized according to calf and ankle circumference, worn from approximately 1 hour before boarding until completion of the arrival ultrasound. The final product, pressure class, fitting method, and wear instructions must be confirmed. Linked arm/group(s): Moderate Compression Stockings.
DIAGNOSTIC_TESTStandardized Bilateral Popliteal Vein Ultrasound
Triplicate bilateral diameter and cross-sectional-area measurements after a standardized rest period, with compressibility and flow assessment by an assessor masked to allocation. Linked arm/group(s): Moderate Compression Stockings, No Compression Stockings.
Sponsors
Research Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 65 years. * Economy-class commercial itinerary to Bogota with at least 4 hours of total airborne time. * No clinical indication that mandates or prohibits compression stockings. * Ability to obtain the assigned stocking before boarding and wear it as instructed. * Standardized preflight and postarrival ultrasounds completed before surgery. * Written informed consent.
Exclusion criteria
* Current deep venous thrombosis, therapeutic anticoagulation, or severe peripheral arterial disease. * Significant lower-limb skin disease, ulceration, neuropathy, or deformity preventing safe stocking use. * Pregnancy. * Planned use of another compression device during the flight. * Surgery or major intravenous fluid therapy before completion of the 48-hour examination. * Inability to complete preflight ultrasound or follow assigned treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Change in Mean Bilateral Popliteal Vein Diameter | Within 24 hours before departure and within 2 hours after arrival at the study site. 2 days | Between-group difference in baseline-to-arrival change in the mean of triplicate anteroposterior diameter measurements from both legs, reported in millimeters and percent change. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Stocking-Related Adverse Effects | From stocking application through 24 hours after arrival. 5 days | Proportion with skin injury, numbness, clinically significant pain, intolerance, or early removal attributed to the stocking. |
| Incidental Venous Thrombosis or Abnormal Compressibility | From preflight baseline through 48 hours after arrival - 1 week | Number and proportion with an ultrasound abnormality requiring urgent clinical assessment. |
Countries
Colombia
Contacts
CONTACTHugo Aguilar, MD, Plastic surgeon
PRINCIPAL_INVESTIGATORHugo Aguilar
Outcome results
None listed