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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
160
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.
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.
Clinica INO
Bogotá, Colombia
RECRUITINGDifference in Change in Mean Bilateral Popliteal Vein Diameter
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.
Time frame: Within 24 hours before departure and within 2 hours after arrival at the study site. 2 days
Incidence of Stocking-Related Adverse Effects
Proportion with skin injury, numbness, clinically significant pain, intolerance, or early removal attributed to the stocking.
Time frame: From stocking application through 24 hours after arrival. 5 days
Incidental Venous Thrombosis or Abnormal Compressibility
Number and proportion with an ultrasound abnormality requiring urgent clinical assessment.
Time frame: From preflight baseline through 48 hours after arrival - 1 week
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