Health Trials

Randomized Assessor-Masked Trial of Moderate Graduated Compression Stockings for Popliteal Vein Dilation During Long-Haul Economy-Class Air Travel After Aesthetic Surgery

ConditionsPhysiologic Venous DilationAir Travel
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorResearch Inc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Enoxaparine

    Drug

    All patients got enoxaparin to prevent blood clots

  • Knee-High Graduated Compression Stockings

    Device

    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.

  • Standardized Bilateral Popliteal Vein Ultrasound

    Diagnostic test

    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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Moderate Compression StockingsExperimental treatment 3 interventions
Group B: No Compression StockingsActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Difference 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

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

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Research Inc

Lead sponsor

Source ClinicalTrials.gov
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