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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorResearch Inc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Knee-High Graduated Compression Stockings

    Device

    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.

  • Economy Cabin Exposure

    Other intervention

    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.

  • Premium Cabin Exposure

    Other intervention

    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.

  • Standardized Bilateral Popliteal Vein Ultrasound

    Diagnostic test

    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.

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: Economy Cabin Plus CompressionExperimental treatment 3 interventions
Group B: Economy Cabin Without CompressionActive comparator 2 interventions
Group C: Premium Cabin Plus CompressionExperimental treatment 3 interventions
Group D: Premium Cabin Without CompressionActive comparator 2 interventions

Trial outcomes

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.

Time frame
Within 24 hours before departure and within 2 hours after arrival at the study site. 3 days

Secondary outcomes

1

Randomized Compression Stocking Effect on Arrival-Related Diameter Change

Adjusted mean difference between stocking and no-stocking assignments overall and separately within each cabin stratum.

Time frame
Within 24 hours before departure and within 2 hours after arrival. 3 days
2

Adjusted Cabin-Class Association With Arrival-Related Diameter Change

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.

Time frame
Within 24 hours before departure and within 2 hours after arrival. 3 days
3

Four-Group Popliteal Vein Diameter Trajectory

Estimated mean bilateral diameter and change from baseline in each of the four groups across postarrival time points.

Time frame
Within 24 hours before departure; within 2 hours after arrival; 24 +/- 2 hours; and 48 +/- 2 hours after arrival. 3 days

Other outcomes

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