Prospective Comparative Cohort Study of Premium Versus Economy Cabin Travel and Popliteal Vein Diameter After Long-Haul Flight After an Aesthetic Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorResearch Inc

About this trial

This prospective cohort study will compare popliteal vein diameter changes in international travelers who independently fly to Bogota in premium business/first class or economy class. Standardized bilateral ultrasound will be performed before flight, within 2 hours after arrival, and at 24 and 48 hours. The primary outcome is the adjusted between-group difference in change from preflight diameter to arrival. Travel behavior and venous-risk confounders will be measured prospectively.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 65 years.

Commercial flight to Bogota with at least 4 hours of total airborne time.

Prebooked premium business/first-class or economy-class seat documented before enrollment.

Standardized preflight ultrasound within 24 hours before departure.

Disqualifiers

Current or prior unprovoked deep venous thrombosis requiring therapeutic anticoagulation.

Therapeutic anticoagulation during the study window.

Current pregnancy.

Lower-extremity condition preventing standardized bilateral popliteal ultrasound.

Trial population

Adult international medical travelers with prebooked premium business/first-class or economy-class itineraries of at least 4 hours.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Premium Cabin Air Travel Exposure

    Other intervention

    Preexisting travel exposure defined by the cabin actually flown. Seat pitch, recline, lie-flat capability, aisle/window position, and ambulation opportunities will be recorded. Linked arm/group(s): Premium Cabin Travelers.

  • Economy Cabin Air Travel Exposure

    Other intervention

    Preexisting economy-cabin exposure with documentation of seat characteristics, position, movement, hydration, and other travel behaviors. Linked arm/group(s): Economy Cabin Travelers.

  • Standardized Bilateral Popliteal Vein Ultrasound

    Diagnostic test

    Triplicate anteroposterior and transverse diameter and cross-sectional-area measurements in both legs after a standardized resting period, with compressibility and flow assessment. Linked arm/group(s): Premium Cabin Travelers, Economy Cabin Travelers.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Premium Cabin Travelers2 interventions
Group B: Economy Cabin Travelers2 interventions

Trial outcomes

Primary outcomes

1

Between-Cabin Difference in Change in Mean Bilateral Popliteal Vein Diameter

Difference between premium and economy groups in the participant-level change from preflight baseline to arrival. Diameter will be the mean of triplicate anteroposterior measurements in both legs and will be reported in millimeters.

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

Secondary outcomes

1

Incidental Venous Thrombosis or Abnormal Compressibility

Number and proportion with a new abnormality requiring immediate clinical assessment.

Time frame
From preflight baseline through 48 hours after arrival. 3 days

Other outcomes

Sponsors and contacts

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