NCT07810179

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jan 2024Dec 2026

Study Start

First participant enrolled

January 12, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

2.6 years

First QC Date

September 2, 2026

Last Update Submit

September 2, 2026

Conditions

Keywords

Cabin ClassBusiness ClassFirst ClassEconomy ClassPopliteal VeinDuplex UltrasoundMedical Tourism

Outcome Measures

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.

    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

    From preflight baseline through 48 hours after arrival. 3 days

Study Arms (2)

Premium Cabin Travelers

Participants who independently booked and completed the qualifying itinerary in business or first class.

Other: Premium Cabin Air Travel ExposureDiagnostic Test: Standardized Bilateral Popliteal Vein Ultrasound

Economy Cabin Travelers

Participants who independently booked and completed the qualifying itinerary in economy or basic economy class.

Other: Economy Cabin Air Travel ExposureDiagnostic Test: Standardized Bilateral Popliteal Vein Ultrasound

Interventions

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.

Premium Cabin Travelers

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

Economy Cabin Travelers

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.

Economy Cabin TravelersPremium Cabin Travelers

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.
  • Arrival, 24-hour, and 48-hour ultrasound completed before surgery.
  • Written informed consent.

You may not qualify if:

  • 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.
  • Surgery, prolonged immobilization, or major intravenous fluid administration before completion of the 48-hour scan.
  • Use of cabin upgrade after baseline or inability to verify the actual cabin flown.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica INO

Bogotá, Colombia

RECRUITING

Related Publications (2)

  • Ramirez B, Aguilar H, Stanford N, Paez Z, Menendez JP, Pachon J, Osorio E, Varela A. Aesthetic Surgical Tourism: Physiological Changes During Flight That May Affect Patient Safety and Outcomes. Plast Reconstr Surg Glob Open. 2026 May 8;14(5):e7568. doi: 10.1097/GOX.0000000000007568. eCollection 2026 May.

    PMID: 42110381BACKGROUND
  • Hoyos AE, Ramirez B, Benavides J, Perez Pachon ME, Varela A. Aeromedical Considerations for Patient Safety in Aesthetic Medical Tourism. Aerosp Med Hum Perform. 2024 Oct;95(10):765-770. doi: 10.3357/AMHP.6432.2024.

    PMID: 39431700BACKGROUND

Study Officials

  • Hugo Aguilar

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hugo Aguilar, MD, Plastic surgeon

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2026

First Posted

September 9, 2026

Study Start

January 12, 2024

Primary Completion

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 9, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

not contempled in the patient informed consent

Locations