- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07808411
Prospective Repeated-Measures Study of Popliteal Vein Diameter During the First 48 Hours After Commercial Air Travel to Bogota for a Plastic Surgery Intervention
September 2, 2026 updated by: Research Inc
This prospective repeated-measures study will evaluate how long popliteal vein dilation persists after international commercial air travel to Bogota.
Adult medical travelers will undergo standardized bilateral popliteal vein ultrasound within 24 hours before departure, within 2 hours after arrival, and at 24 and 48 hours after arrival, all before surgery.
The primary outcome is change in mean bilateral popliteal vein diameter over time.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Eligible international travelers will complete a standardized preflight ultrasound and three postarrival examinations before surgery or intravenous fluid therapy.
Each scan will be performed after a fixed resting period using the same popliteal landmark, minimal transducer pressure, and triplicate bilateral measurements.
Flight duration, class, seat characteristics, movement, fluid intake, compression stocking use, and venous risk factors will be recorded.
Mixed-effects analysis will estimate the postflight diameter and cross-sectional-area trajectory and the proportion returning to within 10% of baseline by 48 hours.
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: hugo Aguilar, MD, Plastic surgeon
- Phone Number: +57 301 6918526
- Email: havplasticacademy@gmail.com
Study Locations
-
-
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Bogotá, Colombia
- Recruiting
- Clinica INO
-
Contact:
- hugo Aguilar, MD, Plastic surgeon
- Phone Number: +57 3016918526
- Email: havplasticacademy@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult international medical travelers completing a commercial flight of at least 4 hours to Bogota and undergoing all ultrasound measurements before surgery.
Description
Inclusion Criteria:
- Age 18 to 65 years.
- International commercial flight to Bogota with total airborne time of at least 4 hours.
- Preflight baseline ultrasound obtained within 24 hours before departure using the standardized protocol.
- Arrival ultrasound completed within 2 hours after reaching the study site and before surgery or intravenous fluid therapy.
- Availability for 24-hour and 48-hour examinations.
- Written informed consent.
Exclusion Criteria:
- Known current deep venous thrombosis or pulmonary embolism.
- Therapeutic anticoagulation at enrollment.
- Major lower-extremity venous surgery, active leg infection, or condition preventing popliteal ultrasound.
- Surgery, prolonged immobilization, or substantial intravenous fluid administration before completion of the 48-hour measurement.
- Pregnancy.
- Nondiagnostic baseline examination or inability to reproduce the landmark.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Postflight Repeated-Measures Cohort
All participants undergo standardized preflight and postarrival bilateral popliteal vein ultrasound without assignment to a travel intervention.
|
Participants complete a commercial flight of at least 4 hours to Bogota.
Flight duration, connections, cabin class, seat characteristics, movement, fluid intake, alcohol, sedatives, and compression stocking use will be recorded.
Linked arm/group(s): Postflight Repeated-Measures Cohort.
After at least 10 minutes of supine rest, the popliteal vein will be imaged at a fixed landmark with minimal probe pressure.
Anteroposterior and transverse diameters, cross-sectional area, compressibility, and flow will be recorded in both legs, with three repeated measurements averaged.
Linked arm/group(s): Postflight Repeated-Measures Cohort.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Mean Bilateral Popliteal Vein Diameter
Time Frame: Within 24 hours before departure; within 2 hours after arrival at the study site; 24 +/- 2 hours after arrival; and 48 +/- 2 hours after arrival. 1 week
|
At each visit, the mean of three anteroposterior diameter measurements in each leg will be calculated, followed by the mean of both legs.
Change from the participant's preflight value will be reported in millimeters and as percent change.
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Within 24 hours before departure; within 2 hours after arrival at the study site; 24 +/- 2 hours after arrival; and 48 +/- 2 hours after arrival. 1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Return of Popliteal Vein Diameter to Baseline
Time Frame: 24 +/- 2 hours and 48 +/- 2 hours after arrival. 1 week
|
Proportion of participants whose mean bilateral diameter is within plus or minus 10% of their preflight value.
|
24 +/- 2 hours and 48 +/- 2 hours after arrival. 1 week
|
|
Incidental Venous Thrombosis or Abnormal Compressibility
Time Frame: From preflight baseline through 48 hours after arrival. 1week
|
Number and proportion of participants with a new noncompressible venous segment or other finding requiring diagnostic clinical evaluation.
This research protocol is not designed as a definitive thrombosis screening examination unless the final duplex protocol is expanded.
|
From preflight baseline through 48 hours after arrival. 1week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hugo Aguilar, MD, plastic surgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 12, 2024
Primary Completion (Actual)
September 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
September 2, 2026
First Submitted That Met QC Criteria
September 2, 2026
First Posted (Actual)
September 8, 2026
Study Record Updates
Last Update Posted (Actual)
September 8, 2026
Last Update Submitted That Met QC Criteria
September 2, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 015 (Other Identifier: Nahrain Medical Research Collective (NMRC))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
not contempled in the patient informed consent
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.