Physiologic Venous DilationNCT07808411
Prospective Repeated-Measures Study of Popliteal Vein Diameter During the First 48 Hours After Commercial Air Travel to Bogota for a Plastic Surgery Intervention
An observational study of Physiologic Venous Dilation and Air Travel, run by Research Inc at 1 site in Colombia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Physiologic Venous Dilation, Air Travel
- What is being tested?
- Commercial Air Travel Exposure and Standardized Bilateral Popliteal Vein Duplex Ultrasound
- How many people
- 100 participants
- Where
- 1 siteColombia
- Study dates
- 12 Jan 2024to 1 Dec 2026
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult international medical travelers completing a commercial flight of at least 4 hours to Bogota and undergoing all ultrasound measurements before surgery.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Clinica INO
Bogotá
hugo Aguilar, MD, Plastic surgeon, +57 3016918526, havplasticacademy@gmail.com
About this study
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.
Read the 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.
- Conditions
- Physiologic Venous Dilation, Air Travel
- Being tested
- Commercial Air Travel Exposure, Standardized Bilateral Popliteal Vein Duplex Ultrasound
- Keywords
- Popliteal Vein, Air Travel, Medical Tourism, Venous Diameter, Duplex Ultrasound, Long-Haul Flight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercial Air Travel ExposureOther
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.
Standardized Bilateral Popliteal Vein Duplex UltrasoundDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Postflight Repeated-Measures Cohort | All participants undergo standardized preflight and postarrival bilateral popliteal vein ultrasound without assignment to a travel intervention. Receives: Other: Commercial Air Travel Exposure; Diagnostic Test: Standardized Bilateral Popliteal Vein Duplex Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Bilateral Popliteal Vein Diameter
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.
Measured: 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 outcomes (2)
Return of Popliteal Vein Diameter to Baseline
Proportion of participants whose mean bilateral diameter is within plus or minus 10% of their preflight value.
Measured: 24 +/- 2 hours and 48 +/- 2 hours after arrival. 1 week
Incidental Venous Thrombosis or Abnormal Compressibility
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.
Measured: From preflight baseline through 48 hours after arrival. 1week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start12 Jan 2024
- Primary completion1 Sep 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physiologic Venous DilationStudies of the same condition, open and under way.
- More trials run by Research IncThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hugo Aguilar, MD, plastic surgery, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808411
- Sponsor's protocol ID
- 015
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not contempled in the patient informed consent
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.
PubMed 39431700Ramirez 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.
PubMed 42110381
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Repeated-Measures Study of Popliteal Vein Diameter During the First 48 Hours After Commercial Air Travel to Bogota for a Plastic Surgery Intervention
- ClinicalTrials.gov ID
- NCT07808411
- Acronym / sponsor ID
- 015
- Conditions
- Physiologic Venous Dilation, Air Travel
- Keywords
- Popliteal Vein, Air Travel, Medical Tourism, Venous Diameter, Duplex Ultrasound, Long-Haul Flight
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Research IncIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postflight Repeated-Measures Cohort | – | Other: Commercial Air Travel Exposure, Diagnostic Test: Standardized Bilateral Popliteal Vein Duplex UltrasoundAll participants undergo standardized preflight and postarrival bilateral popliteal vein ultrasound without assignment to a travel intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult international medical travelers completing a commercial flight of at least 4 hours to Bogota and undergoing all ultrasound measurements before surgery.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Commercial Air Travel ExposureParticipants 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. | Other | Postflight Repeated-Measures Cohort |
| Standardized Bilateral Popliteal Vein Duplex UltrasoundAfter 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. | Diagnostic test | Postflight Repeated-Measures Cohort |
Primary outcome
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.
2 secondary outcomes
Return of Popliteal Vein Diameter to Baseline
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 39431700Hoyos 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.
- Background: PubMed 42110381Ramirez 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.
- Individual participant dataSharing planned: No. not contempled in the patient informed consent
Related trials for Physiologic Venous Dilation
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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
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Recruiting
Randomized Assessor-Masked Trial of Moderate Graduated Compression Stockings for Popliteal Vein Dilation During Long-Haul Economy-Class Air Travel After Aesthetic Surgery
Physiologic Venous Dilation, Air Travel
RecruitingObservational study
Prospective Comparative Cohort Study of Premium Versus Economy Cabin Travel and Popliteal Vein Diameter After Long-Haul Flight After an Aesthetic Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hugo Aguilar, MD, plastic surgery principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physiologic Venous Dilation and Air Travel, run by Research Inc at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hugo Aguilar, MD, Plastic surgeon (+57 301 6918526, havplasticacademy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07808411, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.