Physiologic Venous DilationNCT07810179
Prospective Comparative Cohort Study of Premium Versus Economy Cabin Travel and Popliteal Vein Diameter After Long-Haul Flight After an Aesthetic Surgery
An observational study of Physiologic Venous Dilation and Air Travel, run by Research Inc at 1 site in Colombia.
Trial 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. 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?
- Premium Cabin Air Travel Exposure, Economy Cabin Air Travel Exposure and Standardized Bilateral Popliteal Vein Ultrasound
- How many people
- 200 participants
- Where
- 1 siteColombia
- Study dates
- 12 Jan 2024to 1 Dec 2026
- How long will I take part?
- 1 Month
- 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 with prebooked premium business/first-class or economy-class itineraries of at least 4 hours.
Who may be able to join
- 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.
Who cannot join
- 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.
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 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.
Read the detailed description
Travelers with documented premium or economy itineraries will be enrolled before departure. Bilateral popliteal vein diameter and cross-sectional area will be measured using a standardized ultrasound protocol before flight and three times after arrival, all before surgery. Actual seat characteristics, flight duration, connections, ambulation, fluid intake, alcohol, sedatives, and compression stocking use will be recorded. Mixed-effects and propensity-weighted analyses will compare the magnitude and persistence of dilation between cabin groups while acknowledging that cabin class is not randomized.
- Conditions
- Physiologic Venous Dilation, Air Travel
- Being tested
- Premium Cabin Air Travel Exposure, Economy Cabin Air Travel Exposure, Standardized Bilateral Popliteal Vein Ultrasound
- Keywords
- Cabin Class, Business Class, First Class, Economy Class, Popliteal Vein, Duplex Ultrasound, Medical Tourism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premium Cabin Air Travel ExposureOther
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 ExposureOther
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 UltrasoundDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Premium Cabin Travelers | Participants who independently booked and completed the qualifying itinerary in business or first class. Receives: Other: Premium Cabin Air Travel Exposure; Diagnostic Test: Standardized Bilateral Popliteal Vein Ultrasound | |
| Economy Cabin Travelers | Participants who independently booked and completed the qualifying itinerary in economy or basic economy class. Receives: Other: Economy Cabin Air Travel Exposure; Diagnostic Test: Standardized Bilateral Popliteal Vein Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From preflight baseline through 48 hours after arrival. 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 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
- 200 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hugo Aguilar, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810179
- Sponsor's protocol ID
- 016
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 9 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
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.
PubMed 42110381Hoyos 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 39431700
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Cohort Study of Premium Versus Economy Cabin Travel and Popliteal Vein Diameter After Long-Haul Flight After an Aesthetic Surgery
- ClinicalTrials.gov ID
- NCT07810179
- Acronym / sponsor ID
- 016
- Conditions
- Physiologic Venous Dilation, Air Travel
- Keywords
- Cabin Class, Business Class, First Class, Economy Class, Popliteal Vein, Duplex Ultrasound, Medical Tourism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 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
- 9 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 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.
Detailed description
Travelers with documented premium or economy itineraries will be enrolled before departure. Bilateral popliteal vein diameter and cross-sectional area will be measured using a standardized ultrasound protocol before flight and three times after arrival, all before surgery. Actual seat characteristics, flight duration, connections, ambulation, fluid intake, alcohol, sedatives, and compression stocking use will be recorded. Mixed-effects and propensity-weighted analyses will compare the magnitude and persistence of dilation between cabin groups while acknowledging that cabin class is not randomized.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premium Cabin Travelers | – | Other: Premium Cabin Air Travel Exposure, Diagnostic Test: Standardized Bilateral Popliteal Vein UltrasoundParticipants who independently booked and completed the qualifying itinerary in business or first class. |
| Economy Cabin Travelers | – | Other: Economy Cabin Air Travel Exposure, Diagnostic Test: Standardized Bilateral Popliteal Vein UltrasoundParticipants who independently booked and completed the qualifying itinerary in economy or basic economy class. |
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 with prebooked premium business/first-class or economy-class itineraries of at least 4 hours.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Premium Cabin Air Travel ExposurePreexisting 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. | Other | Premium Cabin Travelers |
| Economy Cabin Air Travel ExposurePreexisting economy-cabin exposure with documentation of seat characteristics, position, movement, hydration, and other travel behaviors. Linked arm/group(s): Economy Cabin Travelers. | Other | Economy Cabin Travelers |
| Standardized Bilateral Popliteal Vein UltrasoundTriplicate 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. | Diagnostic test | Economy Cabin Travelers, Premium Cabin Travelers |
Primary outcome
Between-Cabin Difference in Change in Mean Bilateral Popliteal Vein Diameter
Time frame: Within 24 hours before departure and within 2 hours after arrival at the study site. 3 days
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.
1 secondary outcome
Incidental Venous Thrombosis or Abnormal Compressibility
Time frame: From preflight baseline through 48 hours after arrival. 3 days
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 9 Sep 2026.
- 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.
- 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.
- Individual participant dataSharing planned: No. not contempled in the patient informed consent
Related trials for Physiologic Venous Dilation
Recruiting
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
Physiologic Venous Dilation, Air Travel
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 Repeated-Measures Study of Popliteal Vein Diameter During the First 48 Hours After Commercial Air Travel to Bogota for a Plastic Surgery Intervention
Physiologic Venous Dilation, Air Travel
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 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 9 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?
Between-Cabin Difference in Change in Mean Bilateral Popliteal Vein Diameter (time frame: Within 24 hours before departure and within 2 hours after arrival at the study site. 3 days). 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 NCT07810179, 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 9 Sep 2026.