Physiologic Venous DilationNCT07808931
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
A study testing Knee-High Graduated Compression Stockings, Economy Cabin Exposure and Premium Cabin Exposure in people with Physiologic Venous Dilation and Air Travel, run by Research Inc at 1 site in Colombia.
Trial summary
This four-group prospective study will enroll travelers who have independently booked economy or premium business/first-class flights to Bogota. Within each cabin stratum, participants will be randomized to moderate graduated compression stockings or no stockings. 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?
- Knee-High Graduated Compression Stockings, Economy Cabin Exposure and Premium Cabin Exposure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteColombia
- Study dates
- 12 Jan 2024to 1 Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 to 65 years.
- Commercial itinerary to Bogota with at least 4 hours of total airborne time.
- Prebooked premium business/first-class or economy-class cabin documented before randomization.
- No medical requirement for or contraindication to graduated compression stockings.
- Ability to complete standardized ultrasound before flight and through 48 hours after arrival before surgery.
- Written informed consent.
Who cannot join
- Current deep venous thrombosis, therapeutic anticoagulation, or severe peripheral arterial disease.
- Pregnancy.
- Lower-extremity skin, neurologic, or anatomic condition preventing safe stocking use or ultrasound.
- Cabin upgrade or downgrade after randomization that changes the prespecified stratum.
- Surgery or major intravenous fluid therapy before the 48-hour examination.
- Inability to follow the randomized stocking assignment.
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 four-group prospective study will enroll travelers who have independently booked economy or premium business/first-class flights to Bogota. Within each cabin stratum, participants will be randomized to moderate graduated compression stockings or no stockings. Bilateral popliteal vein ultrasound will be performed before flight, within 2 hours after arrival, and at 24 and 48 hours. The primary outcome is the interaction between cabin class and compression assignment for change in mean bilateral popliteal vein diameter.
Read the detailed description
Participants will enter the study according to their prebooked cabin class and then be randomized within that stratum to wear properly fitted knee-high graduated compression stockings or no compression during the flight. The design creates four groups. Standardized bilateral ultrasound will quantify venous diameter and cross-sectional area before departure and through 48 hours after arrival, before surgery. Mixed-effects models will estimate the randomized stocking effect, the adjusted cabin-class association, and their interaction. The protocol will record seat characteristics, ambulation, hydration, adherence, symptoms, and safety events.
- Conditions
- Physiologic Venous Dilation, Air Travel
- Being tested
- Knee-High Graduated Compression Stockings, Economy Cabin Exposure, Premium Cabin Exposure, Standardized Bilateral Popliteal Vein Ultrasound
- Keywords
- Medical Tourism, Duplex Ultrasound, Popliteal Vein, Factorial Design, Compression Stockings, Cabin Class
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee-High Graduated Compression StockingsDevice
PROPOSED pressure class: 20-30 mmHg at the ankle, properly fitted and worn from approximately 1 hour before boarding through the arrival ultrasound. Product and pressure class require confirmation. Linked arm/group(s): Economy Cabin Plus Compression, Premium Cabin Plus Compression.
Economy Cabin ExposureOther
Prebooked and completed economy-cabin travel; seat characteristics and behavior are measured but not assigned. Linked arm/group(s): Economy Cabin Plus Compression, Economy Cabin Without Compression.
Premium Cabin ExposureOther
Prebooked and completed business/first-class travel; seat characteristics and behavior are measured but not assigned. Linked arm/group(s): Premium Cabin Plus Compression, Premium Cabin Without Compression.
Standardized Bilateral Popliteal Vein UltrasoundDiagnostic test
Triplicate bilateral diameter and cross-sectional-area measurements before flight and at arrival, 24 hours, and 48 hours by an assessor masked to stocking allocation. Linked arm/group(s): Economy Cabin Plus Compression, Economy Cabin Without Compression, Premium Cabin Plus Compression, Premium Cabin Without Compression.
| Study group | Role | What they receive |
|---|---|---|
| Economy Cabin Plus Compression | Experimental | Participants with a prebooked economy itinerary randomized to knee-high moderate graduated compression stockings. Receives: Device: Knee-High Graduated Compression Stockings; Other: Economy Cabin Exposure; Diagnostic Test: Standardized Bilateral Popliteal Vein Ultrasound |
| Economy Cabin Without Compression | Active comparator | Participants with a prebooked economy itinerary randomized to no compression stockings. Receives: Other: Economy Cabin Exposure; Diagnostic Test: Standardized Bilateral Popliteal Vein Ultrasound |
| Premium Cabin Plus Compression | Experimental | Participants with a prebooked business/first-class itinerary randomized to knee-high moderate graduated compression stockings. Receives: Device: Knee-High Graduated Compression Stockings; Other: Premium Cabin Exposure; Diagnostic Test: Standardized Bilateral Popliteal Vein Ultrasound |
| Premium Cabin Without Compression | Active comparator | Participants with a prebooked business/first-class itinerary randomized to no compression stockings. Receives: Other: Premium Cabin 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.
Cabin-Class-by-Compression Interaction in Change in Popliteal Vein Diameter
Interaction term between prebooked cabin stratum and randomized stocking assignment for the change in participant-level mean bilateral popliteal vein diameter from preflight baseline to arrival.
Measured: Within 24 hours before departure and within 2 hours after arrival at the study site. 3 days
Secondary outcomes (3)
Randomized Compression Stocking Effect on Arrival-Related Diameter Change
Adjusted mean difference between stocking and no-stocking assignments overall and separately within each cabin stratum.
Measured: Within 24 hours before departure and within 2 hours after arrival. 3 days
Adjusted Cabin-Class Association With Arrival-Related Diameter Change
Adjusted mean difference between premium and economy cabin groups overall and separately by stocking assignment. This contrast is observational because cabin class is not randomized.
Measured: Within 24 hours before departure and within 2 hours after arrival. 3 days
Four-Group Popliteal Vein Diameter Trajectory
Estimated mean bilateral diameter and change from baseline in each of the four groups across postarrival time points.
Measured: Within 24 hours before departure; within 2 hours after arrival; 24 +/- 2 hours; and 48 +/- 2 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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
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
- NCT07808931
- Sponsor's protocol ID
- 018
- 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 concent
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 Stratified Randomized Four-Group Study of Cabin Class and Graduated Compression Stockings on Popliteal Vein Dilation After Long-Haul Air Travel After Aesthetic Surgery
- ClinicalTrials.gov ID
- NCT07808931
- Acronym / sponsor ID
- 018
- Conditions
- Physiologic Venous Dilation, Air Travel
- Keywords
- Medical Tourism, Duplex Ultrasound, Popliteal Vein, Factorial Design, Compression Stockings, Cabin Class
- Study type
- Interventional
- 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 four-group prospective study will enroll travelers who have independently booked economy or premium business/first-class flights to Bogota. Within each cabin stratum, participants will be randomized to moderate graduated compression stockings or no stockings. Bilateral popliteal vein ultrasound will be performed before flight, within 2 hours after arrival, and at 24 and 48 hours. The primary outcome is the interaction between cabin class and compression assignment for change in mean bilateral popliteal vein diameter.
Detailed description
Participants will enter the study according to their prebooked cabin class and then be randomized within that stratum to wear properly fitted knee-high graduated compression stockings or no compression during the flight. The design creates four groups. Standardized bilateral ultrasound will quantify venous diameter and cross-sectional area before departure and through 48 hours after arrival, before surgery. Mixed-effects models will estimate the randomized stocking effect, the adjusted cabin-class association, and their interaction. The protocol will record seat characteristics, ambulation, hydration, adherence, symptoms, and safety events.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Economy Cabin Plus Compression | Experimental | Device: Knee-High Graduated Compression Stockings, Other: Economy Cabin Exposure, Diagnostic Test: Standardized Bilateral Popliteal Vein UltrasoundParticipants with a prebooked economy itinerary randomized to knee-high moderate graduated compression stockings. |
| Economy Cabin Without Compression | Active comparator | Other: Economy Cabin Exposure, Diagnostic Test: Standardized Bilateral Popliteal Vein UltrasoundParticipants with a prebooked economy itinerary randomized to no compression stockings. |
| Premium Cabin Plus Compression | Experimental | Device: Knee-High Graduated Compression Stockings, Other: Premium Cabin Exposure, Diagnostic Test: Standardized Bilateral Popliteal Vein UltrasoundParticipants with a prebooked business/first-class itinerary randomized to knee-high moderate graduated compression stockings. |
| Premium Cabin Without Compression | Active comparator | Other: Premium Cabin Exposure, Diagnostic Test: Standardized Bilateral Popliteal Vein UltrasoundParticipants with a prebooked business/first-class itinerary randomized to no compression stockings. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 65 years.
- Commercial itinerary to Bogota with at least 4 hours of total airborne time.
- Prebooked premium business/first-class or economy-class cabin documented before randomization.
- No medical requirement for or contraindication to graduated compression stockings.
- Ability to complete standardized ultrasound before flight and through 48 hours after arrival before surgery.
Key exclusion criteria (6 listed)
- Current deep venous thrombosis, therapeutic anticoagulation, or severe peripheral arterial disease.
- Pregnancy.
- Lower-extremity skin, neurologic, or anatomic condition preventing safe stocking use or ultrasound.
- Cabin upgrade or downgrade after randomization that changes the prespecified stratum.
- Surgery or major intravenous fluid therapy before the 48-hour examination.
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 |
|---|---|---|
| Knee-High Graduated Compression StockingsPROPOSED pressure class: 20-30 mmHg at the ankle, properly fitted and worn from approximately 1 hour before boarding through the arrival ultrasound. Product and pressure class require confirmation. Linked arm/group(s): Economy Cabin Plus Compression, Premium Cabin Plus Compression. | Device | Economy Cabin Plus Compression, Premium Cabin Plus Compression |
| Economy Cabin ExposurePrebooked and completed economy-cabin travel; seat characteristics and behavior are measured but not assigned. Linked arm/group(s): Economy Cabin Plus Compression, Economy Cabin Without Compression. | Other | Economy Cabin Plus Compression, Economy Cabin Without Compression |
| Premium Cabin ExposurePrebooked and completed business/first-class travel; seat characteristics and behavior are measured but not assigned. Linked arm/group(s): Premium Cabin Plus Compression, Premium Cabin Without Compression. | Other | Premium Cabin Plus Compression, Premium Cabin Without Compression |
| Standardized Bilateral Popliteal Vein UltrasoundTriplicate bilateral diameter and cross-sectional-area measurements before flight and at arrival, 24 hours, and 48 hours by an assessor masked to stocking allocation. Linked arm/group(s): Economy Cabin Plus Compression, Economy Cabin Without Compression, Premium Cabin Plus Compression, Premium Cabin Without Compression. | Diagnostic test | Economy Cabin Plus Compression, Economy Cabin Without Compression, Premium Cabin Plus Compression, Premium Cabin Without Compression |
Primary outcome
Cabin-Class-by-Compression Interaction in Change in Popliteal Vein Diameter
Time frame: Within 24 hours before departure and within 2 hours after arrival at the study site. 3 days
Interaction term between prebooked cabin stratum and randomized stocking assignment for the change in participant-level mean bilateral popliteal vein diameter from preflight baseline to arrival.
3 secondary outcomes
Randomized Compression Stocking Effect on Arrival-Related Diameter Change
Time frame: Within 24 hours before departure and within 2 hours after arrival. 3 days
Adjusted Cabin-Class Association With Arrival-Related Diameter Change
Time frame: Within 24 hours before departure and within 2 hours after arrival. 3 days
Four-Group Popliteal Vein Diameter Trajectory
Time frame: Within 24 hours before departure; within 2 hours after arrival; 24 +/- 2 hours; and 48 +/- 2 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.
- Individual participant dataSharing planned: No. not contempled in the patient informed concent
Related trials for Physiologic Venous Dilation
RecruitingObservational study
Prospective Comparative Cohort Study of Premium Versus Economy Cabin Travel and Popliteal Vein Diameter After Long-Haul Flight After an 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?
A study testing Knee-High Graduated Compression Stockings, Economy Cabin Exposure and Premium Cabin Exposure in people with 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?
Cabin-Class-by-Compression Interaction in Change in 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?
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.