An interventional study of Knee-High Graduated Compression Stockings and Economy Cabin Exposure in Physiologic Venous Dilation and Air Travel, sponsored by Research Inc. Recruiting at 1 site in Colombia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Research Inc · Not applicable, Interventional, and Prevention
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.
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.
Research Inc is the lead sponsor of 24 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with a prebooked economy itinerary randomized to knee-high moderate graduated compression stockings.
Device: Knee-High Graduated Compression Stockings · Other: Economy Cabin Exposure · Diagnostic Test: Standardized Bilateral Popliteal Vein Ultrasound
Participants with a prebooked economy itinerary randomized to no compression stockings.
Other: Economy Cabin Exposure · Diagnostic Test: Standardized Bilateral Popliteal Vein Ultrasound
Participants with a prebooked business/first-class itinerary randomized to knee-high moderate graduated compression stockings.
Device: Knee-High Graduated Compression Stockings · Other: Premium Cabin Exposure · Diagnostic Test: Standardized Bilateral Popliteal Vein Ultrasound
Participants with a prebooked business/first-class itinerary randomized to no compression stockings.
Other: Premium Cabin Exposure · Diagnostic Test: Standardized Bilateral Popliteal Vein Ultrasound
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.
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.
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.
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.
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.
Time frame: Within 24 hours before departure and within 2 hours after arrival at the study site. 3 days
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.
Time frame: 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.
Time frame: 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.
Time frame: Within 24 hours before departure; within 2 hours after arrival; 24 +/- 2 hours; and 48 +/- 2 hours after arrival. 3 days
Plan to share: No — not contempled in the patient informed concent
No publications or documents are linked to this record.
Ran from Jan 2024 to primary completion in Sep 2026, 31 months.
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