Randomized Assessor-Masked Trial of Moderate Graduated Compression Stockings for Popliteal Vein Dilation During Long-Haul Economy-Class Air Travel After Aesthetic Surgery
2. september 2026 opdateret af: Research Inc
This randomized assessor-masked trial will evaluate whether knee-high moderate graduated compression stockings reduce popliteal vein dilation during long-haul economy-class air travel to Bogota.
Participants will be assigned to stockings or no stockings and will undergo bilateral ultrasound before flight, within 2 hours after arrival, and at 24 and 48 hours.
The primary outcome is the between-group difference in change in mean bilateral popliteal vein diameter from preflight baseline to arrival.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
Eligible economy-class travelers will be randomized before departure.
The intervention group will wear properly fitted knee-high graduated compression stockings from approximately 1 hour before boarding through the arrival ultrasound; the control group will not use lower-limb compression.
A masked ultrasound assessor will obtain standardized bilateral diameter and cross-sectional-area measurements before flight and at arrival, 24 hours, and 48 hours.
Adherence, movement, hydration, symptoms, and skin effects will be recorded.
Intention-to-treat mixed models will estimate immediate and persistent treatment effects.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
160
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: hugo Aguilar, MD, Plastic surgeon
- Telefonnummer: +57 301 6918526
- E-mail: havplasticacademy@gmail.com
Studiesteder
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-
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Bogotá, Colombia
- Rekruttering
- Clinica INO
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Kontakt:
- hugo Aguilar, MD, Plastic surgeon
- Telefonnummer: +57 3016918526
- E-mail: havplasticacademy@gmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Age 18 to 65 years.
- Economy-class commercial itinerary to Bogota with at least 4 hours of total airborne time.
- No clinical indication that mandates or prohibits compression stockings.
- Ability to obtain the assigned stocking before boarding and wear it as instructed.
- Standardized preflight and postarrival ultrasounds completed before surgery.
- Written informed consent.
Exclusion Criteria:
- Current deep venous thrombosis, therapeutic anticoagulation, or severe peripheral arterial disease.
- Significant lower-limb skin disease, ulceration, neuropathy, or deformity preventing safe stocking use.
- Pregnancy.
- Planned use of another compression device during the flight.
- Surgery or major intravenous fluid therapy before completion of the 48-hour examination.
- Inability to complete preflight ultrasound or follow assigned treatment.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Moderate Compression Stockings
Participants wear properly fitted knee-high graduated compression stockings during the qualifying flight, beginning approximately 1 hour before boarding and removing them after the arrival ultrasound.
all patients got enoxaparin to prevent blood clots
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All patients got enoxaparin to prevent blood clots
PROPOSED pressure class: 20-30 mmHg at the ankle, appropriately sized according to calf and ankle circumference, worn from approximately 1 hour before boarding until completion of the arrival ultrasound.
The final product, pressure class, fitting method, and wear instructions must be confirmed.
Linked arm/group(s): Moderate Compression Stockings.
Triplicate bilateral diameter and cross-sectional-area measurements after a standardized rest period, with compressibility and flow assessment by an assessor masked to allocation.
Linked arm/group(s): Moderate Compression Stockings, No Compression Stockings.
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|
Aktiv komparator: No Compression Stockings
Participants do not wear compression stockings or another lower-limb compression device during the qualifying flight.
All patients got enoxaparin to prevent blood clots
|
All patients got enoxaparin to prevent blood clots
Triplicate bilateral diameter and cross-sectional-area measurements after a standardized rest period, with compressibility and flow assessment by an assessor masked to allocation.
Linked arm/group(s): Moderate Compression Stockings, No Compression Stockings.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference in Change in Mean Bilateral Popliteal Vein Diameter
Tidsramme: Within 24 hours before departure and within 2 hours after arrival at the study site. 2 days
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Between-group difference in baseline-to-arrival change in the mean of triplicate anteroposterior diameter measurements from both legs, reported in millimeters and percent change.
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Within 24 hours before departure and within 2 hours after arrival at the study site. 2 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of Stocking-Related Adverse Effects
Tidsramme: From stocking application through 24 hours after arrival. 5 days
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Proportion with skin injury, numbness, clinically significant pain, intolerance, or early removal attributed to the stocking.
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From stocking application through 24 hours after arrival. 5 days
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Incidental Venous Thrombosis or Abnormal Compressibility
Tidsramme: From preflight baseline through 48 hours after arrival - 1 week
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Number and proportion with an ultrasound abnormality requiring urgent clinical assessment.
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From preflight baseline through 48 hours after arrival - 1 week
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Hugo Aguilar
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2024
Primær færdiggørelse (Faktiske)
1. september 2026
Studieafslutning (Anslået)
1. december 2026
Datoer for studieregistrering
Først indsendt
2. september 2026
Først indsendt, der opfyldte QC-kriterier
2. september 2026
Først opslået (Faktiske)
9. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 017 (Anden identifikator: Nahrain Medical Research Collective (NMRC))
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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