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
7 de setembro de 2026 atualizado por: Research Inc
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.
Visão geral do estudo
Status
Recrutamento
Condições
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
200
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: hugo Aguilar, MD, Plastic surgeon
- Número de telefone: +57 301 6918526
- E-mail: havplasticacademy@gmail.com
Locais de estudo
-
-
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Bogotá, Colômbia
- Recrutamento
- Clinica INO
-
Contato:
- hugo Aguilar, MD, Plastic surgeon
- Número de telefone: +57 3016918526
- E-mail: havplasticacademy@gmail.com
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Economy Cabin Plus Compression
Participants with a prebooked economy itinerary randomized to knee-high moderate graduated compression stockings.
|
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.
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.
|
|
Comparador Ativo: Economy Cabin Without Compression
Participants with a prebooked economy itinerary randomized to no compression stockings.
|
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.
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.
|
|
Experimental: Premium Cabin Plus Compression
Participants with a prebooked business/first-class itinerary randomized to knee-high moderate graduated compression stockings.
|
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.
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.
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.
|
|
Comparador Ativo: Premium Cabin Without Compression
Participants with a prebooked business/first-class itinerary randomized to no compression stockings.
|
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.
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Cabin-Class-by-Compression Interaction in Change in Popliteal Vein Diameter
Prazo: 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.
|
Within 24 hours before departure and within 2 hours after arrival at the study site. 3 days
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Randomized Compression Stocking Effect on Arrival-Related Diameter Change
Prazo: Within 24 hours before departure and within 2 hours after arrival. 3 days
|
Adjusted mean difference between stocking and no-stocking assignments overall and separately within each cabin stratum.
|
Within 24 hours before departure and within 2 hours after arrival. 3 days
|
|
Adjusted Cabin-Class Association With Arrival-Related Diameter Change
Prazo: Within 24 hours before departure and within 2 hours after arrival. 3 days
|
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.
|
Within 24 hours before departure and within 2 hours after arrival. 3 days
|
|
Four-Group Popliteal Vein Diameter Trajectory
Prazo: Within 24 hours before departure; within 2 hours after arrival; 24 +/- 2 hours; and 48 +/- 2 hours after arrival. 3 days
|
Estimated mean bilateral diameter and change from baseline in each of the four groups across postarrival time points.
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Within 24 hours before departure; within 2 hours after arrival; 24 +/- 2 hours; and 48 +/- 2 hours after arrival. 3 days
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Hugo Aguilar
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
12 de janeiro de 2024
Conclusão Primária (Real)
1 de setembro de 2026
Conclusão do estudo (Estimado)
1 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
2 de setembro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de setembro de 2026
Primeira postagem (Real)
9 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 018
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
not contempled in the patient informed concent
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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