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
2026年9月7日 更新者：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.
研究概览
地位
招聘中
详细说明
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.
研究类型
介入性
注册 (估计的)
200
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：hugo Aguilar, MD, Plastic surgeon
- 电话号码：+57 301 6918526
- 邮箱：havplasticacademy@gmail.com
学习地点
-
-
-
Bogotá、哥伦比亚
- 招聘中
- Clinica INO
-
接触：
- hugo Aguilar, MD, Plastic surgeon
- 电话号码：+57 3016918526
- 邮箱：havplasticacademy@gmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
|
有源比较器：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.
|
|
实验性的：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.
|
|
有源比较器：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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cabin-Class-by-Compression Interaction in Change in Popliteal Vein Diameter
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Randomized Compression Stocking Effect on Arrival-Related Diameter Change
大体时间：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
|
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Adjusted Cabin-Class Association With Arrival-Related Diameter Change
大体时间：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
大体时间：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.
|
Within 24 hours before departure; within 2 hours after arrival; 24 +/- 2 hours; and 48 +/- 2 hours after arrival. 3 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Hugo Aguilar
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年1月12日
初级完成 (实际的)
2026年9月1日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2026年9月2日
首先提交符合 QC 标准的
2026年9月7日
首次发布 (实际的)
2026年9月9日
研究记录更新
最后更新发布 (实际的)
2026年9月9日
上次提交的符合 QC 标准的更新
2026年9月7日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- 018
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
not contempled in the patient informed concent
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.