The Effect of Compression Stockings on Edema and Discomfort During Short Haul Flights: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Ankle edema
研究概览
简要总结
Compression stockings have beneficial effects on the development of venous thromboembolic complications and oedema during long- haul flights. A randomized controlled trial investigating the effect of compression stockings during short-haul flights with a duration less than fur ours is lacking. Deep vein thrombosis is very rare on flights shorter than four hours, but compression stocking could have beneficial effects on other outcomes. The aim of this study is to assess if compression stockings used during a 3-3.5-hour flight will decrease leg edema and discomfort.
详细描述
All participants will be adults who will undergo a 3-3.5 hours flight. Participants have received oral and written information about the trial. All compression stockings have a class two compression level (corresponding to 23-32 mmHg compression). Participants will be randomized to wear a compression stocking on one leg, while the other side acts as control. Within an hour preflight, the patient will measure ankle and calf circumference at marked circumferential areas on the leg and answer questionnaires regarding leg pain and subjective discomfort, whereafter the stocking will be put on, on the randomized side. Within one hour after the flight the stocking will be removed and patients will once again measure the ankle and calf circumference at the marked circumference and fill out the questionnaire.
Sample size: Mean difference in ankle circumference set to -0.19 cm. Standard deviation of the mean difference set to 0.3, 5% alfa and 80% power. Sample size with a paired design = at least 18 participants. However, for practical reasons we will include up to approximately 50 adults in the trial.
Withdrawal and dropout criteria: All participants can withdraw their consent at any point during the trial, without the need for explaining any reasons for withdrawal. Since compression stockings do not cause side effects, except for patients with severe arterial insufficiency in the legs, we do not expect the trial to be stopped due to complications. All withdrawals will be accounted for in the scientific publication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes will be self-reported, and the author that assesses the outcomes and performs data analyses will be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult participants ≥ 18 years of both sexes. Otherwise no restriction, since each participant acts as their own control.
排除标准
- •Any condition requiring compression stockings during short-haul flights. Severe arterial insufficiency in the lower extremities.
研究组 & 干预措施
Leg with compression stocking
Leg wearing compression stocking during the flight
干预措施: Compression stocking (Device)
Leg without compression stocking
Leg not wearing compression stocking during the flight
结局指标
主要结局
Ankle edema
时间窗: Ankle circumference on the leg wearing a compression stocking and the leg not wearing compression stocking is measured up to one hour before, and one hour after flight.
Difference in ankle circumference pre- and post flight on the leg with and the leg without compression stocking.
次要结局
- Calf edema(Calf circumference on the leg wearing a compression stocking and the leg not wearing compression stocking is measured up to one hour before, and one hour after flight.)
- Leg pain(Leg pain is reported up to one hour before, and one hour after flight.)
- Leg discomfort(Leg discomfort is reported up to one hour before, and one hour after flight.)
研究者
Joachim Hjalde Halmsted Olsen
Bachelor of Medical Science
Herlev and Gentofte Hospital