Edema Leg Clinical Trial
Official title:
The Effect of Compression Stockings on Edema and Discomfort During Short Haul Flights: A Randomized Controlled Trial
NCT number | NCT03546725 |
Other study ID # | 8392100 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 8, 2018 |
Est. completion date | May 26, 2018 |
Verified date | June 2018 |
Source | Herlev and Gentofte Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | May 26, 2018 |
Est. primary completion date | May 26, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult participants = 18 years of both sexes. Otherwise no restriction, since each participant acts as their own control. Exclusion Criteria: - Any condition requiring compression stockings during short-haul flights. Severe arterial insufficiency in the lower extremities. |
Country | Name | City | State |
---|---|---|---|
Denmark | Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Herlev and Gentofte Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ankle edema | Difference in ankle circumference pre- and post flight on the leg with and the leg without compression stocking. | 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. | |
Secondary | Calf edema | Difference in calf circumference pre- and post flight on the leg with and the leg without compression stocking. | 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. | |
Secondary | Leg pain | Self-reported assessment of leg pain on a Visual Analogue Scale. | Leg pain is reported up to one hour before, and one hour after flight. | |
Secondary | Leg discomfort | Self-reported assessment of leg discomfort on a Visual Analogue Scale. | Leg discomfort is reported up to one hour before, and one hour after flight. |
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