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Completed

NCT Number: NCT03546725

The Effect of Compression Stockings on Edema and Discomfort During Short Haul Flights

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.

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Key information

Conditions

Edema Leg

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen

Copenhagen, 2730, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Compression stocking

Device

Compression stocking with length below the knee and a class two compression level (corresponding to 23-32 mmHg compression).

Primary outcomes

  1. Ankle edema

    Time frame: 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.

Secondary outcomes

  1. Calf edema

    Time frame: 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.

    Difference in calf circumference pre- and post flight on the leg with and the leg without compression stocking.

  2. Leg pain

    Time frame: Leg pain is reported up to one hour before, and one hour after flight.

    Self-reported assessment of leg pain on a Visual Analogue Scale.

  3. Leg discomfort

    Time frame: Leg discomfort is reported up to one hour before, and one hour after flight.

    Self-reported assessment of leg discomfort on a Visual Analogue Scale.

Sponsors and collaborators

Lead sponsor

Herlev and Gentofte Hospital

Other

Registry information

Official study title

The Effect of Compression Stockings on Edema and Discomfort During Short Haul Flights: A Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 6, 2018
Registry last updated
Jun 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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