Clinical trial NCT03546725: The Effect of Compression Stockings on Edema and Discomfort During Short Haul Flights
Official title: The Effect of Compression Stockings on Edema and Discomfort During Short Haul Flights: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edema Leg
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomised to wear a compression stocking on either the left or the right leg during a 3 - 3.5 hour flight. All participants will act as their own control, and as a result all data will be paired.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ankle edema
timeFrame: 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 outcomes:
measure: Calf edema
timeFrame: 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.
measure: Leg pain
timeFrame: Leg pain is reported up to one hour before, and one hour after flight.
measure: Leg discomfort
timeFrame: Leg discomfort is reported up to one hour before, and one hour after flight.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen
Study officials:
affiliation: Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen
name: Joachim HH Olsen, BScMed
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen
name: Stina Öberg, MD
role: STUDY_DIRECTOR
affiliation: Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen
name: Jacob Rosenberg, MD, DMSc
role: STUDY_DIRECTOR
References:
citation: Olsen JHH, Oberg S, Rosenberg J. The effect of compression stocking on leg edema and discomfort during a 3-hour flight: A randomized controlled trial. Eur J Intern Med. 2019 Apr;62:54-57. doi: 10.1016/j.ejim.2019.01.013. Epub 2019 Feb 7.