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

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

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.

Study Overview

• Status: Completed
• Conditions: Edema Leg
• Intervention / Treatment: Device: Compression stocking

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2730
    • Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Leg with compression stocking; Leg wearing compression stocking during the flight	Device: Compression stocking; Compression stocking with length below the knee and a class two compression level (corresponding to 23-32 mmHg compression).
No Intervention: Leg without compression stocking; Leg not wearing compression stocking during the flight

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Herlev and Gentofte Hospital
• Investigators: Principal Investigator: Joachim HH Olsen, BScMed, Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen; Study Director: Stina Öberg, MD, Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen; Study Director: Jacob Rosenberg, MD, DMSc, Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2018
• Primary Completion (Actual): May 26, 2018
• Study Completion (Actual): May 26, 2018

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): June 13, 2018
• Last Update Submitted That Met QC Criteria: June 12, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Edema
• Other Study ID Numbers: 8392100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No