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

NCT03546725 | Completed

• 1 other identifier: 8392100
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Edema Leg

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

Study Arms (2)

Leg with compression stocking

EXPERIMENTAL

Leg wearing compression stocking during the flight

Device: Compression stocking

Leg without compression stocking

NO INTERVENTION

Leg not wearing compression stocking during the flight

Interventions

Compression stocking DEVICE

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

Leg with compression stocking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult participants ≥ 18 years of both sexes. Otherwise no restriction, since each participant acts as their own control.

You may not qualify if:

• Any condition requiring compression stockings during short-haul flights. Severe arterial insufficiency in the lower extremities.

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead

Study Sites (1)

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

Copenhagen, 2730, Denmark

Location

Related Publications (1)

• 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.

  PMID: 30738701 DERIVED

MeSH Terms

Interventions

Stockings, Compression

Intervention Hierarchy (Ancestors)

Compression Bandages; Bandages; Equipment and Supplies

Study Officials

• Joachim HH Olsen, BScMed

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

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes will be self-reported, and the author that assesses the outcomes and performs data analyses will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bachelor of Medical Science

Model Details: 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.

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 6, 2018
• Study Start: February 8, 2018
• Primary Completion: May 26, 2018
• Study Completion: May 26, 2018
• Last Updated: June 13, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)