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

NCT ID: NCT03546725

Last Updated: 2018-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-08
• Study Completion Date: 2018-05-26

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.

Conditions

Edema Leg

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Leg with compression stocking

Leg wearing compression stocking during the flight

Group Type: EXPERIMENTAL

Compression stocking

Intervention Type: DEVICE

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

Leg without compression stocking

Leg not wearing compression stocking during the flight

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Compression stocking

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Herlev and Gentofte Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joachim Hjalde Halmsted Olsen

Bachelor of Medical Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joachim HH Olsen, BScMed

Role: PRINCIPAL_INVESTIGATOR

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

Stina Öberg, MD

Role: STUDY_DIRECTOR

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

Jacob Rosenberg, MD, DMSc

Role: STUDY_DIRECTOR

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

Locations

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

Copenhagen, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 30738701 (View on PubMed)

Other Identifiers

8392100

Identifier Type: -

Identifier Source: org_study_id