The Effect of Compression Stockings on Edema and Discomfort During Short Haul Flights
Primary Purpose
Edema Leg
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Compression stocking
Sponsored by
About this trial
This is an interventional prevention trial for Edema Leg
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.
Sites / Locations
- Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Leg with compression stocking
Leg without compression stocking
Arm Description
Leg wearing compression stocking during the flight
Leg not wearing compression stocking during the flight
Outcomes
Primary Outcome Measures
Ankle edema
Difference in ankle circumference pre- and post flight on the leg with and the leg without compression stocking.
Secondary Outcome Measures
Calf edema
Difference in calf circumference pre- and post flight on the leg with and the leg without compression stocking.
Leg pain
Self-reported assessment of leg pain on a Visual Analogue Scale.
Leg discomfort
Self-reported assessment of leg discomfort on a Visual Analogue Scale.
Full Information
NCT ID
NCT03546725
First Posted
May 23, 2018
Last Updated
June 12, 2018
Sponsor
Herlev and Gentofte Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03546725
Brief Title
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
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
May 26, 2018 (Actual)
Study Completion Date
May 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev and Gentofte Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edema Leg
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Outcomes will be self-reported, and the author that assesses the outcomes and performs data analyses will be blinded.
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Leg with compression stocking
Arm Type
Experimental
Arm Description
Leg wearing compression stocking during the flight
Arm Title
Leg without compression stocking
Arm Type
No Intervention
Arm Description
Leg not wearing compression stocking during the flight
Intervention Type
Device
Intervention Name(s)
Compression stocking
Intervention Description
Compression stocking with length below the knee and a class two compression level (corresponding to 23-32 mmHg compression).
Primary Outcome Measure Information:
Title
Ankle edema
Description
Difference in ankle circumference pre- and post flight on the leg with and the leg without compression stocking.
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.
Secondary Outcome Measure Information:
Title
Calf edema
Description
Difference in calf circumference pre- and post flight on the leg with and the leg without compression stocking.
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.
Title
Leg pain
Description
Self-reported assessment of leg pain on a Visual Analogue Scale.
Time Frame
Leg pain is reported up to one hour before, and one hour after flight.
Title
Leg discomfort
Description
Self-reported assessment of leg discomfort on a Visual Analogue Scale.
Time Frame
Leg discomfort is reported up to one hour before, and one hour after flight.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joachim HH Olsen, BScMed
Organizational Affiliation
Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stina Öberg, MD
Organizational Affiliation
Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jacob Rosenberg, MD, DMSc
Organizational Affiliation
Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen
Official's Role
Study Director
Facility Information:
Facility Name
Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2730
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30738701
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.
Results Reference
derived
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The Effect of Compression Stockings on Edema and Discomfort During Short Haul Flights
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