ETA: Elevate to Alleviate Evidence Based Study
Study Details
Study Description
Brief Summary
Venous return in the circulatory system of lower limbs results from the interaction of several mechanisms, and reflects the balance between blood inflow and outflow. Blood outflow improves during sleeping because of the lying position especially with leg elevation. In fact, patients with chronic venous disease (CVD) improve leg symptoms in lying position and with leg elevation.
The aim of this study is to evaluate the level of comfort of hospital inpatients, without CVD, if they lie with a moderate leg elevation during hospital stay.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The venous system makes the blood return to the heart with low-pressure and slow-velocity flow, within the venous system. Venous return results from the interaction of diverse mechanisms, such a central pump (respiratory cycle and the heart), a pressure gradient, a peripheral venous muscular pump, and the veins valvular system. Therefore, the venous volume in the lower limb is the result of the interaction between these mechanisms and reflects the balance between blood inflow and outflow. Blood outflow improves during sleeping because of the lying position and, in this position, even more with leg elevation. In fact, it is known patients with chronic venous disease (CVD) improve leg symptoms in lying position and with leg elevation.
The aim of this study is to evaluate the level of comfort of hospital inpatients, without CVD, if they lie with a moderate leg elevation during hospital stay.
Unselected patients with a hospital stay of at least seven days will be recruited and random assigned to two groups of patients: Group A, that will lie in their hospital bed with a moderate leg elevation (between 15 and 30 degrees). Group B, that will lie in their hospital bed without leg elevation.
All patients will undergo echo duplex scanning of vascular system of lower limbs to exclude any vascular disease.
For every patient complete demographic and comorbidity data will be collected. Every single the day, the following parameters will be retrieved for each patient: ankle and calf diameters, heart rate, blood pressure, breath frequency, body temperature, leg heaviness (rating scale 1-10), perceived leg comfort (rating scale 1-10), hours of night sleep (number).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group A - Leg elevation Patients will lie in their hospital bed with a moderate leg elevation (between 15 and 30 degrees) |
Other: Elevation of the legs during bed rest
Patients of Group A will will lie in their hospital bed with a moderate leg elevation (between 15 and 30 degrees)
|
| Group B- Non Leg elevation Patients will lie in their hospital bed without leg elevation |
Outcome Measures
Primary Outcome Measures
- Ankle and calf diameters measurement [at 6 months]
Every Morning Ankle and calf diameters will be measured in centimeters.
- Legs heaviness evaluation [at 6 months]
Every Morning Each patient will comunicate his/her perception of legs heaviness using a rating scale (1-10: 1 is absence of heaviness and 10 is high heaviness)
- Perceived leg comfort evaluation [at 6 months]
Every Morning Each patient will comunicate his/her perception of legs heaviness using a rating scale (1-10: 1 is minimum comfort and 10 is maximum comfort)
- Hours of night sleep [at 6 months]
Every Morning Each patient will comunicate the number of hours slept
Eligibility Criteria
Criteria
Inclusion Criteria:
- Every hospital inpatient with at least 7 hospital stay.
Exclusion Criteria:
- Patients with vascular or osteoarticular leg problems that affect or prevent leg elevation during rest.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Magna Graecia of Catanzaro | Catanzaro | Italy | 88100 |
Sponsors and Collaborators
- University of Catanzaro
- University of Roma La Sapienza
Investigators
- Principal Investigator: Nicola Ielapi, R.N., Sapienza University of Rome
Study Documents (Full-Text)
None provided.More Information
Publications
- Liaw MY, Wong MK. [The effects of leg elevation to reduce leg edema resulting from prolonged standing]. Taiwan Yi Xue Hui Za Zhi. 1989 Jun;88(6):630-4, 628. Chinese.
- Sugisawa R, Unno N, Saito T, Yamamoto N, Inuzuka K, Tanaka H, Sano M, Katahashi K, Uranaka H, Marumo T, Konno H. Effects of Compression Stockings on Elevation of Leg Lymph Pumping Pressure and Improvement of Quality of Life in Healthy Female Volunteers: A Randomized Controlled Trial. Lymphat Res Biol. 2016 Jun;14(2):95-103. doi: 10.1089/lrb.2015.0045. Epub 2016 Jan 29.
- ER.ALL.2018.12