Elevate to Alleviate Evidence Based Study

Leg Edema Clinical Trial

— ETA  

Official title:

Elevate to Alleviate - Evidence Based Nursing Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04514939
• Other study ID #: ER.ALL.2018.12
• Status: Not yet recruiting
• Start date: September 1, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: August 2020
• Source: University of Catanzaro
• Contact: Raffaele Serra, M.D., Ph.D.
• Phone: +3909613647380
• Email: rserra[@]unicz.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 31, 2021
• Est. primary completion date: March 1, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Leg Edema
• Leg Elevation
• Venous; Return (Anomaly)

Intervention

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)

Locations

Country	Name	City	State
Italy	University Magna Graecia of Catanzaro	Catanzaro

Sponsors (2)

Lead Sponsor	Collaborator
University of Catanzaro	University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ankle and calf diameters measurement	Every Morning Ankle and calf diameters will be measured in centimeters.	at 6 months
Primary	Legs heaviness evaluation	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)	at 6 months
Primary	Perceived leg comfort evaluation	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)	at 6 months
Primary	Hours of night sleep	Every Morning Each patient will comunicate the number of hours slept	at 6 months