Elevate to Alleviate Evidence Based Study (ETA)

Elevate to Alleviate - Evidence Based Nursing Study

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.

Study Overview

• Status: Unknown
• Conditions: Leg Edema; Venous; Return (Anomaly); Leg Elevation
• Intervention / Treatment: Other: Elevation of the legs during bed rest

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Italy
  • Catanzaro, Italy, 88100
    • University Magna Graecia of Catanzaro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Unselected patients with a hospital stay of at least seven days will be recruited and random assigned to two groups of patients of the study.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle and calf diameters measurement	Every Morning Ankle and calf diameters will be measured in centimeters.	at 6 months
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
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
Hours of night sleep	Every Morning Each patient will comunicate the number of hours slept	at 6 months

Collaborators and Investigators

• Sponsor: University of Catanzaro
• Collaborators: University of Roma La Sapienza
• Investigators: Principal Investigator: Nicola Ielapi, R.N., Sapienza University of Rome

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 12, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 17, 2020
• Last Update Submitted That Met QC Criteria: August 12, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: venous returns; lower limbs; leg elevation
• Other Study ID Numbers: ER.ALL.2018.12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No