Clinical trial NCT04514939: Elevate to Alleviate Evidence Based Study
Official title: Elevate to Alleviate - Evidence Based Nursing Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Leg Edema
Venous; Return (Anomaly)
Leg Elevation
Keywords: venous returns
lower limbs
leg elevation
Lead sponsor: University of Catanzaro
Sponsor class: OTHER
Collaborators: name: University of Roma La Sapienza
First posted: 2020-08-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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).

Eligibility 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.

Primary outcomes:
measure: Ankle and calf diameters measurement
timeFrame: at 6 months
measure: Legs heaviness evaluation
timeFrame: at 6 months
measure: Perceived leg comfort evaluation
timeFrame: at 6 months
measure: Hours of night sleep
timeFrame: at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: University Magna Graecia of Catanzaro
Study officials:
affiliation: University of Roma La Sapienza
name: Nicola Ielapi, R.N.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.