Elevate to Alleviate Evidence Based Study (ETA)

University of Catanzaro

Status: Unknown

Conditions: Leg Elevation; Leg Edema; Venous; Return (Anomaly)

Treatments: Other: Elevation of the legs during bed rest

Study type: Observational

Funder types: Other

Identifiers

NCT04514939

ER.ALL.2018.12

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

Group A - Leg elevation

Description:

Patients will lie in their hospital bed with a moderate leg elevation (between 15 and 30 degrees)

Treatment:

Other: Elevation of the legs during bed rest

Group B- Non Leg elevation

Description:

Patients will lie in their hospital bed without leg elevation