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Elevate to Alleviate Evidence Based Study

Elevate to Alleviate - Evidence Based Nursing Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04514939
Acronym
ETA
Enrollment
100
Registered
2020-08-17
Start date
2020-09-01
Completion date
2021-08-31
Last updated
2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leg Edema, Leg Elevation, Venous; Return (Anomaly)

Keywords

venous returns, lower limbs, leg elevation

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).

Interventions

OTHERElevation 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)

Sponsors

University of Roma La Sapienza
CollaboratorOTHER
University of Catanzaro
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Ankle and calf diameters measurementat 6 monthsEvery Morning Ankle and calf diameters will be measured in centimeters.
Legs heaviness evaluationat 6 monthsEvery 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 evaluationat 6 monthsEvery 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 sleepat 6 monthsEvery Morning Each patient will comunicate the number of hours slept

Countries

Italy

Contacts

Primary ContactRaffaele Serra, M.D., Ph.D.
rserra@unicz.it+3909613647380

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026