Elevate to Alleviate Evidence Based Study

NCT ID: NCT04514939

Last Updated: 2020-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-08-31

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).

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A - Leg elevation

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

Elevation of the legs during bed rest

Intervention Type: OTHER

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

No interventions assigned to this group

Interventions

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)

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: collaborator

University of Catanzaro

OTHER

Sponsor Role: lead

Responsible Party

Prof. Raffaele Serra, MD, Ph.D.

Associate Professor of Vascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicola Ielapi, R.N.

Role: PRINCIPAL_INVESTIGATOR

University of Roma La Sapienza

Locations

University Magna Graecia of Catanzaro

Catanzaro, , Italy

Countries

Italy

Central Contacts

Raffaele Serra, M.D., Ph.D.

Role: CONTACT

rserra@unicz.it

+3909613647380

References

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.

Reference Type: BACKGROUND

PMID: 2794965 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26824795 (View on PubMed)

Other Identifiers

ER.ALL.2018.12

Identifier Type: -

Identifier Source: org_study_id