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临床试验/NCT04514939
NCT04514939Unknown不适用

Elevate to Alleviate - Evidence Based Nursing Study

University of Catanzaro1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Legs heaviness evaluation

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Every hospital inpatient with at least 7 hospital stay.

排除标准

  • Patients with vascular or osteoarticular leg problems that affect or prevent leg elevation during rest.

结局指标

主要结局

Legs heaviness evaluation

时间窗: at 6 months

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)

Perceived leg comfort evaluation

时间窗: at 6 months

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)

Ankle and calf diameters measurement

时间窗: at 6 months

Every Morning Ankle and calf diameters will be measured in centimeters.

Hours of night sleep

时间窗: at 6 months

Every Morning Each patient will comunicate the number of hours slept

次要结局

未报告次要终点

研究者

发起方
University of Catanzaro
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Raffaele Serra, MD, Ph.D.

Associate Professor of Vascular Surgery

University of Catanzaro

研究点 (1)

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