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临床试验/NCT05436340
NCT05436340招募中不适用

THE EFFECT OF THE USE OF HEEL PROTECTORS ON THE PREVENTION OF HEEL PRESSURE SORES AND PLANTAR FLEXION CONTRACTURES IN INTENSIVE CARE UNITS

Maltepe University1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
84
试验地点
1
主要终点
Foot Joint Opening

研究概览

简要总结

Purpose: It was aimed to evaluate the effectiveness of using heel protector products for the prevention of heel pressure sore and plantar flexion contracture in patients hospitalized in intensive care units for a long time.

Design: The study is conducted as a Randomized Controlled Study. Method: Heel protectors will be used in the intervention group among the patients in the intensive care unit who meet the inclusion criteria of the study, and the control group will be positioned with a pillow, which is the standard practice. As calculated in the G-Power program with reference to the source, a total of 42 patients were determined to be included in the intervention group and 42 patients in the control group. These patients will be followed for a total of 14 days. Heel Scalp Evaluation and Goniometric Measurements will be made according to Braden Pressure Wound Risk Assessment Scale, Ramsey Sedation Scale, NPUAP and EPUAP Staging System and recorded in the data collection form created by the researcher.

H1: The heel protector is effective in preventing heel pressure ulcer. H0: The heel protector has no effect on preventing heel pressure ulcer. H2: The heel protector is effective in preventing plantar flexion contracture. H0: The heel protector has no effect on preventing plantar flexion contracture. H3: The heel protector is effective in improving the joint range of patients with plantar flexion contracture.

H0: The heel protector has no effect on improving joint range in patients with plantar flexion contracture.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • High-risk patients; patients who were intubated or extubated in the ICU for at least 5 days and received sedation
  • Patients with Braden Pressure Sore Risk Assessment Scale 16 and below
  • Patients with a Ramsey Sedation Scale of 4 and above

排除标准

  • BMI over 30
  • Patients with vascular disease
  • Patients with albumin level below 2.5 mg/dL
  • Patients mobile within 5 days
  • Patients hospitalized with heel pressure ulcer
  • Despite being included in the study, the patient becomes mobile before 15 days
  • Patients with a medical condition that contraindicates the use of heel protectors

结局指标

主要结局

Foot Joint Opening

时间窗: for 14 days

goniometric measurement by the researcher

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kübra Arslan

Master's Student

Maltepe University

研究点 (1)

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