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临床试验/NCT07825727
NCT07825727已完成不适用

Evaluation of Pressure Injury Risks in Patients Undergoing Hemofiltration in Intensive Care Units

Ogr. Uyesi Naile1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2025年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
109
试验地点
1
主要终点
Outcome Criterion:

研究概览

简要总结

Purpose: Patients treated in intensive care units are at high risk of developing pressure injuries due to their critical illnesses as well as many risk factors such as immobility, changes in level of consciousness, hemodynamic instability, mechanical ventilation, sedative and vasoactive drug use, nutritional deficiencies and long-term hospitalization. In patients receiving hemofiltration treatment, the long duration of treatment, exposure to medical devices, limitation of movement and the severity of the clinical condition may further increase this risk. Pressure injuries can negatively affect the patient's quality of life, increase the duration of care and health care costs, and lead to significant complications. Therefore, it is important to determine the risks of pressure injuries in intensive care patients receiving hemofiltration at an early stage and to reveal risk-related factors. The aim of this study is to evaluate the risks of pressure injury in patients receiving hemofiltration therapy in the intensive care unit and to determine the clinical and treatment-specific factors associated with the development of pressure injury.

Method: The research was planned as descriptive. The study will be carried out between 15 July 2025 and 1 July 2026 by Prof. Dr. It is planned to be carried out in Süleyman Yalçın City Hospital Anesthesia and Reanimation Intensive Care Unit. The population of the research will consist of patients who will receive hemofiltration treatment in the intensive care unit between the specified dates. The sample size was calculated based on logistic regression analysis using the G*Power 3.1 program; It was determined that a minimum of 109 participants should be reached, taking into account the 5% significance level, over 95% statistical power and OR = 2.5 effect size. Patients who are 18 years of age or older, receive hemofiltration, and are approved to participate in the research by their legal representatives will be included in the study. Patients whose planned intensive care unit stay is less than 48 hours and whose skin integrity is impaired due to special treatments other than hemofiltration will be excluded from the study.

Data will be collected using the Intensive Care Clinical Observation and Patient Information Form created by the researchers, as well as the Glasgow Coma Scale (GCS), Richmond Agitation-Sedation Scale (RASS), APACHE II, Braden Pressure Sore Risk Assessment Scale and Medical Device-Dependent Pressure Sore Risk Assessment Scale. Clinical characteristics of the patients, such as age, gender, height, weight, body mass index, diagnosis and reason for hospitalization, length of stay in the intensive care unit, smoking history, mechanical ventilation status and parameters, diet, frequency of positioning, medications used and paralytic agents will be recorded. In addition, daily blood gas measurements and albumin, hemoglobin, CRP and other relevant laboratory values will be evaluated. Patients' clinical and treatment-related data will be recorded on the first day, last day of hemofiltration and 72 hours after leaving treatment.

Skin integrity and pressure injury development will be evaluated on the first day, last day of hemofiltration and 72 hours after leaving treatment, taking into account EPUAP and NPIAP guidelines. The presence, location, size, stage, infection status and clinical symptoms of the pressure injury will be recorded. General risk of pressure injury by Braden Scale; With the Medical Device-related Pressure Sore Risk Assessment Scale, the risk of pressure injury due to medical devices will be evaluated. Thus, the relationship of variables such as hemofiltration duration, level of consciousness and sedation, disease severity, medical device exposure, positioning frequency, nutritional status and blood parameters with the risk of pressure injury will be examined.

Evaluation of Data: Research data will be analyzed using SPSS 22.0 package program. Descriptive data will be presented as numbers, percentages, mean and standard deviation. Chi-Square and Fisher exact tests will be used to compare categorical variables in independent groups. Logistic regression analysis will be performed to determine the independent factors affecting the development of pressure injury. Statistical significance level will be accepted as p<0.05.

Conclusion: The findings from this study are expected to contribute to the identification of important risk factors for pressure injuries in intensive care patients receiving hemofiltration, the early identification of high-risk patients, and the development of risk-based approaches to prevent pressure injuries in nursing care. It is also thought that the study will contribute to intensive care nursing practices and improving patient safety in terms of evaluating the risk of pressure injury due to medical devices.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

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

  • Being over 18 years of age,
  • Undergoing hemofiltration,
  • Patients whose participation in the study has been approved by their legal representative.

排除标准

  • Planned intensive care unit stay of less than 48 hours,
  • Patients with impaired skin integrity due to different special treatments other than hemofiltration therapy (treatments such as ECMO, VAC, TPN, high-dose vasopressors that impair skin integrity not related to hemofiltration). (These non-hemofiltration-related impairments will be distinguished from the patient's medical history, nursing observation notes, and the opinion of the intensive care specialist. The clinical course in the patient's file will be used to determine the underlying cause.)

研究组 & 干预措施

monitoring

Experimental

干预措施: Identifying the risks of pressure injuries (Other)

结局指标

主要结局

Outcome Criterion:

时间窗: the first day of hemofiltration, the last day, and 72 hours after discontinuation

Changes in pressure injury risk levels among patients undergoing hemofiltration will be examined. The Braden risk assessment tool will be used. The Braden Pressure Injury Risk Assessment Scale comprises six sub-dimensions: sensory perception, activity, mobility, moisture, nutrition, and friction and shear. The total score on the scale ranges from 6 to 23. The risk of developing a pressure injury increases as the score decreases.

次要结局

未报告次要终点

研究者

发起方
Ogr. Uyesi Naile
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ogr. Uyesi Naile

Assistant Prof.

Fenerbahce University

研究点 (1)

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