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临床试验/NCT05877105
NCT05877105已完成不适用

Effect of Selected Evidence-based Practices and Related Nurses' Education on the Incidence and Severity of Ventilator-associated Pneumonia

Cairo University2 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2023年5月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
99
试验地点
2
主要终点
Evaluate the effect of the selected EPB and related nurses' education on the incidence VAP

研究概览

简要总结

Background:

Invasive mechanical ventilation (MV) is used as a cornerstone in the treatment plan of intensive care units (ICUs) patients to provide adequate tissue oxygenation to support the body during the treatment course.

Ventilator-associated pneumonia (VAP) is a preventable iatrogenic complication that can develop in patients undergoing mechanical ventilation. VAP is pneumonia that develops 2 days after endotracheal intubation; the patient must have new or progressive radiological infiltrate, infection alerts (e.g. fever, white blood cell count change), altered sputum characters, and isolation of a causative organism, all together to diagnose VAP. VAP is the most frequent hospital-acquired infection occurring in the ICUs and has a high associated mortality rate. Mortality rate for VAP ranges from 24-51%.

Therefore, this study aims to evaluate the VAP preventive effect of the selected EPB and related nurses' education on the incidence and severity of VAP, as well as assess the nurses' compliance with the selected VAP preventive EBP

Hypothesis:

H1: Implementation of VAP prevention EBP and related nurses' education would reduce the incidence of VAP among mechanically ventilated patients compared to those receiving conventional care.

H2: Implementation of VAP prevention EBP and related nurses' education would reduce the severity of VAP among mechanically ventilated patients compared to those receiving conventional care.

Research question:

Q1: What level of compliance do ICU staff have with implementing of VAP prevention EBP?

Trial design The current study will utilize a prospective, longitudinal, single-arm design, pre & post-experimental. The research's purpose, risks, and potential benefits will be explained to all participants before their voluntary consent and recruitment into the study. Participation was completely voluntary, and written informed consent was obtained from all participants or their families.

ICU nurses will receive tutorial sessions, including four hours of theory and six hours of clinical training in the clinical setting. The tutorial sessions will cover the proper implementation of ten VAP preventive bundles as an EVB. The clinical training will use a demonstration and redemonstration approach to learning to ensure that they understand and can implement the ten VAP preventive bundles efficiently.

Participants sample and setting The study will be held at the ICU of the National Hepatology and Tropical Medicine Research Institute (Imbaba Fever Hospital) (NHTMRI-IFH), Giza, Egypt. The total capacity of the ICUs is 20 beds.

Data collection procedure After obtaining ethical and administrative approval, informed consent will be obtained from eligible patients. The pre-experimental phase will be started by assessing VAP incidence and severity among the participating MV patients using tools 1 and 2, as well as ICU staff compliance to implement the VAP preventive bundle utilizing tool 3 as baseline data for 30-40 days. After finishing the pre-assessment, the following week will be considered washing time before starting the post-experimental time to ensure that all pre-assessment patients are discharged. During the washing time, the nurses will receive a tutorial session on how to implement the adopted VAP preventive bundle, and then the medical and nursing staff will start implementing the VAP preventive bundle in the post-experimental phase for 30-40 days. Tools 1, 2, and 3 will be utilized to evaluate VAP incidence, severity, and ICU staff compliance to implement the VAP preventive bundle. All data will be collected in an Excel sheet for potential statistical analysis.

详细描述

Background:

Invasive mechanical ventilation (MV) is used as a cornerstone in the treatment plan of intensive care units (ICUs) patients to provide adequate tissue oxygenation to support the body during the treatment course.

Ventilator-associated pneumonia (VAP) is a preventable iatrogenic complication that can develop in patients undergoing mechanical ventilation. VAP is pneumonia that develops 2 days after endotracheal intubation; the patient must have new or progressive radiological infiltrate, infection alerts (e.g. fever, white blood cell count change), altered sputum characters, and isolation of a causative organism, all together to diagnose VAP. VAP is the most frequent hospital-acquired infection occurring in the ICUs and has a high associated mortality rate. Mortality rate for VAP ranges from 24-51%.

Therefore, this study aims to evaluate the VAP preventive effect of the selected EPB and related nurses' education on the incidence and severity of VAP, as well as assess the nurses' compliance with the selected VAP preventive EBP

Hypothesis:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • ICU patients intubated mechanical ventilation for more than 48 hours
  • Also, the ICU staff (medical or nurses) working in the selected ICU will be invited to participate in this study to learn and implement the ten VAP preventive bundles.

排除标准

  • Patients intubated outside the IFH.
  • patients have immunocompromised diseases will be excluded.

结局指标

主要结局

Evaluate the effect of the selected EPB and related nurses' education on the incidence VAP

时间窗: 35-40 days

VAP incidence will be measured using the diagnostic criteria for clinically defined pneumonia outlined by the Centres for Disease Control and Prevention of the United States (TOOL 1) \[3\]. The ICU specialist will made a final diagnosis of VAP based on chest imaging test results, clinical signs/symptoms, and laboratory findings. VAP incidence will be measured every day for MV patients using tool 1.

次要结局

  • Evaluate the effect of the selected EPB and related nurses' education on the severity of VAP(35-40 days)
  • Assess the compliance of ICU staff with implementing VAP prevention bundel as an EBP(35-40 days)

研究者

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

Sameh Elhabashy

lecturer

Cairo University

研究点 (2)

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