跳至主要内容
临床试验/NCT05480254
NCT05480254Unknown不适用

The Effect on Catheter-Related Complıcatıons of Clamping Method the Indwelling Urinary Catheters in ICU Patıents: A Randomızed Controlled Trial

Hulya Kocyigit1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2021年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
110
试验地点
1
主要终点
Enfectious complications

研究概览

简要总结

Background: Bladder training through catheter clamping is an important nursing practice. There is no clear information and sufficient evidence for catheter clamping in bladder training before urinary catheter removal in guidelines for clinical practice.

Objective: To evaluate the results of bladder training in ICU patients. Design: Randomized controlled trial. Setting general surgery ıntensıve care. Methods: Patients were randomly assigned either to have their urinary catheter clamped before removal or to have their catheter removed with free drainage.. Patients who will continue to have urinary catheterization for at least 5 days were included in the study.

Results: - Conclusion: -

详细描述

Nurses are key professionals in the prevention of complications associated with indwelling urinary catheterization in the hospital setting. In this context, bladder training through catheter clamping is an important nursing practice. Indwelling catheter clamping in bladder training was first proposed by Ross in 1936. There is no clear information and sufficient evidence for catheter clamping in bladder training before urinary catheter removal in national and international guidelines for clinical practice.

In a study by Williamson (1982) on this subject, it was reported that intermittent clamping before removal of the indwelling urinary catheter reduces the frequency of urinary retention and shortens the time to return to normal bladder function. However, a systematic review published in Cochrane (2007) on strategies for removal of short-term indwelling urethral catheters in adults found insufficient evidence to suggest that catheter clamping prior to termination of catheterization is effective to induce normal bladder filling. In another systematic review published in Cochrane (2016), there was no significant difference between the patients' subjective perceptions of recatheterization, urinary retention, catheter-related urinary tract infection and urination symptoms in the clamping and free drainage groups.

In the limited number of studies on bladder training performed by clamping the indwelling urinary catheter, no evidence for practice could be obtained, and there is no consensus among clinicians yet. Ultimately, more research, better quality methodology, and more diverse study designs are needed until strong evidence is available to remove this uncertainty.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

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

入选标准

  • •Glasgow Coma Scale between 13-15 when clamping will be performed.
  • •Within the first 12 hours of admission to the intensive care unit,
  • •Will continue urinary catheterization for at least 5 days,
  • •No diagnosed or recurrent urinary tract infection,
  • •Patients who agreed to participate in the study by obtaining their informed consent and who will not leave the study during the study.

排除标准

  • •Having urinary outflow resistance/difficulty (prostate enlargement, urethral stenosis, etc.),
  • •Those who have suprapubic catheters or who will undergo intermittent catheterization,
  • •Patients with impaired nerve conduction,
  • •Patients taking anticholinergic drug therapy such as tricyclic antidepressants,
  • •Patients receiving sympathomimetric drug therapy,
  • •Having a neurogenic bladder,
  • •Having diabetic cystopathy, Have a previous history of urinary retention or urination dysfunction,

研究组 & 干预措施

clamped catheter group

Experimental

Q3 clamped catheter protocol is applied before urinary catheter removal

干预措施: clamped catheter (Other)

free dranaige group

No Intervention

Free dranaige is applied before urinary catheter removal

结局指标

主要结局

Enfectious complications

时间窗: 1-5 days

Catheter-Related Infectious Complications Follow-up Form

次要结局

  • Other complications(6. days 1-12 hour between)

研究者

发起方
Hulya Kocyigit
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hulya Kocyigit

Principal Investigator

Cumhuriyet University

研究点 (1)

Loading locations...

相似试验