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临床试验/NCT05521659
NCT05521659已完成不适用

A Systematic Oral Care Protocol in Non-Mechanically Ventilated Stroke Patients

Istanbul University - Cerrahpasa (IUC)1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
the number of bacteria variable

研究概览

简要总结

This study was conducted to examine the effect of a systematic oral care protocol on bacterial colonization of the oral mucosa in non-mechanically ventilated stroke patients. This experimental study was conducted in Bakirkoy Prof. Dr. Mazhar Osman Research and Training Hospital for Psychiatry, Neurology and Neurosurgery between January -June 2020. The research was carried out with 42 stroke patients who were hospitalized in the intensive care unit but not underwent mechanical ventilation. A standardized oral care protocol was developed and applied to the patients in the experimental group three times a day. The control group underwent non-standardized oral care, which is available in the routine practice of the clinic. Two groups were compared at baseline and at the 5th day of hospital stay in terms of bacterial colonization, oral cavity and complications.

详细描述

This experimental study was conducted in Bakirkoy Prof. Dr. Mazhar Osman Research and Training Hospital for Psychiatry, Neurology and Neurosurgery between January -June 2020. The research was carried out with 42 stroke patients who were hospitalized in the intensive care unit but not underwent mechanical ventilation. A standardized oral care protocol was developed and applied to the patients in the experimental group three times (at 06:00, 14:00, 22:00) a day (with use of an oral hygiene kit including chlorhexidin gluconate). The control group underwent usual care (oral care with use of the same kit but applied twice a day without following a protocol). Two groups were compared at baseline and at the 5th day of hospital stay in terms of bacterial colonization, oral cavity (by use of Oral Assessment Guide) and complications.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having a diagnosis of stroke,
  • Being not connected to a mechanical ventilator (patients who were on spontaneous breathing or receiving oxygen support with a mask or nasal cannula),
  • Having at least 3 teeth, and
  • Cannot meet the need for oral care.

排除标准

  • Patients who were intubated or tracheostomized were excluded.

结局指标

主要结局

the number of bacteria variable

时间窗: 5 days.

The number of bacteria in the oral mucosa of stroke patients who are given oral care according to the standardized oral care protocol after the intervention will be less than the pre-intervention and control groups.

次要结局

  • oral evaluation scale variable(Evaluation will be done at the beginning of the study and at the end of the 5th day.)
  • the type of bacteria variable(Evaluation will be done at the beginning of the study and at the end of the 5th day.)

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeliha Tülek

Assoc.Prof

Istanbul University - Cerrahpasa (IUC)

研究点 (1)

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