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Oral Care Frequency in Mechanically Ventilated Patients

2022年7月18日 更新者:Aslıhan Tahtali Turgut、Aydin Adnan Menderes University

The Effect of Oral Care Frequency on Oral Mucosa Membrane Integrity in Patients With Mechanical Ventilation Support

Many problems may develop in patients due to mechanical ventilation in intensive care units. These include ventilator-associated pneumonia, decreased cerebral perfusion, venous air embolism, sinus and eye infections, neuromuscular dysfunctions and skin sores may be seen in intensive care patients undergoing mechanical ventilation. If adequate oral hygiene is not provided in patients on mechanical ventilation support, dry mouth, halitosis, disruption of tissue integrity in and around the mouth, intraoral infections and periodontal diseases may occur. Most importantly, ventilator-associated pneumonia (VIP) may develop in patients dependent on mechanical ventilation due to deficient oral care.

Chlorhexidine solution is widely used in oral care. However, there is a need for evidence about the frequency of oral care with which chlorhexidine solution on oral mucous membrane integrity in patients under mechanical ventilation support. Oral care frequency was not examined in these existing studies. Therefore, this study was planned to determine the effect of three different oral care frequencies on the integrity of the oral mucous membrane in patients connected to mechanical ventilators.

研究概览

地位

完全的

详细说明

Oral hygiene is one of the applications where the individual needs the most hygienic care. Providing oral care and maintaining oral hygiene improves the comfort and quality of life by ensuring that the individual eats healthy and feels well.Inadequate oral care can negatively affect all these, as well as cause problems such as dry mouth, dental caries, periodontal diseases, bad breath and stomatitis.Therefore, in order to maintain oral health, individuals must perform oral care effectively.

Nurses need to have adequate oral intake to maintain the integrity of the oral mucosa, especially in patients who cannot be fed orally, with fluid restriction, administered nasogastric tube, mouth breathing, receiving oxygen therapy, undergoing oral and maxillofacial surgery, undergoing radiation therapy, chemotherapy, in the terminal period, in coma, and in patients dependent on mechanical ventilator. care must be provided.

Defense mechanisms in intensive care patients are affected by their disease and multiple interventions that circumvent natural host defenses. Treatments applied in intensive care units, lack of fluid intake of the patient, and some materials used for treatment and care cause changes in the oral mucous membrane. Inadequate protective mechanisms in patients can lead to both local and systemic complications such as caries, periodontal disease, oral mucosal infections, and ventilator-associated pneumonia.

Bacterial oropharyngeal colonization progressively changes to tracheal colonization leading to ventilator-associated pneumonia.

Especially in patients connected to mechanical ventilators, the entry of bacteria into the respiratory tract is facilitated and increased due to the endotracheal tube, causing the coughing reflex and mucociliar activity to be impaired and secretion to increase. In this case, gram-positive bacteria that make up the normal flora in the oral mucosa are replaced by gram-negative bacteria, causing changes in the oral flora and plaque formation on the teeth. Therefore, oral care becomes much more important.The solution and frequency to be used gain importance for oral care to be effective on the integrity of the oral mucous membrane.

In the literature, it is recommended to use chlorhexidine gluconate solution in oral care to prevent the development of ventilator-associated pneumonia in mechanically ventilated patients.However, there is no evidence on how often oral care should be performed.

When the literature is reviewed, further studies with conclusive evidence to show how often chlorhexidine gluconate is effective are needed. For this reason, this study was planned to determine the effect of three different oral care frequencies on the integrity of the oral mucous membrane in patients dependent on mechanical ventilators.

The research is planned to be carried out between 01.06.2021 and 01.06.2022 in the internal medicine intensive care unit of Aydın Adnan Menderes University Practice and Research Hospital.

The population of the research is the patients hospitalized in the Internal Medicine intensive care unit of Aydın Adnan Menderes University Practice and Research Hospital between 01.06.2021 and 01.06.2022, and the sample is; Patients who are older than 18 years of age, who are in the first 24 hours of mechanical ventilation, who are 18 years of age and older, and whose relatives have consented. The sample of the research; Patients with thrombocytopenia, leukopenia and oral aphthae, stomatitis, candiasis, gingivitis who have had an oral surgical procedure will not be accepted.

Before starting the practice in this study, the purpose of the research will be explained to all nurses working in the unit by the researchers and an information meeting about oral care will be held. After the operability of the guide in the intensive care unit is ensured, the data collection phase will begin. Randomization of patients will be done by the nurse in charge of the service.

The frequency of oral care of the patients will be in three groups. Oral care will be done twice a day for the patients in the first group, 3 times a day for the patients in the second group, and 4 times a day for the patients in the third group. Oral care of the patients will be applied according to the guide used in the training given to the nurses. In oral care, 0.12% chlorhexidine solution will be used.

The concentration of 0.12% of the chlorhexidine gluconate solution planned to be used in the research is the most frequently used form compared to the other concentrations of the solution. And no side effects were noted in the studies.

For this reason, 0.12% chlorhexidine solution was preferred. When the literature is examined, this density was preferred because it is the most frequently used solution in the oral care of patients under mechanical ventilation support.

The oral mucosa of the patients will be evaluated with the Oral Evaluation Scale by the researcher before the first oral care application every morning for four days. According to the score obtained from the scale, the researcher will evaluate the patients as normal oral mucosa, mild dysfunction, moderate dysfunction and severe dysfunction.

研究类型

介入性

注册 (实际的)

98

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Efeler
      • Aydın、Efeler、火鸡、09100
        • Aydın Adnan Menderes University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • who are over 18 years old,
  • In the first 24 hours of mechanical ventilation,
  • It will consist of patients with consent from their relatives.

Exclusion Criteria:

  • Surgery for the mouth,
  • Patients with oral aphthae, stomatitis, candiasis, gingivitis will not be taken.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:顺序分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:first group
The patients in the first group will be given oral care with 0.12% chlorhexidine twice a day.
The population of the research is the patients hospitalized in the Internal Medicine intensive care unit of Aydın Adnan Menderes University Practice and Research Hospital between 01.06.2021 and 01.06.2022, and the sample is; Patients who are older than 18 years of age, who are in the first 24 hours of mechanical ventilation, who are 18 years of age and older, and whose relatives have consented.Oral care of the patients will be done with 0.12% chlorhexidine solution, and the frequency of oral care will be in three groups. Oral care will be done twice a day for the patients in the first group, 3 times a day for the patients in the second group, and 4 times a day for the patients in the third group. Oral care of the patients will be applied according to the guide used in the training given to the nurses.
实验性的:second group
The patients in the second group will be given oral care with 0.12% chlorhexidine 3 times a day.
The population of the research is the patients hospitalized in the Internal Medicine intensive care unit of Aydın Adnan Menderes University Practice and Research Hospital between 01.06.2021 and 01.06.2022, and the sample is; Patients who are older than 18 years of age, who are in the first 24 hours of mechanical ventilation, who are 18 years of age and older, and whose relatives have consented.Oral care of the patients will be done with 0.12% chlorhexidine solution, and the frequency of oral care will be in three groups. Oral care will be done twice a day for the patients in the first group, 3 times a day for the patients in the second group, and 4 times a day for the patients in the third group. Oral care of the patients will be applied according to the guide used in the training given to the nurses.
实验性的:third group
The patients in the third group will be given oral care with 0.12% chlorhexidine 4 times a day.
The population of the research is the patients hospitalized in the Internal Medicine intensive care unit of Aydın Adnan Menderes University Practice and Research Hospital between 01.06.2021 and 01.06.2022, and the sample is; Patients who are older than 18 years of age, who are in the first 24 hours of mechanical ventilation, who are 18 years of age and older, and whose relatives have consented.Oral care of the patients will be done with 0.12% chlorhexidine solution, and the frequency of oral care will be in three groups. Oral care will be done twice a day for the patients in the first group, 3 times a day for the patients in the second group, and 4 times a day for the patients in the third group. Oral care of the patients will be applied according to the guide used in the training given to the nurses.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Oral mucosal evaluation of patients.
大体时间:Oral care is given to patient groups 2 times a day, 3 times a day, 4 times a day for 4 days. Evaluation will be done at the beginning of the study and every day for 4 days.
The oral mucosa of the patients will be evaluated with the Eilers Mouth Rating Scale.
Oral care is given to patient groups 2 times a day, 3 times a day, 4 times a day for 4 days. Evaluation will be done at the beginning of the study and every day for 4 days.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Gülengün Türk, Prof.Dr、Aydın Adnan Menderes University, Faculty of Nursing, Department of Nursing Fundamentals

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年7月5日

初级完成 (实际的)

2022年6月1日

研究完成 (实际的)

2022年7月1日

研究注册日期

首次提交

2021年7月2日

首先提交符合 QC 标准的

2021年9月8日

首次发布 (实际的)

2021年9月9日

研究记录更新

最后更新发布 (实际的)

2022年7月20日

上次提交的符合 QC 标准的更新

2022年7月18日

最后验证

2022年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • Oral Care Frequency

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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