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临床试验/NCT06258603
NCT06258603已完成不适用

The Effect of Oral Care Bundle Application on Salivary pH (Power of Hydrogen), Dry Mouth and Ventilator-associated Pneumonia in Intubated Patients

Nigde Omer Halisdemir University2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2019年5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
35
试验地点
2
主要终点
Individual Identification Form

研究概览

简要总结

The aim of the research was to examine the effect of oral care bundle application on oral health, salivary pH (power of hydrogen), dry mouth and ventilator associated pneumonia in intubated patients compared to standard oral care.

详细描述

Maintaining the integrity of the oral mucosa in intensive care unit patients is very important due to its close relationship with systemic health, disease risk and self-image, as well as comfort and nutrition. Serious problems develop in patients who have no or insufficient saliva movement or production, are unconscious, or have an artificial airway. Oral health problems, which begin with the deterioration of the saliva flow and content of intubated patients, lead to much more risky and costly situations that end in ventilator associated pneumonia. In the literature, it is seen that oral care practices performed in accordance with protocols increase the risk of complications and that bundle care practices used in different care areas increase the performance of care.In this randomized controlled study, people who were aged between 18 and 70, had received mechanical ventilation support, were intubated orally and in the first 24 hours of intubation, and had a stable hemodynamic status were included in the study.

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)

盲法说明

Single Blinded

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • mechanical ventilation support,
  • orally intubation
  • in the first 24 hours of intubation,
  • stable hemodynamic status

排除标准

  • pneumonia
  • Sjögren's Syndrome,
  • radiotherapy and/or chemotherapy,
  • oral care contraindications,
  • head and neck trauma,
  • platelet count below 50 thousand,
  • could not be positioned appropriately,
  • agitation

结局指标

主要结局

Individual Identification Form

时间窗: First day of data collection

The form was prepared by the researcher in line with literature information. It consists of 9 questions covering the characteristics of the patients (demographic characteristics, diagnoses, APACHE II scores, Glasgow Coma Scale score, rules, feeding patterns, intubation tube number).

In this outcome measure, the patients' saliva amount was evaluated.

时间窗: The 1st, 3rd and 5th days of oral care practices.

Schirmer Tear Test Strip was used in the application. The Modified Schirmer Test strip was placed under the tongue by holding its end with forceps, and after waiting for 3 minutes, the mm value of the wetness on the strip was read.

In this outcome measure, it was evaluated whether ventilator-associated pneumonia occured in patients receiving care.

时间窗: Evaluated for five days.

To avoid bias regarding the method used, the diagnosis of ventilator associated pneumonia was made independently by the treatment team. In the Intensive Care Unit of Ege University Faculty of Medicine, Department of Anesthesiology and Reanimation, the diagnosis of ventilator associated pneumonia is made by the physician using the nosocomial infection diagnostic criteria of The Centers for Disease Control and Prevention (CDC). Information about the development of ventilator associated pneumonia was obtained from the infection control nurse.

Bedside Oral Exam Scale

时间窗: Evaluated for five days.

Oral health was assessed using the scale. The scale consists of 8 subheadings (swallowing, lips, tongue, saliva, mucous membranes, gums, teeth or dentures, and smell). The scale score ranges from 8 points (perfect oral health) to 24 points (impaired oral health).

In this outcome measure, the patients'vsaliva pH (power of hydrogen) was evaluated.

时间窗: The 1st, 3rd and 5th days of oral care practices

Merck brand Universal pH 0-14 indicator was used to measure the saliva pH of the patients. The indicator was placed on the tongue and waited for 1 minute, and the resulting color change was compared with the color scale on the box. According to the literature, the average pH of unstimulated saliva has been determined to be approximately 6.8.

次要结局

未报告次要终点

研究者

发起方
Nigde Omer Halisdemir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gül Güneş AKTAN

Principal Investigator

Nigde Omer Halisdemir University

研究点 (2)

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