跳至主要内容
临床试验/NCT06691399
NCT06691399招募中不适用

Routine Oral Care Versus Chlorhexidine Oral Care on Incidence of Nosocomial Pneumonia and Oral Health Among Critically Ill Non-intubated Patients With COPD

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Incidence of nosocomial pneumonia

研究概览

简要总结

Poor dental hygiene has been linked to respiratory pathogen colonization in ICU patients. Therefore, respiratory pathogens tend to colonize dental plaque and oral mucosa in these populations. Therefore, strategies to eliminate respiratory pathogens from the oral cavity may improve oral hygiene and decrease the development of nosocomial pneumonia.

详细描述

Infection is a common problem and a major cause of morbidity and mortality for patients in intensive care units (ICUs). Pneumonia is the most common site of infection according to an international study of the prevalence and outcomes of infection in ICUs, which included 13,796 patients. Nosocomial pneumonia (NP) is among the leading causes of mortality in patients in the ICU. Notably, the incidence of nosocomial pneumonia is increasing, and the number of infection-related deaths that follow is also increasing. Thus, preventing nosocomial pneumonia is a cost reducing and life-saving health care practice, especial in ICUs.

Nosocomial pneumonia (NP) was defined as an infection of the lower respiratory tract that does not exist at the time of admission and does not have an incubation period of infection but occurs 48 hours after admission. The most important cause for the development of nosocomial pneumonia is the oral environment. The oral cavity of ICU patients is an important reservoir for bacteria and provides a habitat for microorganisms that can lead to nosocomial pneumonia. Patients in ICUs acquire pneumonia by aspirating oral bacteria that have been colonized in the oral cavity into the lower respiratory tract. Due to advanced age, limited mobility, illness, and cognitive dysfunction, patients in ICUs often have difficulty maintaining oral hygiene by themselves.

Poor dental hygiene has been linked to respiratory pathogen colonization in ICU patients. Therefore, respiratory pathogens tend to colonize dental plaque and oral mucosa in these populations. Therefore, strategies to eliminate respiratory pathogens from the oral cavity may improve oral hygiene and decrease the development of nosocomial pneumonia. The aim of the present study is to assess value of preventive strategy using chlorhexidine for oral care among non-intubated COPD patients admitted to ICU upon incidence of nosocomial pneumonia.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Patients diagnosed as COPD
  • •admitted to ICU with acute exacerbation
  • •need for noninvasive ventilatory support including noninvasive ventilation anf high flow nasal cannula

排除标准

  • •patients refusing to participate
  • •End stage organ failure (Heart Failure, Liver cell failure and/or Renal failure

研究组 & 干预措施

Routine oral care (Group 1)

Placebo Comparator

Group (1) will receive routine oral care twice daily with gauze for cleansing and tooth brushing

干预措施: Oral care (Other)

Chlorhexidine oral care

Active Comparator

Group (1) will receive routine oral care twice daily with gauze for cleansing and tooth brushing plus oral care with chlorohexidine solution (concentration 1.2%)

干预措施: Oral care (Other)

结局指标

主要结局

Incidence of nosocomial pneumonia

时间窗: 1 month

Incidence of nosocomial pneumonia diagnosed via clinical features and confirmed with either chest ultrasonography or chest radiography

次要结局

未报告次要终点

研究者

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

Waleed Gamal Elddin Khaleel

Assistant Professor of Chest Diseases

Assiut University

研究点 (1)

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