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临床试验/NCT07365956
NCT07365956已完成不适用

The Effect of Oral Care Using Apple Cider Vinegar, Chlorhexidine Gluconate and Sodium Bicarbonate on Oral Microbial Colonization in Neurosurgery Intensive Care Patients

Harran University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Change From Baseline in Oral Microbial Colonization Levels and Oral Assessment Scale Score

研究概览

简要总结

In the high-stakes environment of the Neurosurgery Intensive Care Unit (NSICU), patient stability extends beyond neurological monitors and intracranial pressure readings. A critical yet often underemphasized front line of defense is oral health. Neurosurgery patients, frequently intubated, on mechanical ventilation, or with depressed consciousness, are at extreme risk for Ventilator-Associated Pneumonia (VAP) and systemic infections. Pathogenic oral microbiota can be aspirated into the lower respiratory tract, triggering such complications. Consequently, rigorous oral care is not merely a comfort measure but a vital infection control protocol. This article examines and compares the effects of three agents-Chlorhexidine Gluconate (CHG), Sodium Bicarbonate, and Apple Cider Vinegar (ACV)-on oral microbial colonization in this vulnerable population.

详细描述

The normal oral flora undergoes a dramatic shift in critically ill patients. Factors like mouth breathing, nil-by-mouth status, decreased salivary flow, and the presence of endotracheal tubes create a pathogenic-friendly environment. This dysbiosis leads to colonization by opportunistic pathogens like Staphylococcus aureus, Pseudomonas aeruginosa, and Candida species. For neurosurgery patients, an ensuing pneumonia can lead to sepsis, increased intracranial pressure from systemic inflammation, prolonged ventilation, and longer ICU stays, directly impacting neurological recovery.

Aim of this study to examine the effect of oral care using ACV, chlorhexidine gluconate and sodium bicarbonate on oral microbial colonization in neurosurgery intensive care patients.

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
None

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

  • Mechanical ventilation was initiated less than 24 hours ago,
  • Aged 18 years or older,
  • Had not undergone any oral surgical procedure,
  • Were not leukopenic or thrombocytopenic,
  • And had no oral infection such as aphthous ulcer, stomatitis, or gingivitis.

排除标准

  • Mechanical ventilation was initiated more than 24 hours ago,
  • Under 18 years of age,
  • Had undergone any oral surgical procedure,
  • Were leukopenic or thrombocytopenic,
  • Or had an oral infection such as aphthous ulcer, stomatitis, or gingivitis.

研究组 & 干预措施

Chlorhexidine Gluconate Group

Experimental

Before Oral Care:

The Patient Identification Form was filled out. The Oral Assessment Scale was applied. An oral culture sample was obtained.

Procedure:

Participants receive oral care using chlorhexidine gluconate solution every 6 hours for 5 days in the neurosurgical intensive care unit..

The Oral Assessment Scale was applied. On the final day (Day 5), an oral culture sample was obtained.

干预措施: Chlorhexidine gluconate (CHG) (Drug)

Sodium Bicarbonate Group

Experimental

Before Oral Care: The Patient Identification Form was filled out. The Oral Assessment Scale was applied. An oral culture sample was obtained. Procedure: Participants receive oral care using sodium bicarbonate solution every 6 hours for 5 days in the neurosurgical intensive care unit. The Oral Assessment Scale was applied. On the final day (Day 5), an oral culture sample was obtained.

干预措施: Sodium Bicarbonate (NaHCO3) (Drug)

Apple Cider Vinegar Group

Experimental

Before Oral Care: The Patient Identification Form was filled out. The Oral Assessment Scale was applied. An oral culture sample was obtained. Procedure: Participants receive oral care using apple cider vinegar solution every 6 hours for 5 days in the neurosurgical intensive care unit. The Oral Assessment Scale was applied. On the final day (Day 5), an oral culture sample was obtained.

干预措施: Apple Cider Vinegar (Other)

结局指标

主要结局

Change From Baseline in Oral Microbial Colonization Levels and Oral Assessment Scale Score

时间窗: Day 0 to Day 5

Oral microbial colonization will be measured using quantitative culture analysis of oral swab samples. Results will be reported as colony-forming units (CFU). The primary outcome is the change in CFU values from baseline (Day 0) to Day 5 following the oral care intervention. Oral mucosal condition will be measured using the Oral Assessment Scale. Scores will be recorded at baseline (Day 0) and on Day 5. The outcome will be reported as the change in total scale score between the two time points. All outcome measurements were completed within the first 5 days following initiation of the oral care intervention.

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

MURAT TAMER

Assistant Professor

Harran University

研究点 (1)

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