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临床试验/CTRI/2022/03/041128
CTRI/2022/03/041128尚未招募不适用

Effect of oral care protocol with versus without chlorhexidine on mortality of mechanically ventilated patients: prospective randomized controlled trial.

Lok Nayak Hospital Jawaharlal Nehru Marg Near Delhi Gate New Delhi D1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2022年3月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
154
试验地点
1
主要终点
Patient outcome (all cause mortality)

研究概览

简要总结

In this study , we aim to assess the effects of oral care protocol  using  a suction tooth brush  for oral care in mechanically ventilated patients and compare this with 0.12% chlorhexidine solution .A total of 154 patients will be recruited for participation in study and they will be randomized into two groups. As per group allocation either suction toothbrush or chlorhexidine will be used for oral care in mechanically ventilated patients.In both the groups other oral care elements such as assessment of oral hygiene, suctioning of oropharyngeal secretions, application of lip and mouth moisturization will be followed. We will be assessing study groups in terms of mortality rate, incidence of VAP ,oral health status

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •All adult patients receiving invasive mechanical ventilation for more than 48 hours.

排除标准

  • •Pulmonary infection at the time of ICU admission 2.Edentulous patients 3.Intraoral surgery or trauma
  • •Pregnant patients
  • •Chlorhexidine allergy.

结局指标

主要结局

Patient outcome (all cause mortality)

时间窗: 5,10 and 15 days after randomization into study

次要结局

  • APACHE II Score(5, 10 and 15 days after randomization)
  • Oral health using BOAS scale and plaque index(5, 10 and 15 days after randomization)
  • Number of days spent on mechanical ventilation(5, 10 and 15 days after randomization)
  • Occurence of ventilator associated pneumonia(5, 10, 15 days after randomization of grooups)

研究者

发起方
Lok Nayak Hospital Jawaharlal Nehru Marg Near Delhi Gate New Delhi D
申办方类型
Government medical college

研究点 (1)

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