The Efficacy of Adjuvant Oral Care in Prevention of Ventilator Associated Pneumonia: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Incidence of Ventilator-Associated Pneumonia (VAP)
研究概览
简要总结
A Randomized Controlled Trial (RCT) at Services Hospital, Lahore, aims to reduce Ventilator-Associated Pneumonia (VAP) incidence and mortality rates while shortening ICU stays in mechanically ventilated patients by adding adjuvant oral care to traditional practices.
Study Objectives:
Focus: ICU patients on mechanical ventilation. Question: Does adjuvant oral care reduce VAP rates and ICU stays?
Methodology:
Sample: Minimum 100 eligible subjects via convenient sampling. Randomization: Computer software for unbiased group allocation. Interventions: Intervention group gets Chlorhexidine mouthwash, toothbrushing, and oral gel; control group gets 0.2% Chlorhexidine mouthwash.
Measures: Evaluate VAP using Modified Clinical Pulmonary Infection Score (MCPIS) and compare demographic data.
Statistical Analysis: SPSS v22 to analyze data.
Expected Impact:
Potential to reduce VAP and improve ICU patient outcomes. Cost-effective treatment with adjuvant oral care. Shorter ICU stays, relieving VAP burden. Enhanced patient care, reduced mortality, and resource strain. Aligns with reducing VAP incidence and improving ICU patient care.
详细描述
The study in question is a Randomized Controlled Trial (RCT) conducted at Services Hospital, Lahore, over a three-month duration. It aims to assess the effects of including adjuvant oral care as part of traditional oral care in reducing the incidence and mortality rates of Ventilator-Associated Pneumonia (VAP) while also shortening the length of ICU stays among patients on mechanical ventilation. This research holds the potential to bring significant improvements to patient care and reduce the burden of VAP in critical care settings.
Study Objectives:
Population Focus: The study focuses on patients admitted to the intensive care unit (ICU) who are receiving mechanical ventilation.
Research Question: The central question this study seeks to answer is: Does the inclusion of adjuvant oral care alongside traditional oral care reduce the incidence and mortality rates of VAP and shorten the length of ICU stay among patients on mechanical ventilation?
Methodology:
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU patients on intensive mechanical ventilation aged 18-65 years of either sex with oral ETT in situ.
- •MCPIS score between 0 to 5 on first day of admission at ICU
排除标准
- •More than 48 hours of mechanical ventilation before ICU admission.
- •Previous history of respiratory illness.
- •Immunocompromised.
- •Ongoing sepsis.
- •Pregnancy.
- •Presence of dentures.
研究组 & 干预措施
(Adjuvant Oral Care) Intervention Group
This group represents the intervention arm of the study. Patients in this arm receive a combination of interventions, including Chlorhexidine mouthwash, toothbrushing, and the application of moisturizing gel on the interior and exterior surfaces of the oral cavity. This group is the focus of the study's investigation to determine the effectiveness of adjuvant oral care in reducing the incidence of Ventilator-Associated Pneumonia (VAP) and improving patient outcomes.
干预措施: Comprehensive Oral Care (Procedure)
(Adjuvant Oral Care) Intervention Group
This group represents the intervention arm of the study. Patients in this arm receive a combination of interventions, including Chlorhexidine mouthwash, toothbrushing, and the application of moisturizing gel on the interior and exterior surfaces of the oral cavity. This group is the focus of the study's investigation to determine the effectiveness of adjuvant oral care in reducing the incidence of Ventilator-Associated Pneumonia (VAP) and improving patient outcomes.
干预措施: Mechanical Tooth Brushing using 0.2% Chlorhexidine (Device)
(Adjuvant Oral Care) Intervention Group
This group represents the intervention arm of the study. Patients in this arm receive a combination of interventions, including Chlorhexidine mouthwash, toothbrushing, and the application of moisturizing gel on the interior and exterior surfaces of the oral cavity. This group is the focus of the study's investigation to determine the effectiveness of adjuvant oral care in reducing the incidence of Ventilator-Associated Pneumonia (VAP) and improving patient outcomes.
干预措施: Moisturizing Gel (Device)
(Traditional Oral Care) Control Group
This group represents the control arm of the study. Patients in this arm receive traditional oral care, which involves the use of 0.2% Chlorhexidine mouthwash only.
干预措施: Traditional Oral Care (Procedure)
(Traditional Oral Care) Control Group
This group represents the control arm of the study. Patients in this arm receive traditional oral care, which involves the use of 0.2% Chlorhexidine mouthwash only.
干预措施: Oral care using Cotton swab dipped in 0.2% Chlorhexidine (Device)
结局指标
主要结局
Incidence of Ventilator-Associated Pneumonia (VAP)
时间窗: Five days after initiation of the assigned oral care intervention.
This outcome measures the number of participants who developed ventilator-associated pneumonia (VAP) within the early period following initiation of mechanical ventilation. VAP was assessed using clinical and diagnostic criteria on the fifth day after implementation of the assigned oral care intervention. This outcome was used to evaluate the effectiveness of adjuvant oral care compared with traditional oral care in preventing early-onset VAP.
次要结局
- Mortality Rates(These demographic characteristics and clinical parameters will be assessed throughout the three-month duration of the study at Services Hospital, Lahore.)
- Duration of ICU Stay(These demographic characteristics and clinical parameters will be assessed throughout the three-month duration of the study at Services Hospital, Lahore.)
研究者
Akash Samuel
Principal Investigator
University of Health Sciences Lahore