Effectiveness of Oropharyngeal Suctioning in Preventing Ventilator-Associated Pneumonia: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- incidence of early-onset Ventilator-Associated Pneumonia (VAP) in mechanically ventilated ICU patients.
研究概览
简要总结
Ventilator-Associated Pneumonia (VAP) is a serious infection that affects patients who are on mechanical ventilation in intensive care units (ICUs). It can increase the risk of death, prolong hospital stays, and lead to higher healthcare costs. This study is designed to evaluate the effectiveness of scheduled oropharyngeal suctioning (removal of secretions from the mouth and throat) every 4 hours in preventing early-onset VAP in ICU patients who require mechanical ventilation for more than 48 hours.
The study will compare two groups of ICU patients: one group will receive scheduled oropharyngeal suctioning every 4 hours in addition to standard oral care, while the other group will receive only standard oral care. The main goal of the study is to determine whether regular suctioning reduces the incidence of VAP, improves patient recovery, and shortens the duration of mechanical ventilation.
This research will help clarify whether adding scheduled suctioning to standard care can prevent VAP and improve clinical outcomes for critically ill patients, potentially leading to better practices in ICU care.
详细描述
Ventilator-Associated Pneumonia (VAP) is a major healthcare concern in intensive care units (ICUs), affecting patients who require mechanical ventilation. VAP typically develops more than 48 hours after intubation and is caused by the aspiration of contaminated oropharyngeal secretions into the lungs. This infection is associated with increased morbidity, prolonged ICU stays, and higher mortality rates. The incidence of early-onset VAP (developing within the first 4-5 days of ventilation) is particularly concerning due to its association with more virulent pathogens and higher mortality rates. Despite the implementation of preventive measures, early-onset VAP continues to be a significant clinical challenge, necessitating the exploration of more effective interventions.
The primary aim of this study is to assess the effectiveness of scheduled oropharyngeal suctioning every 4 hours in preventing early-onset VAP in mechanically ventilated ICU patients. Oropharyngeal suctioning, which involves the mechanical removal of secretions from the mouth and throat, is a standard procedure in many ICUs to maintain airway patency. However, its role in preventing VAP, especially when performed at fixed intervals, has not been conclusively established. While previous studies have suggested that oropharyngeal suctioning may reduce VAP risk, the optimal frequency and protocol remain unclear.
This study will be conducted as a randomized controlled trial (RCT) at the Institute of Nursing, University of Health Sciences, Lahore, in collaboration with Jinnah Hospital, Lahore. The study will include 100 ICU patients who are expected to be mechanically ventilated for more than 48 hours. The patients will be randomly assigned to two groups:
Intervention Group: Scheduled oropharyngeal suctioning every 4 hours, in addition to routine oral care.
Control Group: Standard oral care, including twice-daily brushing of teeth, gums, and tongue, and on-demand suctioning based on clinical indications.
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 aged 18-75 years.
- •Patients expected to require invasive mechanical ventilation for more than 48 hours.
- •Modified Clinical Pulmonary Infection Score (MCPIS) ≤ 5 on Day 1, indicating no or minimal signs of infection.
- •Ability to comply with the study protocol, including informed consent from patient attendants.
排除标准
- •Patients with chronic respiratory diseases (e.g., COPD, asthma).
- •Immunocompromised patients (e.g., those with cancer, organ transplant recipients, or on immunosuppressive therapy).
- •Patients with ongoing sepsis or severe infections at the time of enrollment.
- •Patients who have been on mechanical ventilation for more than 48 hours at the time of ICU admission.
- •Pregnant patients or those unable to comply with the study protocol.
- •Patients with dental prosthetics or dentures, as these may interfere with the suctioning process.
研究组 & 干预措施
Standard Oral Care (Twice-Daily Brushing)
Participants in this group will receive standard oral care as part of ICU routine practice. This includes brushing of teeth, gums, and tongue twice a day to clear accumulated secretions and reduce bacterial growth. Additionally, on-demand suctioning will be performed if clinically indicated (e.g., when visible secretions or discomfort are observed). The control group will not receive the scheduled 4-hourly suctioning intervention, serving as a comparison to evaluate the effectiveness of regular suctioning in preventing VAP.
干预措施: Standard Oral Care (Twice-Daily Brushing) (Procedure)
Participants in this group will receive scheduled oropharyngeal suctioning every 4 hours, in additio
Participants in this group will receive scheduled oropharyngeal suctioning every 4 hours, in addition to routine oral care (twice-daily brushing of teeth, gums, and tongue). The oropharyngeal suctioning involves the mechanical removal of secretions from the oral cavity and pharynx using a sterile suction catheter to prevent bacterial buildup and aspiration into the lungs. This intervention is intended to reduce the risk of early-onset Ventilator-Associated Pneumonia (VAP) by continuously clearing harmful secretions from the airway.
干预措施: Scheduled Oropharyngeal Suctioning Every 4 Hours (Procedure)
结局指标
主要结局
incidence of early-onset Ventilator-Associated Pneumonia (VAP) in mechanically ventilated ICU patients.
时间窗: The primary outcome measure, incidence of early-onset VAP, will be assessed from Day 1 to Day 5 of mechanical ventilation in the ICU, specifically during the period of scheduled oropharyngeal suctioning intervention.
VAP will be diagnosed using the Modified Clinical Pulmonary Infection Score (MCPIS), which evaluates clinical indicators such as body temperature, pulmonary secretions, white blood cell count, the PaO2/FiO2 ratio, and chest radiography findings. A score of ≥6 on the MCPIS indicates the presence of VAP. This primary outcome will help determine whether the intervention (scheduled oropharyngeal suctioning every 4 hours) significantly reduces the incidence of VAP compared to standard oral care practices in ICU patients.
次要结局
未报告次要终点
研究者
Hafiz Abdul Wajid
Principal Investigator
University of Health Sciences Lahore