Preliminary study to assess the performance of a device designed to perform automatic suctioning of oropharyngeal and subglottic secretions and perform automated oral lavage in orotracheally intubated ICU patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The performance will be measured by the following endpoints:
研究概览
简要总结
Oral hygiene management, through suctioning secretions and anti-microbial mouth lavage, is a key procedure for intubated and ventilated patients- as it has been shown to be very effective in reducing the incidence of pneumonia (VAP) in such long-term intubated patients.
Currently, this procedure is performed manually by the ICU nurse, with highly variable effectiveness. This is because factors such as user training, workload, hand hygiene practices, among others can vary widely across institutions. Consequently, poor oral hygiene management is considered a key reason for the high rates of VAP seen in India.
VAPCare is a system that can provide a consistent and effective secretion removal and oral hygiene management to ventilated ICU patients. This study is needed to evaluate the safety and efficacy of this system in the real-world setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients requiring mechanical ventilation for 48 hrs or more
- •Patients must be between
- •75 years of age (Male or Female).
- •Patient must have been intubated with Portex (Smiths Medical) a CASS ET Tube.
- •A physician is able to place the suction lumen appropriately and fix it in position
- •Patient or a legal representative of the patient must be able to give written consent for the study.
排除标准
- •Patient intubated for more than 12 hours
- •Patient admitted for cardiac surgery/post cardiac surgery
- •Patient admitted with tracheostomy
- •Patient with bleeding disorders
- •Patient on oral anticoagulants
- •Patient with head, neck or facial injury
- •Patient is pregnant
- •Patient has pre-existing pneumonia at time of admission 10.
结局指标
主要结局
The performance will be measured by the following endpoints:
时间窗: 1. After 6 months | 2. After 1 year
1. Volume of secretions collected
时间窗: 1. After 6 months | 2. After 1 year
2. Visual confirmation of lavage and suction cycles
时间窗: 1. After 6 months | 2. After 1 year
3. Visual confirmation of secretion clearance
时间窗: 1. After 6 months | 2. After 1 year
The primary objective of the study is to demonstrate the performance of the device (VAPCare)
时间窗: 1. After 6 months | 2. After 1 year
次要结局
- To demonstrate the safety of the device (VAPCare).(After 6 Months of the study initiation.)
- To record the final patient outcomes.(Dual: After 1 year of the study.)