A Single Centre, Open-label, Feasibility Randomised Controlled Trial to Evaluate Gastric Microaspiration in Critically Ill Patients Intubated Using the Venner PneuX System Compared to Standard of Care Using Pepsin Biomarker (VAP-X)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To assess if a recruitment rate of 50 patient annually is achievable and identify any barriers to recruitment
研究概览
简要总结
This is a single centre, open-label, feasibility randomised controlled trial. The study aims to assess the feasibility of conducting an RCT to compare the PneuX ETT with standard care in hospitalised patients requiring mechanical ventilation. The patient population for this study are those who are experiencing critical illness requiring intubation and ventilatory support. Patients will be randomised in equal proportions into one of 2 arms: to be intubated using a Venner PneuX Endotracheal Tube (ETT) or using the standard tube. For this feasibility study, a total of 50 patients will be randomised into two groups (25 in each). All patients will be recruited at a single site (University Hospital of Wales, part of Cardiff & Vale UHB). The study will investigate several feasibility measures including recruitment, delivery of the intervention (including device-related adverse events), acceptability and adherence to the intervention and sampling, use of Peptest to measure microaspiration events, rate of pepsin positive samples, rate of tracheobronchial colonisation, volume of sub-glottic aspirate, rate of VAP, length of ICU and hospital stay, demonstrate the validity of study documentation and provide preliminary data for 50 patients. The data will inform the pilot and main phase of the study.
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
- Single (Participant)
盲法说明
Due to the nature of the interventional device it is not possible to blind the care providers or outcome assessors to the intervention group. The trial participants will be unconscious/sedated for the duration of the period that the PneuX device or standard ETT is in place and therefore will be unaware of their allocation. Samples sent to the laboratory for analysis will be anonymised using individual deidentified numbers for each participant.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old (no upper age)
- •Patient required endotracheal intubation
- •Expect to remain intubated for 24 hours post randomisation
排除标准
- •The person intubating the patient assesses that the patient has already aspirated.
- •GCS 7 or less on presentation to hospital
- •Patient is pregnant
- •Patient has tracheostomy
- •Patient has gastrectomy
- •Patients who have been intubated prior to arrival at hospital
- •Patients who are already endotracheally intubated and require a tube change.
研究组 & 干预措施
PneuX endotracheal tube
Patients will be intubated using the PneuX endotracheal tube system
干预措施: PneuX Endotracheal Tube (Device)
Standard care
Patients will be intubated using standard endotracheal tube (Taperguard, Covidien).
干预措施: Standard care (Taperguard, Covidien) (Device)
结局指标
主要结局
To assess if a recruitment rate of 50 patient annually is achievable and identify any barriers to recruitment
时间窗: Through study completion, an average of 1 year
The recruitment rate will be assessed using the "screening and recruitment log" which will record the number of patients recruited each month and reasons for non-recruitment will be described
次要结局
- Number of participants with a failed pepsin test(Duration of study treatment (typically 4-7 days))
- Proportion of patients who require antibiotics(28 days)
- Rate of Ventilator Associated Pneumonia (VAP)(28 days)
- Number of participants with a positive pepsin tracheal aspirate sample using Peptest(Duration of study treatment (typically 4-7 days))
- Time spent on the ventilator(Duration of study treatment (typically 4-7 days))
- Number of days spent in ICU and hospital(28 days)
- Rate of in-hospital mortality(28 days)
- To assess the feasibility of delivering the study intervention(Duration of study treatment (typically 4-7 days))
- Volume of sub-glottic aspirates(Duration of study treatment (typically 4-7 days))
- Rate of tracheobronchial colonization(Duration of study treatment (typically 4-7 days))
- Rate of compliance with measuring and documenting cuff pressure(Duration of study treatment (typically 4-7 days))