Time of Device Positioning of LISA Rigid Catheter vs LISA Soft Catheter in a Very Preterm Manikin: A Crossover Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Total time of device (catheter) positioning
研究概览
简要总结
Less invasive surfactant administration (LISA) can be provided using rigid or soft catheters, but possible differences in terms of easiness of use and success of the procedure are unknown. A difficult procedure may have some drawbacks such as the prolonged duration of the laryngoscopy needed to insert the device, which is likely to aggravate the invasiveness of the procedure and result in stressful consequences such as bradycardia, hypoxia, and hemodynamic changes.
Objectives: i) time of device positioning, ii) success of the procedure of positioning the device, iii) participant's satisfaction.
详细描述
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA with a rigid catheter vs. LISA with a soft catheter in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the total time of device positioning. The secondary outcomes will be the success of the first attempt, the number of attempts to achieve the correct positioning of the device in the trachea, the achievement of the correct depth of the catheter in the trachea, and the participant's opinion on using the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Statistician will be blinded of the treatment group
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Level III NICU consultants and residents will be eligible to participate in the study
排除标准
- •There are no exclusion criteria for this study
结局指标
主要结局
Total time of device (catheter) positioning
时间窗: 5 minutes
The time of device positioning defined as the time elapsed from the positioning of the laryngoscope in the manikin mouth to the connection of the syringe for surfactant administration to the catheter
次要结局
- Achievement of the correct depth of the catheter in the trachea(5 minutes)
- Participant's opinion regarding the procedure(5 minutes)
- Success of device positioning at the first attempt(1 minute)
研究者
Daniele Trevisanuto
Associate Professor
University Hospital Padova