Does Personal Protective Equipment for the Prevention of SARS-Cov-2 Infection Impact the Timing of Ventilation in Neonates Needing Resuscitation at Birth? A Crossover Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- Initiation of positive pressure ventilation
研究概览
简要总结
There has been an increasing number of SARS-CoV-2 infections in pregnant women and neonates. Interventions including open airway suctioning, positive pressure ventilation, non-invasive respiratory support, tracheal intubation, and endotracheal drug administration are aerosol-generating medical procedures and may create a risk to the unprotected healthcare providers. The impact of using personal protective equipment during neonatal resuscitation maneuvers is unknown.
The objective of this study will be to compare the beginning of PPV and the duration of intubation between performing resuscitation with PPE for the prevention of SARS-Cov-2 infection and resuscitation without PPE for the prevention of SARS-Cov-2 infection.
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
- None
盲法说明
The statistician performing data analysis will be masked to treatment allocation.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Level III neonatal intensive care unit consultants, pediatric residents, and nurses. Participants will be divided into teams including a consultant and a nurse or a resident and a nurse during the simulation.
排除标准
- •There are no exclusion criteria for this study.
结局指标
主要结局
Initiation of positive pressure ventilation
时间窗: 5 minutes
次要结局
- Participant's opinion on discomfort using personal protective equipment(20 minutes)
- Correct use of personal protective equipment(20 minutes)
- Duration of intubation procedure(5 minutes)
- Time of initiation of chest compressions(20 minutes)
研究者
Daniele Trevisanuto
Associate Professor
University Hospital Padova