Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope - a Prospective, Multicenter Trial, Assessing the Feasibility of the VISUAL Method (Video Surfactant Administration Laryngoscopy)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Primary outcome measures
研究概览
简要总结
Surfactant administration via thin catheter using a specially adapted video laryngoscope - a prospective, multicenter trial, assessing the feasibility of the VISUAL method (Video Surfactant Administration Laryngoscopy).
The study will search for the number of attempts until surfactant is administrated, assessment of the infants' stability during the procedure, duration of the entire procedure, form laryngoscope insertion to surfactant administration.
详细描述
In this study the investigators intend to assess the feasibility of surfactant administration via a thin catheter using a specially adapted video laryngoscope, with a groove designed to allow insertion of an endovascular catheter without the use of other instruments in the oral cavity (forceps ect.).
The laryngoscope is manufactured by Peak Medic Ltd, Natania, Israel.
Primary Endpoints
-
- Number of attempts until surfactant is administrated
-
- Assessment of the infants' stability during the procedure - saturation, bradycardia, tachycardia.
-
- Duration of the entire procedure, form laryngoscope insertion to surfactants administration.
-
Secondary Endpoints
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature infants with gestational age 30-36 weeks.
- •Diagnosis of respiratory distress syndrome
- •Spontaneously breathing with non-invasive positive pressure ventilation.
- •Maximal age 3 days.
排除标准
- •Apgar score at 5 min < 5
- •Need for chest compressions or medication upon delivery.
- •Evident major congenital malformation, metabolic or genetic disorders.
- •Clinical evidence of sepsis.
结局指标
主要结局
Primary outcome measures
时间窗: 1 year
Success for surfactant administration - yes / no
次要结局
- Secondary outcome measures 1(1 year)
- Secondary outcome measures 2(1 year)
- Secondary outcome measures 4(1 year)
- Secondary outcome measures 6(1 year)
- Secondary outcome measures 5(1 year)
- Secondary outcome measures 3(1 year)
研究者
Dany Waisman
Director of the Newborn Unit Department of Neonatology
Carmel Medical Center