Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope - the VISUAL Method (VISUAL)
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)
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.
研究概览
详细说明
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.
4. Secondary Endpoints
- - Need of invasive mechanical ventilation in the next 24 hours.
- - Complications reports
- - Subjective procedure scale of assessment
- - Unexpected pitfalls reports
- - Safety assessment of the procedure
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Haifa、以色列
- Department of Neonatology, Carmel Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- - 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.
Exclusion Criteria:
- - 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：treatment feasibility
feasibility, safety and effectiveness assessment
|
thin catheter insertion between vocal cords under direct specially adapted videolaryngoscopy
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Primary outcome measures
大体时间：1 year
|
Success for surfactant administration - yes / no
|
1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Secondary outcome measures 1
大体时间：1 year
|
Assessment of the infants' SPO2 %
|
1 year
|
|
Secondary outcome measures 2
大体时间：1 year
|
Heart rate during the procedure
|
1 year
|
|
Secondary outcome measures 3
大体时间：1 year
|
Respiratory rate (breaths per minute)
|
1 year
|
|
Secondary outcome measures 4
大体时间：1 year
|
number of attempts for vocal cords visualization (number)
|
1 year
|
|
Secondary outcome measures 5
大体时间：1 year
|
Duration of the procedure (seconds)
|
1 year
|
|
Secondary outcome measures 6
大体时间：1 year
|
Need for mechanical ventilaton witin 24 hours following procedure (yes-no)
|
1 year
|
合作者和调查者
调查人员
- 首席研究员：Dan I Waisman, MD、Department of Neonatology, Carmel Medical Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.