Nasopharyngeal Airway Guide Nasogastric Tube Placement

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追踪信息

首次提交日期 ^ICMJE

October 4, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

October 2018

预计主要完成日期

October 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

First attempt successful rate[ Time Frame: can be know after NG tube placement immediately ]

with or without Nasopharyngeal airway assistance

Second attempt successful rate[ Time Frame: can be know after NG tube placement immediately ]

with or without Nasopharyngeal airway assistance

Overall successful rate insertion[ Time Frame: can be know after NG tube placement immediately ]

with or without Nasopharyngeal airway assistance

Time cost during NG tube placement[ Time Frame: can be know after NG tube placement immediately ]

with or without Nasopharyngeal airway assistance

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Incidence of NG tube coiling[ Time Frame: can be know after NG tube placement immediately ]
with or without Nasopharyngeal airway assistance during NG tube insertion
Incidence of NG tube kinking[ Time Frame: can be know after NG tube placement immediately ]
with or without Nasopharyngeal airway assistance during NG tube insertion
Incidence of NG tube knotting[ Time Frame: can be know after NG tube placement immediately ]
with or without Nasopharyngeal airway assistance during NG tube insertion
Incidence of epistaxis after NG tube placement[ Time Frame: can be know after NG tube placement immediately ]
with or without Nasopharyngeal airway assistance during NG tube insertion
Mean blood pressure change after NG tube placement[ Time Frame: can be know after NG tube placement immediately ]
with or without Nasopharyngeal airway assistance
Heart rate change after NG tube placement[ Time Frame: can be know after NG tube placement immediately ]
with or without Nasopharyngeal airway assistance

描述性信息

简略标题 ^ICMJE

Nasopharyngeal Airway Guide Nasogastric Tube Placement

正式标题 ^ICMJE

Nasopharyngeal Airway Guide Nasogastric Tube Placement in Anesthetized and Intubated Patient: A Prospective Randomized Control Study

简要概况

Nasogastric tube placement is essential for various surgery and critically ill patients. However, NG tube insertion in anesthetized, paralyzed, and intubated or unconscious patients may be difficult, with reported success rate less 50% on the first attempt without any auxiliary devices. Endotracheal tube intubation narrow the space of oropharynx and hypopharynx. Loss ability to swallow and tongue drop also made the NG tube coil in the mouth easily. We assume nasopharyngeal airway can facilitate NG tube insertion by opening a channel from nostril to epiglottis and reduce complications by protecting nasal cavity while insertion.

详细说明

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Procedure: With nasopharyngeal airway
Nasopharyngeal airway is previously inserted into selected nostril. NG tube is properly lubricated and placed through Nasopharyngeal airway.
Procedure: Without nasopharyngeal airway
NG tube is properly lubricated and placed into selected nostril

研究工具

Experimental: NG tube placement with nasopharyngeal tube
Active Comparator: NG tube placement with without nasopharyngeal tube

招募信息

招募状态 ^ICMJE

Recruiting

预计入组 ^ICMJE

120

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

December 2019

预计主要完成日期

October 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Patient should be > 20 years old, ASA 1~3 under going schedule general anesthesia with endotracheal tube intubation - Patient who required NG tube placement for perioperative care Exclusion Criteria: - Coagulation abnormality (PLT≤100000, INR>1.2 & PT≥13) - Hemodynamic unstable (with inotropic agent use) - Arrythmia - Esophageal varices or stricture, Esophageal cancer, trauma or previous esophageal surgery - Gastric cancer involve cardiac orifice - Corrosive chemical (strong acid or alkali) ingestion - Skull base fracture - Recent nasal surgery, nasal fracture or severe nasal obstruction - Loose teeth that make endotracheal tube can not fix right side

性别

参与研究的性别:

All

年龄

最小年龄：20 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

Taiwan

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

Chang Gung Memorial Hospital

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

验证日期

April 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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