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临床试验/NCT01924559
NCT01924559已完成不适用

Comparison of Airway Intubation Devices When Using a Biohazard Suit: A Feasibility Study

Lehigh Valley Hospital1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2013年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
1
主要终点
Time to Successful Intubation

研究概览

简要总结

We will investigate the impact biohazard gear has on time to successful intubation and, in particular, determine how the Supraglottic Airway Laryngopharyngeal Tube (Ecolab, Columbus, Missouri) device compares to traditional direct laryngoscopy and fiber-optic (video) intubation techniques.

详细描述

This study will take place in an academic/training facility at Lehigh Valley Health Network simulating intubation during a bio-terrorism attack. As a part of their usual (standard of care) residency education, the study volunteers will be participating in a day-long airway training course in the Fall of 2013 where each of the tested devices will be introduced and the residents will be able to practice using them on a variety of training mannequins.

As part of this training, the enrolled study subjects will be timed using each of three intubation devices, both with and without wearing biohazard protective gear, for a total of six measurements per resident. Residents will have been assigned chronological numbers as they arrived and signed in for the course. These numbers will be also used for study identification numbers. Subjects will be randomized by odd or even identification numbers as to whether they will make their initial attempt in street clothing or the biohazard suit. This will help control for individual subject's skill learning. The subject will then intubate the same mannequins using each of the tested devices.

The order of devices used will be the same as in actual clinical practice: 1) Direct Laryngoscopy (the classic standard of care), 2) the GlideScope or C-MAC video laryngoscope (fiber-optic technology, which has become increasingly popular among emergency physicians), and 3) the Supraglottic Airway Laryngopharyngeal Tube airway device (an inexpensive, convenient supraglottic device that allows for a blind intubation technique through the device).

Data will be collected, per device, on the time taken and tubes used for each attempt. Demographic information will also be collected from participants such as gender, resident year, prior intubation experience, prior exposure to each of the tested devices, and experience wearing a biohazard suit. Study participants' satisfaction with each of the devices will also be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 126 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Emergency Medicine residents who volunteer to participate and allow their data to be used for research purposes

排除标准

  • •Not an Emergency resident who volunteers to participate and allow their data to be used for research purposes

研究组 & 干预措施

Glidescope & Biohazard Gear

Active Comparator

Residents will intubate manikins using Glidescope while wearing Biohazard gear.

干预措施: Biohazard gear (Other)

Glidescope & Biohazard Gear

Active Comparator

Residents will intubate manikins using Glidescope while wearing Biohazard gear.

干预措施: Glidescope (Device)

Direct Laryngoscopy & standard clothing

Active Comparator

Residents will intubate manikin using DL while wearing standard clothing.

干预措施: Direct Laryngoscopy (Device)

Direct Laryngoscopy & standard clothing

Active Comparator

Residents will intubate manikin using DL while wearing standard clothing.

干预措施: standard clothing (Other)

Direct Laryngoscopy & Biohazard Gear

Active Comparator

Residents will intubate manikins using DL while in Biohazard gear.

干预措施: Biohazard gear (Other)

Direct Laryngoscopy & Biohazard Gear

Active Comparator

Residents will intubate manikins using DL while in Biohazard gear.

干预措施: Direct Laryngoscopy (Device)

Glidescope & standard clothing

Experimental

Residents will intubate manikins using Glidescope while wearing standard clothing.

干预措施: standard clothing (Other)

Glidescope & standard clothing

Experimental

Residents will intubate manikins using Glidescope while wearing standard clothing.

干预措施: Glidescope (Device)

Supraglottic Airway & standard clothing

Active Comparator

Residents will intubate manikins using Supraglottic Airway while wearing standard clothing.

干预措施: standard clothing (Other)

Supraglottic Airway & standard clothing

Active Comparator

Residents will intubate manikins using Supraglottic Airway while wearing standard clothing.

干预措施: Supraglottic Airway (Device)

Supraglottic Airway and Biohazard gear

Active Comparator

Residents will intubate manikins using Supraglottic airway while wearing biohazard gear.

干预措施: Biohazard gear (Other)

Supraglottic Airway and Biohazard gear

Active Comparator

Residents will intubate manikins using Supraglottic airway while wearing biohazard gear.

干预措施: Supraglottic Airway (Device)

结局指标

主要结局

Time to Successful Intubation

时间窗: approximately one minute

Time from initiation of intubation attempt to successful 2 breaths demonstrating lung expansion, estimated less than 1 minute

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marna Rayl Greenberg

Director of Emergency Medicine Research

Lehigh Valley Hospital

研究点 (1)

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