Comparison of Airway Intubation Devices When Using a Biohazard Suit

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Intubation; Difficult

Intervention / Treatment
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* Other: standard clothing
* Other: Biohazard gear
* Device: Direct Laryngoscopy
* Device: Glidescope
* Device: Supraglottic Airway


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Emergency Medicine residents who volunteer to participate and allow their data to be used for research purposes Exclusion Criteria: Not an Emergency resident who volunteers to participate and allow their data to be used for research purposes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 126 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Direct Laryngoscopy & standard clothing<br>Residents will intubate manikin using DL while wearing standard clothing. | Other: standard clothing<br> <br> Device: Direct Laryngoscopy<br> <br> * Other names: (the classic standard of care);|
| Active Comparator: Direct Laryngoscopy & Biohazard Gear<br>Residents will intubate manikins using DL while in Biohazard gear. | Other: Biohazard gear<br> <br> Device: Direct Laryngoscopy<br> <br> * Other names: (the classic standard of care);|
| Experimental: Glidescope & standard clothing<br>Residents will intubate manikins using Glidescope while wearing standard clothing. | Other: standard clothing<br> <br> Device: Glidescope<br> <br> |
| Active Comparator: Glidescope & Biohazard Gear<br>Residents will intubate manikins using Glidescope while wearing Biohazard gear. | Other: Biohazard gear<br> <br> Device: Glidescope<br> <br> |
| Active Comparator: Supraglottic Airway & standard clothing<br>Residents will intubate manikins using Supraglottic Airway while wearing standard clothing. | Other: standard clothing<br> <br> Device: Supraglottic Airway<br> <br> * Other names: Supraglottic Airway Laryngopharyngeal Tube;|
| Active Comparator: Supraglottic Airway and Biohazard gear<br>Residents will intubate manikins using Supraglottic airway while wearing biohazard gear. | Other: Biohazard gear<br> <br> Device: Supraglottic Airway<br> <br> * Other names: Supraglottic Airway Laryngopharyngeal Tube;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Successful Intubation | Time from initiation of intubation attempt to successful 2 breaths demonstrating lung expansion, estimated less than 1 minute | approximately one minute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airway