Comparison of Airway Intubation Devices When Using a Biohazard Suit

Lehigh Valley Hospital

Status: Completed

Conditions: Intubation; Difficult

Treatments: Device: Supraglottic Airway; Other: standard clothing; Device: Direct Laryngoscopy; Other: Biohazard gear; Device: Glidescope

Study type: Interventional

Funder types: Other

Identifiers

NCT01924559

PRO00000982

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 126 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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37 participants in 6 patient groups

Direct Laryngoscopy & standard clothing

Active Comparator group

Description:

Residents will intubate manikin using DL while wearing standard clothing.

Treatment:

Other: standard clothing

Device: Direct Laryngoscopy

Direct Laryngoscopy & Biohazard Gear

Active Comparator group

Description:

Residents will intubate manikins using DL while in Biohazard gear.

Treatment:

Device: Direct Laryngoscopy

Other: Biohazard gear

Glidescope & standard clothing

Experimental group

Description:

Residents will intubate manikins using Glidescope while wearing standard clothing.

Treatment:

Device: Glidescope

Other: standard clothing

Glidescope & Biohazard Gear

Active Comparator group

Description:

Residents will intubate manikins using Glidescope while wearing Biohazard gear.

Treatment:

Device: Glidescope

Other: Biohazard gear

Supraglottic Airway & standard clothing

Active Comparator group

Description:

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

Treatment:

Other: standard clothing

Device: Supraglottic Airway

Supraglottic Airway and Biohazard gear

Active Comparator group

Description:

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

Treatment:

Other: Biohazard gear

Device: Supraglottic Airway