Clinical Trials Directory

Trials / Completed

CompletedNCT01924559

Comparison of Airway Intubation Devices When Using a Biohazard Suit

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
37 (actual)
Sponsor
Lehigh Valley Hospital · Academic / Other
Sex
All
Age
18 Years – 126 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
OTHERstandard clothing
OTHERBiohazard gear
DEVICEDirect Laryngoscopy
DEVICEGlidescope
DEVICESupraglottic Airway

Timeline

Start date
2013-08-01
Primary completion
2013-09-01
Completion
2013-09-01
First posted
2013-08-16
Last updated
2017-05-09
Results posted
2016-03-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01924559. Inclusion in this directory is not an endorsement.