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Completed

NCT Number: NCT01924559

Comparison of Airway Intubation Devices When Using a Biohazard Suit

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.

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Key information

Age range

18 year–126 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard clothing

Other

Biohazard gear

Other

direct laryngoscopy

Device

Other names: (the classic standard of care)

Glidescope

Device

Supraglottic Airway

Device

Other names: Supraglottic Airway Laryngopharyngeal Tube

Primary outcomes

  1. Time to Successful Intubation

    Time frame: approximately one minute

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

Sponsors and collaborators

Lead sponsor

Lehigh Valley Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 16, 2013
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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