Comparison of Airway Intubation Devices When Using a Biohazard Suit

Intubation; Difficult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01924559
• Other study ID #: PRO00000982
• Status: Completed
• Phase: N/A
• First received: August 6, 2013
• Last updated: March 22, 2016
• Start date: August 2013
• Est. completion date: September 2013

Study information

• Verified date: March 2016
• Source: Lehigh Valley Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 126 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Intubation; Difficult

Intervention

Other:
• standard clothing

• Biohazard gear

Device:
• Direct Laryngoscopy

• Glidescope

• Supraglottic Airway

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital	Allentown	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Lehigh Valley Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Weaver KR, Barr GC Jr, Long KR, Diaz L Jr, Ratner AS, Reboul JP, Sturm DA, Greenberg MR, Dusza SW, Glenn-Porter B, Kane BG. Comparison of airway intubation devices when using a biohazard suit: a feasibility study. Am J Emerg Med. 2015 Jun;33(6):810-4. doi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

External Links

•   Full text article available at Elsevier/AJEM