Comparison of Airway Intubation Devices When Using a Biohazard Suit

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

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.

Study Overview

• Status: Completed
• Conditions: Intubation; Difficult
• Intervention / Treatment: Other: standard clothing; Device: Direct Laryngoscopy; Other: Biohazard gear; Device: Glidescope; Device: Supraglottic Airway

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 126 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lehigh Valley Hospital
• Investigators: Study Director: Scott Lipkin, DPM, CIP, Director, Research Participant Protection Office

Publications and helpful links

General Publications

• 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: 10.1016/j.ajem.2015.02.051. Epub 2015 Mar 6.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: August 6, 2013
• First Submitted That Met QC Criteria: August 15, 2013
• First Posted (Estimate): August 16, 2013

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: March 31, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Airway
• Other Study ID Numbers: PRO00000982

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO