Comparison of Airway Intubation Devices When Using a Biohazard Suit

NCT ID: NCT01924559

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2013-09-30

Brief 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

Intubation; Difficult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Direct Laryngoscopy & standard clothing

Residents will intubate manikin using DL while wearing standard clothing.

Group Type: ACTIVE_COMPARATOR

standard clothing

Intervention Type: OTHER

Direct Laryngoscopy

Intervention Type: DEVICE

Direct Laryngoscopy & Biohazard Gear

Residents will intubate manikins using DL while in Biohazard gear.

Group Type: ACTIVE_COMPARATOR

Biohazard gear

Intervention Type: OTHER

Direct Laryngoscopy

Intervention Type: DEVICE

Glidescope & standard clothing

Residents will intubate manikins using Glidescope while wearing standard clothing.

Group Type: EXPERIMENTAL

standard clothing

Intervention Type: OTHER

Glidescope

Intervention Type: DEVICE

Glidescope & Biohazard Gear

Residents will intubate manikins using Glidescope while wearing Biohazard gear.

Group Type: ACTIVE_COMPARATOR

Biohazard gear

Intervention Type: OTHER

Glidescope

Intervention Type: DEVICE

Supraglottic Airway & standard clothing

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

Group Type: ACTIVE_COMPARATOR

standard clothing

Intervention Type: OTHER

Supraglottic Airway

Intervention Type: DEVICE

Supraglottic Airway and Biohazard gear

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

Group Type: ACTIVE_COMPARATOR

Biohazard gear

Intervention Type: OTHER

Supraglottic Airway

Intervention Type: DEVICE

Interventions

standard clothing

Intervention Type: OTHER

Biohazard gear

Intervention Type: OTHER

Direct Laryngoscopy

Intervention Type: DEVICE

Glidescope

Intervention Type: DEVICE

Supraglottic Airway

Intervention Type: DEVICE

Other Intervention Names

(the classic standard of care); Supraglottic Airway Laryngopharyngeal Tube

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 126 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lehigh Valley Hospital

OTHER

Sponsor Role: lead

Responsible Party

Marna Rayl Greenberg

Director of Emergency Medicine Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Scott Lipkin, DPM, CIP

Role: STUDY_DIRECTOR

Director, Research Participant Protection Office

Locations

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 25817200 (View on PubMed)

Other Identifiers

PRO00000982

Identifier Type: -

Identifier Source: org_study_id