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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct Laryngoscopy & standard clothing | Active Comparator | Residents will intubate manikin using DL while wearing standard clothing. |
|
| Direct Laryngoscopy & Biohazard Gear | Active Comparator | Residents will intubate manikins using DL while in Biohazard gear. |
|
| Glidescope & standard clothing | Experimental | Residents will intubate manikins using Glidescope while wearing standard clothing. |
|
| Glidescope & Biohazard Gear | Active Comparator | Residents will intubate manikins using Glidescope while wearing Biohazard gear. |
|
| Supraglottic Airway & standard clothing | Active Comparator | Residents will intubate manikins using Supraglottic Airway while wearing standard clothing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard clothing | Other |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Lipkin, DPM, CIP | Director, Research Participant Protection Office | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25817200 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | All participants were randomized into groups testing three intubation devices while wearing standard clothing or biohazard gear.. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Prospectively enrolled EM residents, including PGY 1s through 4s; each resident was observed performing all six arms of the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | SALT and Biohazard Gear | All participants were tested on three intubation devices in either standard clothing or biohazard gear. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Successful Intubation | Time from initiation of intubation attempt to successful 2 breaths demonstrating lung expansion, estimated less than 1 minute | EM Residents who tested/participated in each of the six groups | Posted | Mean | Full Range | seconds | approximately one minute |
|
Minimal risk study, N/A.
Minimal risk study, N/A.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DL & Standard Clothing | Residents will intubate manikin using DL while wearing standard clothing. standard clothing DL |
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Limitations described in associated reference
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marna Rayl Greenberg, DO, MPH | Lehigh Valley Hospital | 484-884-7514 | Marna.Greenberg@lvh.com |
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| Supraglottic Airway and Biohazard gear | Active Comparator | Residents will intubate manikins using Supraglottic airway while wearing biohazard gear. |
|
| Biohazard gear | Other |
|
| Direct Laryngoscopy | Device |
|
|
| Glidescope | Device |
|
| Supraglottic Airway | Device |
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 |
| Glidescope & Standard Clothing |
Residents will intubate manikins using Glidescope while wearing standard clothing. standard clothing Glidescope |
| OG003 | Glidescope & Biohazard Gear | Residents will intubate manikins using Glidescope while wearing Biohazard gear. Biohazard gear Glidescope |
| OG004 | SALT & Standard Clothing | Residents will intubate manikins using SALT while wearing standard clothing. standard clothing SALT |
| OG005 | SALT and Biohazard Gear | Residents will intubate manikins using SALT while wearing biohazard gear. Biohazard gear SALT |
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | DL & Biohazard Gear | Residents will intubate manikins using DL while in Biohazard gear. Biohazard gear DL | 0 | 37 | 0 | 37 |
| EG002 | Glidescope & Standard Clothing | Residents will intubate manikins using Glidescope while wearing standard clothing. standard clothing GlideScope | 0 | 37 | 0 | 37 |
| EG003 | Glidescope & Biohazard Gear | Residents will intubate manikins using Glidescope while wearing Biohazard gear. Biohazard gear GlideScope | 0 | 37 | 0 | 37 |
| EG004 | SALT & Standard Clothing | Residents will intubate manikins using SALT while wearing standard clothing. standard clothing SALT | 0 | 37 | 0 | 37 |
| EG005 | SALT and Biohazard Gear | Residents will intubate manikins using SALT while wearing biohazard gear. Biohazard gear SALT No adverse events | 0 | 37 | 0 | 37 |
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