An interventional study of standard clothing and Biohazard gear in Intubation; Difficult, sponsored by Lehigh Valley Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 126 Years. Per ClinicalTrials.gov, last updated 2017-05-09.
Sponsored by Lehigh Valley Hospital · Not applicable, Interventional, and Supportive care
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.
Lehigh Valley Hospital is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Residents will intubate manikin using DL while wearing standard clothing.
Other: standard clothing · Device: Direct Laryngoscopy
Residents will intubate manikins using DL while in Biohazard gear.
Other: Biohazard gear · Device: Direct Laryngoscopy
Residents will intubate manikins using Glidescope while wearing standard clothing.
Other: standard clothing · Device: Glidescope
Residents will intubate manikins using Glidescope while wearing Biohazard gear.
Other: Biohazard gear · Device: Glidescope
Residents will intubate manikins using Supraglottic Airway while wearing standard clothing.
Other: standard clothing · Device: Supraglottic Airway
Residents will intubate manikins using Supraglottic airway while wearing biohazard gear.
Other: Biohazard gear · Device: Supraglottic Airway
Also known as: (the classic standard of care)
Also known as: Supraglottic Airway Laryngopharyngeal Tube
Time to Successful Intubation
Time from initiation of intubation attempt to successful 2 breaths demonstrating lung expansion, estimated less than 1 minute
Time frame: approximately one minute
| Milestone | All Study Participants |
|---|---|
| Started | 37 |
| Completed | 37 |
| Not completed | 0 |
Time from initiation of intubation attempt to successful 2 breaths demonstrating lung expansion, estimated less than 1 minute
| seconds | DL & Standard Clothing | DL & Biohazard Gear | Glidescope & Standard Clothing | Glidescope & Biohazard Gear | SALT & Standard Clothing | SALT and Biohazard Gear |
|---|---|---|---|---|---|---|
| Time to Successful Intubation | 54 (25 to 189) | 106.5 (29 to 534) | 66 (19 to 298) | 83.5 (25 to 375) | 73.5 (13 to 328) | 58.5 (20 to 168) |
Collected over Minimal risk study, N/A.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DL & Standard Clothing | — | 0/37 (0%) | 0/37 (0%) |
| DL & Biohazard Gear | — | 0/37 (0%) | 0/37 (0%) |
| Glidescope & Standard Clothing | — | 0/37 (0%) | 0/37 (0%) |
| Glidescope & Biohazard Gear | — | 0/37 (0%) | 0/37 (0%) |
| SALT & Standard Clothing | — | 0/37 (0%) | 0/37 (0%) |
| SALT and Biohazard Gear | — | 0/37 (0%) | 0/37 (0%) |
Prospectively enrolled EM residents, including PGY 1s through 4s; each resident was observed performing all six arms of the study.
| Age, Categorical(Participants) | SALT and Biohazard Gear |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 37 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | SALT and Biohazard Gear |
|---|---|
| Female | 10 |
| Male | 27 |
Plan to share: No
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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