Intubation; Difficult
Conditions
Keywords
Airway
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.
Interventions
OTHERstandard clothing
OTHERBiohazard gear
DEVICEDirect Laryngoscopy
DEVICEGlidescope
DEVICESupraglottic Airway
Sponsors
Lehigh Valley Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 126 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Successful Intubation | approximately one minute | Time from initiation of intubation attempt to successful 2 breaths demonstrating lung expansion, estimated less than 1 minute |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SALT and Biohazard Gear All participants were tested on three intubation devices in either standard clothing or biohazard gear. | 37 |
| Total | 37 |
Baseline characteristics
| Characteristic | SALT and Biohazard Gear |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 37 | 0 / 37 | 0 / 37 | 0 / 37 | 0 / 37 | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 | 0 / 37 | 0 / 37 | 0 / 37 | 0 / 37 | 0 / 37 |
Outcome results
Primary
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
Population: EM Residents who tested/participated in each of the six groups
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DL & Standard Clothing | Time to Successful Intubation | 54 seconds |
| DL & Biohazard Gear | Time to Successful Intubation | 106.5 seconds |
| Glidescope & Standard Clothing | Time to Successful Intubation | 66 seconds |
| Glidescope & Biohazard Gear | Time to Successful Intubation | 83.5 seconds |
| SALT & Standard Clothing | Time to Successful Intubation | 73.5 seconds |
| SALT and Biohazard Gear | Time to Successful Intubation | 58.5 seconds |