Videolaryngoscopes (VL), Direct Laryngoscopy (DL), Inexperienced Users
Conditions
Brief summary
This study will compare the CMAC and Glidescope videolaryngoscopes (VL) to traditional direct laryngoscopy (DL) using either a Miller or Macintosh laryngoscope by studying the performance of users. This will involve the use of an intubating pediatric manikin to assess various aspects of endotracheal intubation by experienced and inexperienced users.
Detailed description
The commonly used method for endotracheal intubation in children is direct laryngoscopy using a Miller or Macintosh blade. Videolaryngoscopy is a widely accepted pediatric airway management. Videolaryngoscopes (VL) provide an indirect view of glottis without the need to align the oral, pharyngeal, and glottis structures. Some types of VLs provide also direct view of glottis with indirect view. Videolaryngoscopes can be used as a teaching tool for learners as they can visualize all the anatomical structures of larynx at the same time with the performer. VLs may facilitate the learning of endotracheal intubation in inexperienced users in the pediatric population. There are limited data on the use of videolaryngoscopes by anesthesia providers and medical personnel who are inexperienced in the use of videolaryngoscopes.
Interventions
DEVICEMiller
Direct laryngoscopy and endotracheal intubation attempted by each provider using direct laryngoscopy (DL) with a Miller laryngoscope
DEVICEMacintosh
Direct laryngoscopy and endotracheal intubation attempted by each provider using DL with a Macintosh laryngoscope
DEVICEC-MAC
Indirect laryngoscopy and endotracheal intubation attempted by each provider using the C-MAC video laryngoscope
DEVICEGlideScope
Indirect laryngoscopy and endotracheal intubation attempted by each provider using the GlideScope video laryngoscope
Sponsors
Joseph D. Tobias
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Faculty pediatric anesthesiologists * CRNAs * Trainees (SRNAs, residents, fellows, and medical students) * Nurses from NCH
Exclusion criteria
* If subjects are unwilling to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Endotracheal Intubation | the same day (within seconds to minutes) | The amount of time it took to successfully intubate the manikin using each device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful Intubation Within 120 Seconds | 2 minutes | The number of participants who were able to successfully intubate the manikin using each device within 120 seconds. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Inexperienced Users Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH.
Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL). | 12 |
| Experienced Users Experienced users will include faculty pediatric anesthesiologists CRNAs.
Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL). | 31 |
| Total | 43 |
Baseline characteristics
| Characteristic | Experienced Users | Total | Inexperienced Users |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 43 Participants | 12 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 31 participants | 43 participants | 12 participants |
| Sex: Female, Male Female | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Time to Endotracheal Intubation
The amount of time it took to successfully intubate the manikin using each device.
Time frame: the same day (within seconds to minutes)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inexperienced Users | Time to Endotracheal Intubation | Miller | 72 seconds | Standard Deviation 45 |
| Inexperienced Users | Time to Endotracheal Intubation | Macintosh | 72 seconds | Standard Deviation 45 |
| Inexperienced Users | Time to Endotracheal Intubation | C-Mac | 61 seconds | Standard Deviation 34 |
| Inexperienced Users | Time to Endotracheal Intubation | GlideScope | 118 seconds | Standard Deviation 6 |
| Experienced Users | Time to Endotracheal Intubation | GlideScope | 85 seconds | Standard Deviation 38 |
| Experienced Users | Time to Endotracheal Intubation | Miller | 30 seconds | Standard Deviation 28 |
| Experienced Users | Time to Endotracheal Intubation | C-Mac | 20 seconds | Standard Deviation 13 |
| Experienced Users | Time to Endotracheal Intubation | Macintosh | 27 seconds | Standard Deviation 23 |
Secondary
Successful Intubation Within 120 Seconds
The number of participants who were able to successfully intubate the manikin using each device within 120 seconds.
Time frame: 2 minutes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inexperienced Users | Successful Intubation Within 120 Seconds | Miller | 7 Participants |
| Inexperienced Users | Successful Intubation Within 120 Seconds | Macintosh | 7 Participants |
| Inexperienced Users | Successful Intubation Within 120 Seconds | C-Mac | 11 Participants |
| Inexperienced Users | Successful Intubation Within 120 Seconds | GlideScope | 2 Participants |
| Experienced Users | Successful Intubation Within 120 Seconds | GlideScope | 20 Participants |
| Experienced Users | Successful Intubation Within 120 Seconds | Miller | 30 Participants |
| Experienced Users | Successful Intubation Within 120 Seconds | C-Mac | 31 Participants |
| Experienced Users | Successful Intubation Within 120 Seconds | Macintosh | 31 Participants |