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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inexperienced users | Experimental | Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH. |
|
| Experienced users | Experimental | Experienced users will include faculty pediatric anesthesiologists CRNAs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miller | Device | Direct laryngoscopy and endotracheal intubation attempted by each provider using direct laryngoscopy (DL) with a Miller laryngoscope |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Endotracheal Intubation | The amount of time it took to successfully intubate the manikin using each device. | the same day (within seconds to minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Successful Intubation Within 120 Seconds | The number of participants who were able to successfully intubate the manikin using each device within 120 seconds. | 2 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Tobias, MD | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 |
| 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 Endotracheal Intubation | The amount of time it took to successfully intubate the manikin using each device. | Posted | Mean | Standard Deviation | seconds | the same day (within seconds to minutes) |
|
through study completion, an average of 1 year
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
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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 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph D. Tobias, MD | Nationwide Children's Hospital | 6147224200 | Joseph.Tobias@nationwidechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 24, 2016 | Mar 9, 2018 | Prot_SAP_000.pdf |
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| Macintosh | Device | Direct laryngoscopy and endotracheal intubation attempted by each provider using DL with a Macintosh laryngoscope |
|
| C-MAC | Device | Indirect laryngoscopy and endotracheal intubation attempted by each provider using the C-MAC video laryngoscope |
|
| GlideScope | Device | Indirect laryngoscopy and endotracheal intubation attempted by each provider using the GlideScope video laryngoscope |
|
| 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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Successful Intubation Within 120 Seconds | The number of participants who were able to successfully intubate the manikin using each device within 120 seconds. | Posted | Count of Participants | Participants | 2 minutes |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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). | 0 | 0 | 0 | 0 | 0 | 0 |
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| C-Mac |
|
| GlideScope |
|