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| Name | Class |
|---|---|
| University of Texas Southwestern Medical Center | OTHER |
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The overall purpose of this study is to assess the functionality & impact of the use of the newly designed GlideScope Spectrum pediatric video laryngoscope and stylet for the orotracheal intubation of neonates and pediatric patients, utilizing manikin models.
The overall purpose of this study is to assess the functionality & impact of the use of the newly designed GlideScope Spectrum pediatric video laryngoscope blades and stylet for the orotracheal intubation of neonates and pediatric patients, utilizing manikin models. The hypothesis is that the Spectrum laryngoscope blades and stylet can improve the time and/or success of orotracheal intubation in a manikin.
Secondary aims of this study include assessing the impact of Spectrum pediatric video laryngoscope blades under simulated normal and difficult airway conditions on glottic view grade, mouth space, ease of blade insertion, ease of tracheal tube insertion, mechanisms of tracheal tube insertion impediment, and perceived overall clinical & functional usefulness in airways with predictors of difficult intubation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants | Anesthesia and emergency medicine providers who perform pediatric orotracheal intubations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| orotracheal intubation | Device | orotracheal intubation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to intubate | Time to intubate on each of 3 attempts per blade, on each manikin type. | 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. |
| First pass success rate | First pass success rate on each of 3 attempts per blade, on each manikin type. First pass success (FPS) is defined as the ability to place a tracheal tube below a patient's vocal cords on the first attempt without removing the video laryngoscope from the patient's mouth. | 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. |
| Overall performance and clinical utility using a 5-point Likert Scale | Overall performance and clinical utility of single-use pediatric stylet; Using a 5-point LIKERT SCALE, participants will grade the following statements with regards to the use of the single-use pediatric stylet
| 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. |
| Measure | Description | Time Frame |
|---|---|---|
| Failed intubation attempt | The time taken for an intubation attempt that ultimately fails proper tube placement, or exceeds the allowed time for intubation under this protocol. Failed intubation attempt is defined as an attempt to intubate that does not result in tube placement, that is longer than 120 seconds, or results in a wrong placement of endotracheal tube (For example: Esophageal intubation, etc.). |
| Measure | Description | Time Frame |
|---|---|---|
| Glottic view grade | Glottic view grade on each of 3 attempts per blade, on each manikin type using the Cormack & Lehane grading scale:
| 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. |
Inclusion Criteria:
Exclusion Criteria:
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Clinicians, anesthesia, and emergency medicine providers who perform pediatric intubations. Participants will be recruited from Children's Medical Center, Dallas.
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Olomu, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75235 | United States |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. |
| Intubation success on first attempt | Cumulative measure of intubation success on first attempt over 3 successive uses of the pediatric video laryngoscope, per blade, on each manikin type. | 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. |
| Time to visualize glottis | Time to visualize the glottis on each of 3 attempts per blade, on each manikin type. | 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. |
| Assessment of clinical utility and performance using a Lickert scale | Assessment of the clinical utility and performance of the pediatric blades using a 5-point Lickert scale, where 1 = strongly disagree, 2 = disagree, 3= neutral, 4 = agree, 5 = strongly agree.
| 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. |
| Observational description of features causing impediments | Participant self-reported observational description of potential features causing intubation impediments to tracheal tube insertion (e.g., tube hitting the epiglottis or tube hitting the arytenoid). Recorded by the study subject at the time of attempt at placing a tracheal tube below a patient's vocal cords using each of the pediatric video laryngoscope blades. | 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. |
| Overall clinical usefulness | Recorded as excellent, good, fair, or inadequate by the study subject when using the pediatric video laryngoscope and stylet to place a tracheal tube below a patient's vocal cords. | 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. |
| Overall satisfaction of operator | Recorded as excellent, good, fair, or inadequate by the study subject when using each of the pediatric video laryngoscope blades and stylet to place a tracheal tube below manikin's vocal cords. | 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |