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| Name | Class |
|---|---|
| King Systems Corporation | INDUSTRY |
This is a single center trial to evaluate the performance of the King Vision video laryngoscope in pediatric patients between the ages of one month and 10 years of age. If the performance is satisfactory, this device may become a standard laryngoscope for tracheal intubation in elective and emergent tracheal intubations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video laryngoscope intubation | Other | The King Vision Video Laryngoscope will be used for intubation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| King Vision video Laryngoscope | Device | The King Vision video laryngoscope (Ambu) will be used for tracheal intubation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Endotracheal Intubation | Ease of endotracheal intubation | During intubation |
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Inclusion Criteria:
Exclusion Criteria:
1. Patients that will be excluded are those with an airway examination or previous anesthesia history that suggests difficulty with mask ventilation.
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Horn, MD | Riley Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children at IU Health | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ease of Endotracheal Tube Passage | Intubations rated as "easy" and answers collected yes or no. s |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants | Participant details |
| 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 | Ease of Endotracheal Intubation | Ease of endotracheal intubation | Posted | Number | participants | During intubation |
|
|
1 year
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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 | Adverse Event Participants | Adverse event affecting participant details | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Horn MD | Indiana University | 317-944-9981 | nhorn@iupui.edu |
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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: Study Protocol | Mar 28, 2016 | Mar 14, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 18, 2016 | May 28, 2019 | ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Data collection Sheet | Sep 14, 2015 | Jul 10, 2019 | SAP_002.pdf |
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| 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 |
|
|
| 65 |
| 0 |
| 65 |
| 0 |
| 65 |
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