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Endotracheal intubation is the gold standard for securing the airway. However, while managing patients with difficult airways, various supraglottic devices have been used as rescue airway devices. The aim of this study is to compare the fiberoptic view through the internal aspect of the i-gel versus the Air-Q LMA in pediatric patients. By examining the fiberoptic view through these two devices, the investigators will determine which device provides a clearer passage to the glottic opening and is therefore the preferred conduit to aid endotracheal intubation in difficult airways.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Air-Q | Active Comparator | The Air-Q is composed of an airway tube that connects to an elliptical mask with a cuff which is inserted through the patient's mouth, down the windpipe, and once deployed forms an airtight seal on top the glottis (unlike tracheal tubes which pass through the glottis) allowing a secure airway to be managed by a health care provider. |
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| i-gel | Experimental | The i-gel is designed to create a non-inflatable anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding the compression trauma that can occur with inflatable supraglottic airway devices. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Air-Q | Device |
| ||
| i-gel |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptable View of the Glottic Aperature (Grade I-II) | Grade I view - Glottic aperture seen completely without any obstruction, Grade II view - Glottic aperture seen only partially but visual obstruction is less than 50%. | 15 seconds after insertion of Air-Q or i-gel |
| Measure | Description | Time Frame |
|---|---|---|
| Airway Insertion Time | Amount of time it takes to insert airway. | Immediately after anesthesia induction |
| Time to Achieve Best Fiberoptic View | After confirmation of adequate placement and ventilation, a flexible fiberoptic bronchoscope was inserted through the stem of the supraglottic device to visualize the glottic aperture. The time taken for bronchoscopy, defined as time from disconnection of the anesthetic circuit from the SGA to first visualization of the glottic aperture, was recorded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Air-Q | The Air-Q is composed of an airway tube that connects to an elliptical mask with a cuff which is inserted through the patient's mouth, down the windpipe, and once deployed forms an airtight seal on top the glottis (unlike tracheal tubes which pass through the glottis) allowing a secure airway to be managed by a health care provider. Air-Q |
| FG001 | I-gel | The i-gel is designed to create a non-inflatable anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding the compression trauma that can occur with inflatable supraglottic airway devices. i-gel |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Air-Q | The Air-Q is composed of an airway tube that connects to an elliptical mask with a cuff which is inserted through the patient's mouth, down the windpipe, and once deployed forms an airtight seal on top the glottis (unlike tracheal tubes which pass through the glottis) allowing a secure airway to be managed by a health care provider. Air-Q |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Acceptable View of the Glottic Aperature (Grade I-II) | Grade I view - Glottic aperture seen completely without any obstruction, Grade II view - Glottic aperture seen only partially but visual obstruction is less than 50%. | Posted | Number | participants | 15 seconds after insertion of Air-Q or i-gel |
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Day of surgery
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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 | Air-Q | The Air-Q is composed of an airway tube that connects to an elliptical mask with a cuff which is inserted through the patient's mouth, down the windpipe, and once deployed forms an airtight seal on top the glottis (unlike tracheal tubes which pass through the glottis) allowing a secure airway to be managed by a health care provider. Air-Q |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senthil Krishna, MD | Nationwide Children's Hospital | 614-722-4200 | Senthil.Krishna@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 | Aug 7, 2015 | Jul 29, 2019 | Prot_SAP_000.pdf |
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|
| 15 seconds after insertion of Air-Q or i-gel |
| BG001 |
| I-gel |
The i-gel is designed to create a non-inflatable anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding the compression trauma that can occur with inflatable supraglottic airway devices. i-gel |
| BG002 | Total | Total of all reporting groups |
| years |
|
| 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 |
|
| Weight | Median | Inter-Quartile Range | kilograms |
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| Secondary | Airway Insertion Time | Amount of time it takes to insert airway. | Posted | Median | Inter-Quartile Range | seconds | Immediately after anesthesia induction |
|
|
|
| Secondary | Time to Achieve Best Fiberoptic View | After confirmation of adequate placement and ventilation, a flexible fiberoptic bronchoscope was inserted through the stem of the supraglottic device to visualize the glottic aperture. The time taken for bronchoscopy, defined as time from disconnection of the anesthetic circuit from the SGA to first visualization of the glottic aperture, was recorded. | Posted | Median | Inter-Quartile Range | seconds | 15 seconds after insertion of Air-Q or i-gel |
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|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | I-gel | The i-gel is designed to create a non-inflatable anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding the compression trauma that can occur with inflatable supraglottic airway devices. i-gel | 0 | 25 | 0 | 25 | 0 | 25 |
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