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The investigators plan to conduct a randomized trial comparing the efficacy of intubating the tracheal using an Aintree intubation catheter through either the LMA-S or I-gel supraglottic devices
With the proposal, the investigators are comparing two different types of supraglottic devices. One is the LMA Supreme (laryngeal mask airway) and the other is the I-gel. The study is designed to use the supraglottic airway device as an adjunct to tracheal intubation, not as the definitive airway. The investigators will be utilizing the Aintree intubation catheter over the fiberoptic bronchoscope in an effort to secure the airway. This technique has been well described in the literature and has been proven effective and safe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LMA-Supreme supraglottic device | Experimental | The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff |
|
| I-gel supraglottic device | Active Comparator | The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LMA-Supreme supraglottic device | Device | The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Successful Tracheal Intubation | This measure of time begins with the handling of the supraglottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide. | Up to 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Placement of the Supra Glottic Device | This measure of time begins with the handling of the supra glottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide | Up to 10 minutes |
| Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device |
| Measure | Description | Time Frame |
|---|---|---|
| Visualization Score | The visualization of each of the following structures provides one point, for a maximum score of 7.
| Up to 10 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Hernandez, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States | ||
| South Texas Veterans HealthCare System |
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| ID | Title | Description |
|---|---|---|
| FG000 | I-gel Supraglottic Device | The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff. I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway. |
| FG001 | LMA-Supreme Supraglottic Device | The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LMA-Supreme Supraglottic Device | The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data not available for 10 subjects |
| 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 Successful Tracheal Intubation | This measure of time begins with the handling of the supraglottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide. | unable to confirm accuracy of data in 1 participant in the I-gel group, that participant's data was not included in the analysis | Posted | Mean | Standard Deviation | seconds | Up to 10 minutes |
|
from start of anesthesia to successful intubation, up to 10 minutes
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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 | I-gel Supraglottic Device | The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff. I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coughing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antonio Hernandez, MD | Vanderbilt University Medical Center | 615 322-4650 | antonio.hernandez@vanderbilt.edu |
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| I-gel supraglottic device | Device | The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway. |
|
Percent of subjects who required 0, 1, 2, and 3 airway manipulations for the placement of the supraglottic device |
| Up to 10 minutes |
| Time to Placement of the Aintree Airway Intubation Catheter | This measure of time begins with the handling of the fiberscope to withdrawal of the fiberscope from the Aintree and setting the fiberscope down | Up to 10 minutes |
| Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree. | Percent of subjects who required 0, 1, 2, 3 and 6 airway manipulations for the placement of the Aintree. | Up to 10 minutes |
| Time to Placement of the Endotrotracheal Tube | Time to the appropriate placement of the endotracheal tube. | Up to 10 minutes |
| Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube | Percent of subjects with 0, 1, 2 and 3 airway manipulations required for placement of endotrachial tube | Up to 10 minutes |
| San Antonio |
| Texas |
| 78229 |
| United States |
| BG001 | I-gel Supraglottic Device | The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff. I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Data not available for 10 subjects | 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 | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| OG001 | LMA-Supreme Supraglottic Device | The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway. |
|
|
| Secondary | Time to Placement of the Supra Glottic Device | This measure of time begins with the handling of the supra glottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide | unable to confirm accuracy of data in 1 participant in the I-gel group, that participant's data was not included in the analysis | Posted | Mean | Standard Deviation | seconds | Up to 10 minutes |
|
|
|
| Secondary | Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device | Percent of subjects who required 0, 1, 2, and 3 airway manipulations for the placement of the supraglottic device | 4 participants in the LMA-Supreme arm were not included in analysis because the study was aborted at the request of the attending or the times to established safety cutoff for airway establishment (10 minutes) was exceeded. | Posted | Number | percent of participants | Up to 10 minutes |
|
|
|
| Secondary | Time to Placement of the Aintree Airway Intubation Catheter | This measure of time begins with the handling of the fiberscope to withdrawal of the fiberscope from the Aintree and setting the fiberscope down | unable to confirm accuracy of data in 1 participant in the I-gel group, that participant's data was not included in the analysis | Posted | Mean | Standard Deviation | seconds | Up to 10 minutes |
|
|
|
| Secondary | Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree. | Percent of subjects who required 0, 1, 2, 3 and 6 airway manipulations for the placement of the Aintree. | 2 participants in I-gel arm were excluded from analysis because times to established safety cutoff for airway establishment(10 minutes) was exceeded. 3 participants in LMA-Supreme arm were excluded in analysis because study was aborted at request of attending or times to established safety cutoff for airway establishment (10 minutes) was exceeded. | Posted | Number | percent of participants | Up to 10 minutes |
|
|
|
| Secondary | Time to Placement of the Endotrotracheal Tube | Time to the appropriate placement of the endotracheal tube. | unable to confirm accuracy of data in 1 participant in the I-gel group, that participant's data was not included in the analysis | Posted | Mean | Standard Deviation | second | Up to 10 minutes |
|
|
|
| Secondary | Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube | Percent of subjects with 0, 1, 2 and 3 airway manipulations required for placement of endotrachial tube | 2 participants in I-gel arm were excluded from analysis because times to established safety cutoff for airway establishment(10 minutes) was exceeded. 5 participants in LMA-Supreme arm were excluded in analysis because study was aborted at request of attending or times to established safety cutoff for airway establishment (10 minutes) was exceeded. | Posted | Number | percent of participants | Up to 10 minutes |
|
|
|
| Other Pre-specified | Visualization Score | The visualization of each of the following structures provides one point, for a maximum score of 7.
| Posted | Mean | Standard Deviation | units on a scale | Up to 10 minutes |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 1 |
| 20 |
| EG001 | LMA-Supreme Supraglottic Device | The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway. | 0 | 19 | 0 | 19 | 0 | 19 |
| Post Extubation Stridor | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| 2 manipulations |
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| 3 manipulations |
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| 2 manipulations |
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| 3 manipulations |
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| 6 manipulations |
|
| 2 manipulations |
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| 3 manipulations |
|