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The purpose of this study is to determine if an I-gel laryngeal mask airway (LMA) has a higher oropharyngeal leak pressure compared to an Ambu Auragain in adult patients in an ambulatory surgery center.
Patients who are scheduled for elective ambulatory surgery under general anesthesia will be randomized to one of two groups. Group 1 will receive an I-gel laryngeal mask airway (LMA) and group 2 will receive an Ambu Auragain LMA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Igel Larnygeal Mask Airway | Experimental | Group 1 will receive the I-Gel Laryngeal Mask Airway for airway maintenance during general anesthesia |
|
| Ambu Auragain Laryngeal mask airway | Active Comparator | Group 2 will receive the Ambu Auragain Laryngeal Mask Airway for airway maintenance during general anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I-Gel Laryngeal Mask Airway | Device | The I-Gel Laryngeal Mask Airway is a medical device that keeps a patient's airway open during anaesthesia or unconsciousness. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oropharyngeal Leak Pressure (OLP) | OLP will be measured immediately after insertion. This will be accomplished by closing the expiratory valve while keeping fresh gas flow at 3 liters/minute until equilibrium is reached. Pressure will be reported in cmH2O. | immediately after placement |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Placement | Time required to place laryngeal mask airway will be measured and reported in seconds. | time from opening mouth to successful placement (4 hours) |
| Sore Throat | Participants will be asked upon discharge from recovery room (approximately 8 hours post surgery) to rate the soreness of their throat on a numerical rating scale of 0-10 (0 being no soreness and 10 being maximum imaginable soreness). Participants will be asked to rate throat soreness again via phone call approximately 24 hours after surgery. |
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Inclusion Criteria:
- undergoing outpatient ambulatory surgery under general anesthesia that is amenable to using a laryngeal mask airway
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Hutchins, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Igel Larnygeal Mask Airway | Group 1 will receive the I-Gel Laryngeal Mask Airway for airway maintenance during general anesthesia I-Gel Laryngeal Mask Airway: The I-Gel Laryngeal Mask Airway is a medical device that keeps a patient's airway open during anaesthesia or unconsciousness. |
| FG001 | Ambu Auragain Laryngeal Mask Airway | Group 2 will receive the Ambu Auragain Laryngeal Mask Airway for airway maintenance during general anesthesia Ambu Auragain Laryngeal Mask Airway: The Ambu Auragain Laryngeal Mask Airway is a medical device that keeps a patient's airway open during anaesthesia or unconsciousness. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Igel Larnygeal Mask Airway | Group 1 will receive the I-Gel Laryngeal Mask Airway for airway maintenance during general anesthesia I-Gel Laryngeal Mask Airway: The I-Gel Laryngeal Mask Airway is a medical device that keeps a patient's airway open during anaesthesia or unconsciousness. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Oropharyngeal Leak Pressure (OLP) | OLP will be measured immediately after insertion. This will be accomplished by closing the expiratory valve while keeping fresh gas flow at 3 liters/minute until equilibrium is reached. Pressure will be reported in cmH2O. | Posted | Mean | Standard Deviation | cm H20 | immediately after placement |
|
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Total Number of Participants at Risk for serious and other [non-serious] adverse events and all-cause mortality were not collected or assessed as part of the study
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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 | Igel Larnygeal Mask Airway | Group 1 will receive the I-Gel Laryngeal Mask Airway for airway maintenance during general anesthesia I-Gel Laryngeal Mask Airway: The I-Gel Laryngeal Mask Airway is a medical device that keeps a patient's airway open during anaesthesia or unconsciousness. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jacob Hutchins, MD | University of Minnesota | 612-624-9990 | hutc0079@umn.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 | Mar 8, 2021 | Oct 26, 2022 | Prot_SAP_000.pdf |
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Patients who are scheduled for elective ambulatory surgery under general anesthesia will be randomized to one of two groups. Group 1 will receive an I-gel laryngeal mask airway (LMA) and group 2 will receive an Ambu Auragain LMA.
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| Ambu Auragain Laryngeal Mask Airway | Device | The Ambu Auragain Laryngeal Mask Airway is a medical device that keeps a patient's airway open during anaesthesia or unconsciousness. |
|
| Pain right before discharge from pacu (8 hours) |
| Sore Throat | Participants will be asked upon discharge from recovery room (approximately 8 hours post surgery) to rate the soreness of their throat on a numerical rating scale of 0-10 (0 being no soreness and 10 being maximum imaginable soreness). Participants will be asked to rate throat soreness again via phone call approximately 24 hours after surgery. | 24 hours post-surgery |
| Ambu Auragain Laryngeal Mask Airway |
Group 2 will receive the Ambu Auragain Laryngeal Mask Airway for airway maintenance during general anesthesia Ambu Auragain Laryngeal Mask Airway: The Ambu Auragain Laryngeal Mask Airway is a medical device that keeps a patient's airway open during anaesthesia or unconsciousness. |
| 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 |
|
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| Secondary | Time to Placement | Time required to place laryngeal mask airway will be measured and reported in seconds. | Posted | Median | Inter-Quartile Range | seconds | time from opening mouth to successful placement (4 hours) |
|
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| Secondary | Sore Throat | Participants will be asked upon discharge from recovery room (approximately 8 hours post surgery) to rate the soreness of their throat on a numerical rating scale of 0-10 (0 being no soreness and 10 being maximum imaginable soreness). Participants will be asked to rate throat soreness again via phone call approximately 24 hours after surgery. | Posted | Median | Inter-Quartile Range | numerical rating scale | Pain right before discharge from pacu (8 hours) |
|
|
|
| Secondary | Sore Throat | Participants will be asked upon discharge from recovery room (approximately 8 hours post surgery) to rate the soreness of their throat on a numerical rating scale of 0-10 (0 being no soreness and 10 being maximum imaginable soreness). Participants will be asked to rate throat soreness again via phone call approximately 24 hours after surgery. | Posted | Median | Inter-Quartile Range | numerical rating scale | 24 hours post-surgery |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Ambu Auragain Laryngeal Mask Airway | Group 2 will receive the Ambu Auragain Laryngeal Mask Airway for airway maintenance during general anesthesia Ambu Auragain Laryngeal Mask Airway: The Ambu Auragain Laryngeal Mask Airway is a medical device that keeps a patient's airway open during anaesthesia or unconsciousness. | 0 | 0 | 0 | 0 | 0 | 0 |
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