Anesthesia, Surgery
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEI-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.
DEVICEAmbu 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.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
\- undergoing outpatient ambulatory surgery under general anesthesia that is amenable to using a laryngeal mask airway
Exclusion criteria
* non-English speaking patients * patients with abnormal airway anatomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oropharyngeal Leak Pressure (OLP) | immediately after placement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Placement | time from opening mouth to successful placement (4 hours) | Time required to place laryngeal mask airway will be measured and reported in seconds. |
| Sore Throat | Pain right before discharge from pacu (8 hours) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 70 |
| 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. | 70 |
| Total | 140 |
Baseline characteristics
| Characteristic | Igel Larnygeal Mask Airway | Ambu Auragain Laryngeal Mask Airway | Total |
|---|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 16.9 | 44.6 years STANDARD_DEVIATION 19 | 44.8 years STANDARD_DEVIATION 17.9 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 27 Participants | 34 Participants | 61 Participants |
| Sex: Female, Male Male | 43 Participants | 36 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: immediately after placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Igel Larnygeal Mask Airway | Oropharyngeal Leak Pressure (OLP) | 20.9 cm H20 | Standard Deviation 6 |
| Ambu Auragain Laryngeal Mask Airway | Oropharyngeal Leak Pressure (OLP) | 22.6 cm H20 | Standard Deviation 5.5 |
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.
Time frame: Pain right before discharge from pacu (8 hours)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Igel Larnygeal Mask Airway | Sore Throat | 0 numerical rating scale |
| Ambu Auragain Laryngeal Mask Airway | Sore Throat | 0 numerical rating scale |
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.
Time frame: 24 hours post-surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Igel Larnygeal Mask Airway | Sore Throat | 0 numerical rating scale |
| Ambu Auragain Laryngeal Mask Airway | Sore Throat | 0 numerical rating scale |
Secondary
Time to Placement
Time required to place laryngeal mask airway will be measured and reported in seconds.
Time frame: time from opening mouth to successful placement (4 hours)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Igel Larnygeal Mask Airway | Time to Placement | 8.9 seconds |
| Ambu Auragain Laryngeal Mask Airway | Time to Placement | 30.4 seconds |