Trial Outcomes & Findings for Comparison of Ambu Auragain and I-Gel Supraglottic Airways in Adult Patients at an Ambulatory Surgery Center (NCT NCT04286581)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

148 participants

Primary outcome timeframe

immediately after placement

Results posted on

2022-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	74	74
Overall Study COMPLETED	70	70
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Igel Larnygeal Mask Airway n=70 Participants 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.	Ambu Auragain Laryngeal Mask Airway n=70 Participants 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.	Total n=140 Participants Total of all reporting groups
Age, Continuous	45 years STANDARD_DEVIATION 16.9 • n=70 Participants	44.6 years STANDARD_DEVIATION 19 • n=70 Participants	44.8 years STANDARD_DEVIATION 17.9 • n=140 Participants
Sex: Female, Male Female	27 Participants n=70 Participants	34 Participants n=70 Participants	61 Participants n=140 Participants
Sex: Female, Male Male	43 Participants n=70 Participants	36 Participants n=70 Participants	79 Participants n=140 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Igel Larnygeal Mask Airway n=70 Participants 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.	Ambu Auragain Laryngeal Mask Airway n=70 Participants 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.
Oropharyngeal Leak Pressure (OLP)	20.9 cm H20 Standard Deviation 6	22.6 cm H20 Standard Deviation 5.5

SECONDARY outcome

Timeframe: time from opening mouth to successful placement (4 hours)

Time required to place laryngeal mask airway will be measured and reported in seconds.

Outcome measures

Outcome measures
Measure	Igel Larnygeal Mask Airway n=70 Participants 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.	Ambu Auragain Laryngeal Mask Airway n=70 Participants 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.
Time to Placement	8.9 seconds Interval 5.3 to 18.0	30.4 seconds Interval 24.6 to 42.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Igel Larnygeal Mask Airway n=70 Participants 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.	Ambu Auragain Laryngeal Mask Airway n=70 Participants 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.
Sore Throat	0 numerical rating scale Interval 0.0 to 1.0	0 numerical rating scale Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: 24 hours post-surgery

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.

Outcome measures

Outcome measures
Measure	Igel Larnygeal Mask Airway n=70 Participants 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.	Ambu Auragain Laryngeal Mask Airway n=70 Participants 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.
Sore Throat	0 numerical rating scale Interval 0.0 to 1.0	0 numerical rating scale Interval 0.0 to 1.0

Adverse Events

Igel Larnygeal Mask Airway

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ambu Auragain Laryngeal Mask Airway

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jacob Hutchins, MD

University of Minnesota

Phone: 612-624-9990

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place