Trial Outcomes & Findings for Air-Q® SP Versus Air-Q® and I-gel: A Randomized Clinical Trial (NCT NCT01592760)

Last Updated: 2017-03-17

Results Overview

Airway seal pressure is defined as the pressure in cmH2O at which the needle of a manometer attached to the anesthesia circuit reaches equilibration, associated with an audible air leak from the subject's oropharynx or gastric insufflation, limited to a maximum pressure of 40 cmH2O. It is measured with the subject's head and neck in neutral position, the expiratory valve on the anesthesia machine closed, and the fresh gas flow set to five liters per minute.

Recruitment status

COMPLETED

Study phase

Target enrollment

225 participants

Primary outcome timeframe

Measured within 5 minutes after device placement/study initiation

Results posted on

2017-03-17

Participant Flow

Participant milestones

Participant milestones
Measure	Air-Q Subjects randomized to receive air-Q for airway maintenance under general anesthesia.	Air-Q SP Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.	I-gel Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
Perioperative to Discharge STARTED	90	90	45
Perioperative to Discharge COMPLETED	90	90	45
Perioperative to Discharge NOT COMPLETED	0	0	0
24-hour Follow-Up STARTED	90	90	45
24-hour Follow-Up COMPLETED	86	87	43
24-hour Follow-Up NOT COMPLETED	4	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Air-Q Subjects randomized to receive air-Q for airway maintenance under general anesthesia.	Air-Q SP Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.	I-gel Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
24-hour Follow-Up Lost to Follow-up	4	3	2

Baseline Characteristics

Air-Q® SP Versus Air-Q® and I-gel: A Randomized Clinical Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Air-Q n=90 Participants air-Q Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA) air-Q SP: air-Q SP placement for airway maintenance.	Air-Q SP n=90 Participants air-Q Self-Pressurizing Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA) air-Q SP: air-Q SP placement for airway maintenance.	I-gel n=45 Participants i-gel, sizes 3, 4, and 5 (Intersurgical Inc., Liverpool, NY, USA) i-gel: i-gel placement for airway maintenance.	Total n=225 Participants Total of all reporting groups
Age, Continuous	42 years STANDARD_DEVIATION 14 • n=99 Participants	45 years STANDARD_DEVIATION 16 • n=107 Participants	40 years STANDARD_DEVIATION 15 • n=206 Participants	43 years STANDARD_DEVIATION 15 • n=7 Participants
Sex: Female, Male Female	32 Participants n=99 Participants	41 Participants n=107 Participants	15 Participants n=206 Participants	88 Participants n=7 Participants
Sex: Female, Male Male	58 Participants n=99 Participants	49 Participants n=107 Participants	30 Participants n=206 Participants	137 Participants n=7 Participants
Body Mass Index	28 kg/m^2 STANDARD_DEVIATION 6 • n=99 Participants	27 kg/m^2 STANDARD_DEVIATION 5 • n=107 Participants	27 kg/m^2 STANDARD_DEVIATION 5 • n=206 Participants	27 kg/m^2 STANDARD_DEVIATION 5 • n=7 Participants
Mallampati Score Class 1	41 participants n=99 Participants	33 participants n=107 Participants	17 participants n=206 Participants	91 participants n=7 Participants
Mallampati Score Class 2	43 participants n=99 Participants	42 participants n=107 Participants	25 participants n=206 Participants	110 participants n=7 Participants
Mallampati Score Class 3	4 participants n=99 Participants	11 participants n=107 Participants	2 participants n=206 Participants	17 participants n=7 Participants
Mallampati Score Class 4	0 participants n=99 Participants	1 participants n=107 Participants	1 participants n=206 Participants	2 participants n=7 Participants
Mallampati Score Missing Data	2 participants n=99 Participants	3 participants n=107 Participants	0 participants n=206 Participants	5 participants n=7 Participants
Device Size 3	0 participants n=99 Participants	0 participants n=107 Participants	2 participants n=206 Participants	2 participants n=7 Participants
Device Size 3.5	32 participants n=99 Participants	42 participants n=107 Participants	0 participants n=206 Participants	74 participants n=7 Participants
Device Size 4	0 participants n=99 Participants	0 participants n=107 Participants	35 participants n=206 Participants	35 participants n=7 Participants
Device Size 4.5	58 participants n=99 Participants	48 participants n=107 Participants	0 participants n=206 Participants	106 participants n=7 Participants
Device Size 5	0 participants n=99 Participants	0 participants n=107 Participants	7 participants n=206 Participants	7 participants n=7 Participants
Device Size Missing Data	0 participants n=99 Participants	0 participants n=107 Participants	1 participants n=206 Participants	1 participants n=7 Participants
Procedure Type Orthopedic	72 participants n=99 Participants	70 participants n=107 Participants	35 participants n=206 Participants	177 participants n=7 Participants
Procedure Type General Surgery	7 participants n=99 Participants	10 participants n=107 Participants	6 participants n=206 Participants	23 participants n=7 Participants
Procedure Type Other	11 participants n=99 Participants	10 participants n=107 Participants	4 participants n=206 Participants	25 participants n=7 Participants

PRIMARY outcome

Timeframe: Measured within 5 minutes after device placement/study initiation

Outcome measures

Outcome measures
Measure	Air-Q n=90 Participants Subjects randomized to receive air-Q for airway maintenance under general anesthesia.	Air-Q SP n=90 Participants Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.	I-gel n=45 Participants Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
Airway Seal Pressure After Device Placement	28 cmH2O Standard Deviation 6	27 cmH2O Standard Deviation 8	24 cmH2O Standard Deviation 8

SECONDARY outcome

Timeframe: Measured at device placement/study initiation

Device placement time is the time measured in seconds from when the study investigator picks up the airway device to confirmation of ventilation by the presence of an adequate end-tidal carbon dioxide tracing on the monitor.

Outcome measures

Outcome measures
Measure	Air-Q n=90 Participants Subjects randomized to receive air-Q for airway maintenance under general anesthesia.	Air-Q SP n=90 Participants Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.	I-gel n=45 Participants Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
Device Placement Time	25 seconds Standard Deviation 11	19 seconds Standard Deviation 9	21 seconds Standard Deviation 13

SECONDARY outcome

Timeframe: Measured at the time of attempted study device placement immediately after the induction of general anesthesia

Device placement success rate is defined as the proportion of devices successfully placed within three attempts at device placement.

Outcome measures

Outcome measures
Measure	Air-Q n=90 Participants Subjects randomized to receive air-Q for airway maintenance under general anesthesia.	Air-Q SP n=90 Participants Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.	I-gel n=45 Participants Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
Device Placement Success Rate Attempt 1	83 participants	84 participants	41 participants
Device Placement Success Rate Attempt 2	6 participants	3 participants	4 participants
Device Placement Success Rate Attempt 3	1 participants	3 participants	0 participants

SECONDARY outcome

Timeframe: Reported by the device operator at the time successful device placement is recorded.

Device ease of insertion is graded as either easy, slightly difficult, difficult, or impossible. The outcome measure is the proportion of successful study device placements recorded as easy versus slightly difficult versus difficult versus impossible.

Outcome measures

Outcome measures
Measure	Air-Q n=90 Participants Subjects randomized to receive air-Q for airway maintenance under general anesthesia.	Air-Q SP n=90 Participants Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.	I-gel n=45 Participants Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
Device Ease of Insertion Easy	73 participants	77 participants	38 participants
Device Ease of Insertion Slight Difficulty	16 participants	11 participants	7 participants
Device Ease of Insertion Moderate Difficulty	0 participants	0 participants	0 participants
Device Ease of Insertion Difficult	1 participants	1 participants	0 participants
Device Ease of Insertion Missing Data	0 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Measured within 5 minutes of successful study device placement

Device position in relation to the vocal cords is assessed with a flexible fiberoptic camera and graded as follows: 1 = full view of the vocal cords, 2 = partial view of the vocal cords including the arytenoids, 3 = view of the epiglottis only, and 4 = other (device cuff, pharynx or other structures).

Outcome measures

Outcome measures
Measure	Air-Q n=90 Participants Subjects randomized to receive air-Q for airway maintenance under general anesthesia.	Air-Q SP n=90 Participants Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.	I-gel n=45 Participants Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
Device Position in Relation to the Vocal Cords 1	62 participants	71 participants	28 participants
Device Position in Relation to the Vocal Cords 2	6 participants	4 participants	10 participants
Device Position in Relation to the Vocal Cords 3	14 participants	7 participants	4 participants
Device Position in Relation to the Vocal Cords 4	8 participants	8 participants	3 participants

SECONDARY outcome

Timeframe: Measured between successful device placement and device removal for any reason, approximately 2 hours

Device Use Time is the time recorded to the nearest minute of the period bounded by the time the device placement was determined to be adequate in the study subject to its withdrawal from the study subject.

Outcome measures

Outcome measures
Measure	Air-Q n=90 Participants Subjects randomized to receive air-Q for airway maintenance under general anesthesia.	Air-Q SP n=90 Participants Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.	I-gel n=45 Participants Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
Device Use Time (Min)	60 minutes Standard Deviation 34	65 minutes Standard Deviation 40	70 minutes Standard Deviation 41

SECONDARY outcome

Timeframe: Measured within 5 minutes of device placement/study initiation

Gastric insufflation is present when audible air sounds are heard by stethoscope over the subject's epigastrium.

Outcome measures

Outcome measures
Measure	Air-Q n=90 Participants Subjects randomized to receive air-Q for airway maintenance under general anesthesia.	Air-Q SP n=90 Participants Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.	I-gel n=45 Participants Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
Incidence of Gastric Insufflation	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Measured between successful device placement and device removal for any reason.

Gastric aspiration is present when gross gastric contents or bile is observed on or within the device or within the subject's oropharynx. The outcome is the proportion of study subjects in whom the outcome measure was observed.

Outcome measures

Outcome measures
Measure	Air-Q n=90 Participants Subjects randomized to receive air-Q for airway maintenance under general anesthesia.	Air-Q SP n=90 Participants Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.	I-gel n=45 Participants Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
Incidence of Gastric Aspiration	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Measured in the post-anesthesia care unit/recovery room within 15 minutes after device removal

Oropharyngeal injury is defined as a new lip, tongue, buccal, or pharyngeal abrasion or laceration or dental damage observed in the immediate recovery area after use of a study device.

Outcome measures

Outcome measures
Measure	Air-Q n=90 Participants Subjects randomized to receive air-Q for airway maintenance under general anesthesia.	Air-Q SP n=90 Participants Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.	I-gel n=45 Participants Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
Incidence of Oropharyngeal Injury	2 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Reported by the device operator at the time of device removal

Excellent, good, fair, or inadequate. Scale defined by clinical measures and observations.

Outcome measures

Outcome measures
Measure	Air-Q n=90 Participants Subjects randomized to receive air-Q for airway maintenance under general anesthesia.	Air-Q SP n=90 Participants Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.	I-gel n=45 Participants Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
Overall Clinical Usefulness Excellent	56 participants	65 participants	24 participants
Overall Clinical Usefulness Good	6 participants	4 participants	1 participants
Overall Clinical Usefulness Fair	27 participants	21 participants	20 participants
Overall Clinical Usefulness Inadequate	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Measured prior to discharge from phase II of the post-anesthesia care unit/recovery room

Perioperative oropharyngolaryngeal morbidity is assessed by the subject's response to standardized questions regarding oropharyngeal complaints.

Outcome measures

Outcome measures
Measure	Air-Q n=90 Participants Subjects randomized to receive air-Q for airway maintenance under general anesthesia.	Air-Q SP n=90 Participants Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.	I-gel n=45 Participants Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
Oropharyngolaryngeal Morbidity at Discharge Sore Throat	38 participants	28 participants	7 participants
Oropharyngolaryngeal Morbidity at Discharge Pain on Swallowing	29 participants	20 participants	3 participants
Oropharyngolaryngeal Morbidity at Discharge Pain in Jaw	1 participants	0 participants	0 participants
Oropharyngolaryngeal Morbidity at Discharge Pain in Mouth	2 participants	1 participants	0 participants
Oropharyngolaryngeal Morbidity at Discharge Pain on Speaking	2 participants	3 participants	0 participants
Oropharyngolaryngeal Morbidity at Discharge Tongue Swelling	2 participants	2 participants	1 participants
Oropharyngolaryngeal Morbidity at Discharge Tongue Numbness	2 participants	2 participants	1 participants
Oropharyngolaryngeal Morbidity at Discharge Face Numbness	2 participants	2 participants	0 participants
Oropharyngolaryngeal Morbidity at Discharge Lip Numbness	4 participants	3 participants	1 participants
Oropharyngolaryngeal Morbidity at Discharge Ear Pain	2 participants	4 participants	0 participants
Oropharyngolaryngeal Morbidity at Discharge Hearing Change	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Measured at 24 hours after device placement/study initiation

Perioperative oropharyngolaryngeal morbidity is assessed by the subject's response to standardized questions regarding oropharyngeal complaints.

Outcome measures

Outcome measures
Measure	Air-Q n=86 Participants Subjects randomized to receive air-Q for airway maintenance under general anesthesia.	Air-Q SP n=87 Participants Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.	I-gel n=43 Participants Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
Oropharyngolaryngeal Morbidity at 24 Hours Post-operatively Sore Throat	42 participants	50 participants	15 participants
Oropharyngolaryngeal Morbidity at 24 Hours Post-operatively Pain on Swallowing	37 participants	37 participants	7 participants
Oropharyngolaryngeal Morbidity at 24 Hours Post-operatively Pain in Jaw	3 participants	2 participants	2 participants
Oropharyngolaryngeal Morbidity at 24 Hours Post-operatively Pain in Mouth	6 participants	1 participants	1 participants
Oropharyngolaryngeal Morbidity at 24 Hours Post-operatively Pain on Speaking	4 participants	2 participants	2 participants
Oropharyngolaryngeal Morbidity at 24 Hours Post-operatively Tongue Swelling	1 participants	1 participants	0 participants
Oropharyngolaryngeal Morbidity at 24 Hours Post-operatively Tongue Numbness	1 participants	0 participants	3 participants
Oropharyngolaryngeal Morbidity at 24 Hours Post-operatively Face Numbness	0 participants	0 participants	0 participants
Oropharyngolaryngeal Morbidity at 24 Hours Post-operatively Lip Numbness	4 participants	2 participants	1 participants
Oropharyngolaryngeal Morbidity at 24 Hours Post-operatively Ear Pain	1 participants	2 participants	1 participants
Oropharyngolaryngeal Morbidity at 24 Hours Post-operatively Hearing Change	1 participants	1 participants	1 participants

Adverse Events

Air-Q

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Air-Q SP

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

I-gel

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Air-Q n=90 participants at risk Subjects randomized to receive air-Q for airway maintenance under general anesthesia.	Air-Q SP n=90 participants at risk Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.	I-gel n=45 participants at risk Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
Injury, poisoning and procedural complications Lip swelling/bruise	0.00% 0/90 • Up to 24 hours post-device use Note: "Other" adverse events include any subject experiencing any non-serious adverse event not included as a secondary outcome measure on post-procedure questioning at any time point up to 24 hours post-device use.	1.1% 1/90 • Number of events 1 • Up to 24 hours post-device use Note: "Other" adverse events include any subject experiencing any non-serious adverse event not included as a secondary outcome measure on post-procedure questioning at any time point up to 24 hours post-device use.	0.00% 0/45 • Up to 24 hours post-device use Note: "Other" adverse events include any subject experiencing any non-serious adverse event not included as a secondary outcome measure on post-procedure questioning at any time point up to 24 hours post-device use.
Injury, poisoning and procedural complications Oropharyngeal bruise	1.1% 1/90 • Number of events 1 • Up to 24 hours post-device use Note: "Other" adverse events include any subject experiencing any non-serious adverse event not included as a secondary outcome measure on post-procedure questioning at any time point up to 24 hours post-device use.	0.00% 0/90 • Up to 24 hours post-device use Note: "Other" adverse events include any subject experiencing any non-serious adverse event not included as a secondary outcome measure on post-procedure questioning at any time point up to 24 hours post-device use.	0.00% 0/45 • Up to 24 hours post-device use Note: "Other" adverse events include any subject experiencing any non-serious adverse event not included as a secondary outcome measure on post-procedure questioning at any time point up to 24 hours post-device use.
Injury, poisoning and procedural complications Oropharyngeal heme/blood	0.00% 0/90 • Up to 24 hours post-device use Note: "Other" adverse events include any subject experiencing any non-serious adverse event not included as a secondary outcome measure on post-procedure questioning at any time point up to 24 hours post-device use.	0.00% 0/90 • Up to 24 hours post-device use Note: "Other" adverse events include any subject experiencing any non-serious adverse event not included as a secondary outcome measure on post-procedure questioning at any time point up to 24 hours post-device use.	2.2% 1/45 • Number of events 1 • Up to 24 hours post-device use Note: "Other" adverse events include any subject experiencing any non-serious adverse event not included as a secondary outcome measure on post-procedure questioning at any time point up to 24 hours post-device use.

Additional Information

Richard E. Galgon, MD, MS

Universtiy of Wisconsin School of Medicine and Public Health

Phone: 608-263-8100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place