Trial Outcomes & Findings for Air-Q Intubating Laryngeal Airway Versus the Laryngeal Mask Airway (LMA)-Proseal (NCT NCT01328405)

Results Overview

The airway seal pressure will then be assessed by closing the APL valve on the anesthesia machine with a fresh gas flow of 5 liters/minute until an audible leak is observed.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

Intraoperative (day 1)

Results posted on

2015-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	Air-Q LMA Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)	Proseal LMA LMA-Proseal TM (LMA North America, San Diego, Ca.)
Overall Study STARTED	52	48
Overall Study COMPLETED	52	48
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Air-Q Intubating Laryngeal Airway Versus the Laryngeal Mask Airway (LMA)-Proseal

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Air-Q LMA n=52 Participants Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)	Proseal LMA n=48 Participants LMA-Proseal TM (LMA North America, San Diego, Ca.)	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=5 Participants	45 Participants n=7 Participants	96 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	39 years STANDARD_DEVIATION 12 • n=5 Participants	39 years STANDARD_DEVIATION 14 • n=7 Participants	39 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	23 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	25 Participants n=7 Participants	53 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants	48 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: Intraoperative (day 1)

The airway seal pressure will then be assessed by closing the APL valve on the anesthesia machine with a fresh gas flow of 5 liters/minute until an audible leak is observed.

Outcome measures

Outcome measures
Measure	Air-Q LMA n=52 Participants Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)	Proseal LMA n=48 Participants LMA-Proseal TM (LMA North America, San Diego, Ca.)
Airway Seal Pressure	30 cmH2O Standard Deviation 7	30 cmH2O Standard Deviation 6

SECONDARY outcome

Timeframe: Upon LMA removal

At the conclusion of the case, when the patient is breathing on their own and is awake enough, as judged by the anesthesia provider, the LMA will be removed, as would be otherwise done as standard of care. The study LMA will be examined by a data collector for the presence of grossly visible blood or bile, and its presence or absence will be recorded.

Outcome measures

Outcome measures
Measure	Air-Q LMA n=52 Participants Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)	Proseal LMA n=48 Participants LMA-Proseal TM (LMA North America, San Diego, Ca.)
Grossly Visible Blood or Bile on LMA	10 participants	4 participants

SECONDARY outcome

Timeframe: Intraoperative (day 1)

Once the LMA has been placed and secured and the patient is stable from an anesthetic point of view, a flexible fiberoptic camera will be place into the airway tube of the LMA and the view of the patient's vocal cords in relation to the cuff of the LMA will be assessed.

Outcome measures

Outcome measures
Measure	Air-Q LMA n=52 Participants Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)	Proseal LMA n=48 Participants LMA-Proseal TM (LMA North America, San Diego, Ca.)
Glottic View	41 participants with grade 1 glottic view	29 participants with grade 1 glottic view

SECONDARY outcome

Timeframe: Postoperative (day 1) in recovery room

In the recovery area, once the patient is fully awake, as judged by the recovery staff, an observer will administer a standard oral questionnaire to the patient to determine if a sore throat is present.

Outcome measures

Outcome measures
Measure	Air-Q LMA n=52 Participants Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)	Proseal LMA n=48 Participants LMA-Proseal TM (LMA North America, San Diego, Ca.)
Airway Pathology	24 participants	18 participants

SECONDARY outcome

Timeframe: Postoperative Day Two

The patient will be called 24 hours later by the data collector who will administer a standard oral questionnaire to the patient to determine if a sore throat is present.

Outcome measures

Outcome measures
Measure	Air-Q LMA n=43 Participants Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)	Proseal LMA n=39 Participants LMA-Proseal TM (LMA North America, San Diego, Ca.)
Airway Pathology	21 participants	10 participants

Adverse Events

Air-Q LMA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Proseal LMA

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. Kristopher Schroeder

University 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