Trial Outcomes & Findings for Comparison of ProSeal Laryngeal Mask Airway to Laryngeal Mask Airway Supreme (NCT NCT00836095)

Results Overview

The insertion time will be the measured time that it takes the anesthesiologist to insert the airway and verify ventilation of the patient's airway. Data reported will be time in seconds ± the standard deviation.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

52 participants

Primary outcome timeframe

During intubation of the patient

Results posted on

2016-04-15

Participant Flow

Participant milestones

Participant milestones
Measure	Supreme LMA Supreme Laryngeal mask airway: The Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant. The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.	Proseal LMA Proseal laryngeal mask airway: The Proseal is a multiple use, variant of the laryngeal mask airway. The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.
Overall Study STARTED	22	30
Overall Study COMPLETED	22	27
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Supreme LMA Supreme Laryngeal mask airway: The Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant. The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.	Proseal LMA Proseal laryngeal mask airway: The Proseal is a multiple use, variant of the laryngeal mask airway. The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.
Overall Study Physician Decision	0	3

Baseline Characteristics

Comparison of ProSeal Laryngeal Mask Airway to Laryngeal Mask Airway Supreme

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supreme LMA n=22 Participants The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist. Supreme Laryngeal mask airway: Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant.	Proseal LMA n=30 Participants The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist. Proseal laryngeal mask airway: Proseal is a multiple use, variant of the laryngeal mask airway	Total n=52 Participants Total of all reporting groups
Age, Continuous	49 years STANDARD_DEVIATION 14 • n=93 Participants	41 years STANDARD_DEVIATION 14 • n=4 Participants	45 years STANDARD_DEVIATION 14 • n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	18 Participants n=4 Participants	32 Participants n=27 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	12 Participants n=4 Participants	20 Participants n=27 Participants

PRIMARY outcome

Timeframe: During intubation of the patient

The insertion time will be the measured time that it takes the anesthesiologist to insert the airway and verify ventilation of the patient's airway. Data reported will be time in seconds ± the standard deviation.

Outcome measures

Outcome measures
Measure	Supreme LMA n=22 Participants Supreme Laryngeal mask airway: The Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.	Proseal LMA n=27 Participants Proseal laryngeal mask airway: The Proseal is a multiple use, variant of the laryngeal mask airway The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.
Insertion Time	26 seconds Standard Deviation 10	18 seconds Standard Deviation 6

SECONDARY outcome

Timeframe: During intubation of the patient

Insertion success rate will be reported as the number of patients for whom the airway device was successfully inserted and ventilation was verified.

Outcome measures

Outcome measures
Measure	Supreme LMA n=22 Participants Supreme Laryngeal mask airway: The Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.	Proseal LMA n=27 Participants Proseal laryngeal mask airway: The Proseal is a multiple use, variant of the laryngeal mask airway The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.
Insertion Success Rate	22 Number of successful airway insertions	27 Number of successful airway insertions

Adverse Events

Supreme 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

Sonia Vaida MD, Professor of Anesthesiology

Penn State Milton S. Hershey Medical Center

Phone: 7175318433

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place