Trial Outcomes & Findings for The Rotational Insertion Technique for ProSeal Laryngeal Mask Airway (NCT NCT00966186)

NCT ID: NCT00966186

Last Updated: 2010-08-16

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 120 participants
• Primary outcome timeframe: 5 minute
• Results posted on: 2010-08-16

Participant Flow

Participant milestones

Measure	Standard Technique Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual	Rotational Technique
Overall Study STARTED	60	60
Overall Study COMPLETED	60	60
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Rotational Insertion Technique for ProSeal Laryngeal Mask Airway

Baseline characteristics by cohort

Measure	Standard Technique n=60 Participants Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual	Rotational Technique n=60 Participants	Total n=120 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants	56 Participants n=7 Participants	108 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Age Continuous	49.6 years STANDARD_DEVIATION 12.9 • n=5 Participants	47.4 years STANDARD_DEVIATION 10.7 • n=7 Participants	48.5 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	38 Participants n=7 Participants	75 Participants n=5 Participants
Region of Enrollment Korea, Republic of	60 participants n=5 Participants	60 participants n=7 Participants	120 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 minute

Outcome measures

Measure	Standard Technique n=60 Participants Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual	Rotational Technique n=60 Participants
Success of Insertion at First Attempt	50 participants	60 participants

SECONDARY outcome

Timeframe: 5 min - 4 hours

Outcome measures

Outcome data not reported

Adverse Events

Standard Technique

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rotational Technique

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

Jung-Won Hwang

Seoul National University Bundang Hospital

Phone: 82-31-787-7499

Email: jungwon@snubh.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place