Trial Outcomes & Findings for Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy (NCT NCT01141660)

NCT ID: NCT01141660

Last Updated: 2017-11-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 131 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2017-11-13

Participant Flow

Participant milestones

Measure	Endotracheal Tube Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.	Laryngeal Mask Airway Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
Overall Study STARTED	71	60
Overall Study COMPLETED	71	48
Overall Study NOT COMPLETED	0	12

Reasons for withdrawal

Measure	Endotracheal Tube Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.	Laryngeal Mask Airway Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
Overall Study Physician Decision	0	12

Baseline Characteristics

Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy

Baseline characteristics by cohort

Measure	Endotracheal Tube n=71 Participants Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.	Laryngeal Mask Airway n=60 Participants Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.	Total n=131 Participants Total of all reporting groups
Age, Categorical <=18 years	71 Participants n=5 Participants	60 Participants n=7 Participants	131 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	5.5 years STANDARD_DEVIATION 2.5 • n=5 Participants	5.69 years STANDARD_DEVIATION 2.3 • n=7 Participants	5.6 years STANDARD_DEVIATION 2.4 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	25 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	35 Participants n=7 Participants	75 Participants n=5 Participants
Region of Enrollment United States	71 participants n=5 Participants	60 participants n=7 Participants	131 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Measure	Endotracheal Tube n=71 Participants Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.	Laryngeal Mask Airway n=60 Participants Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
Number of Participants With Laryngospasm	8 Participants	6 Participants

SECONDARY outcome

Timeframe: After surgery

Outcome measures

Measure	Endotracheal Tube n=71 Participants Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.	Laryngeal Mask Airway n=60 Participants Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
Postanesthesia Recovery Times	95.59 minutes Standard Deviation 77.72	83.50 minutes Standard Deviation 58.91

Adverse Events

Endotracheal Tube

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Cristina Baldassari

Eastern Virginia Medical School

Phone: 7576689853

Email: baldassc@yahoo.com

Results disclosure agreements

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