Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy

• Sponsor: Virginia Commonwealth University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01141660
• Collaborator: (none)
• Enrollment: 131
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 6.5

Study Details

Study Description

Brief Summary

The aim of the current study is to compare the use of laryngeal mask airway (LMA) and endotracheal tube (ETT) in pediatric adenotonsillectomy. The primary objective is to assess the incidence of post-operative laryngospasm between the LMA and ETT. The investigators also sought to compare anesthetic, operative, and recovery times in the LMA and ETT groups. We hypothesized that the LMA would be a safe efficient alternative to the ETT.

Condition or Disease	Intervention/Treatment	Phase
Laryngeal Mask Airway; Tonsillectomy	Device: Endotracheal Tube; Device: Laryngeal mask airway	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 131 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Endotracheal Tube Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.	Device: Endotracheal Tube; Patients randomized to either Laryngeal Mask Airway or Endotracheal tube prior to undergoing adenotonsillectomy.; Other Names: ETT Endotracheal intubation
Experimental: Laryngeal Mask Airway Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.	Device: Laryngeal mask airway; Randomized to either Laryngeal mask airway or endotracheal tube; Other Names: LMA

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Laryngospasm [2 years]

Secondary Outcome Measures

1. Postanesthesia Recovery Times [After surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Children 2 to 12 years of age undergoing elective adenotonsillectomy for obstructive sleep apnea or chronic tonsillitis were included in the study.

Exclusion Criteria:

• Exclusion criteria were as follows: Body Mass Index (BMI) greater than 35 and craniofacial anomalies.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virigina Commonwealth University Medical Center	Richmond	Virginia	United States	23298

Sponsors and Collaborators

• Virginia Commonwealth University

Investigators

• Principal Investigator: Kelley Dodson, MD, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Williams PJ, Bailey PM. Comparison of the reinforced laryngeal mask airway and tracheal intubation for adenotonsillectomy. Br J Anaesth. 1993 Jan;70(1):30-3.

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT01141660
• Other Study ID Numbers: HM10692
• First Posted: Jun 10, 2010
• Last Update Posted: Nov 13, 2017
• Last Verified: Oct 1, 2017

Study Results

Participant Flow

Arm/Group Title	Endotracheal Tube	Laryngeal Mask Airway
Arm/Group Description	Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.	Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
Period Title: Overall Study
STARTED	71	60
COMPLETED	71	48
NOT COMPLETED	0	12

Baseline Characteristics

Arm/Group Title	Endotracheal Tube	Laryngeal Mask Airway	Total
Arm/Group Description	Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.	Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.	Total of all reporting groups
Overall Participants	71	60	131
Age (Count of Participants)
<=18 years	71 100%	60 100%	131 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	5.5 (2.5)	5.69 (2.3)	5.6 (2.4)
Sex: Female, Male (Count of Participants)
Female	31 43.7%	25 41.7%	56 42.7%
Male	40 56.3%	35 58.3%	75 57.3%
Region of Enrollment (participants) [Number]
United States	71 100%	60 100%	131 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Laryngospasm
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Endotracheal Tube	Laryngeal Mask Airway
Arm/Group Description	Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.	Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
Measure Participants	71	60
Number [Participants]	8 11.3%	6 10%

2. Secondary Outcome

Title	Postanesthesia Recovery Times
Time Frame	After surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Endotracheal Tube	Laryngeal Mask Airway
Arm/Group Description	Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.	Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
Measure Participants	71	60
Mean (Standard Deviation) [minutes]	95.59 (77.72)	83.50 (58.91)

Adverse Events

Time Frame	No adverse events collected
Adverse Event Reporting Description	No adverse events collected.
Arm/Group Title	Endotracheal Tube		Laryngeal Mask Airway
Arm/Group Description	Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.		Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
All Cause Mortality
	Endotracheal Tube		Laryngeal Mask Airway
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Endotracheal Tube		Laryngeal Mask Airway
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Endotracheal Tube		Laryngeal Mask Airway
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.