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Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy

NCT ID: NCT01141660

Last Updated: 2017-11-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Laryngeal Mask Airway Tonsillectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endotracheal Tube

Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.

Group Type EXPERIMENTAL

Endotracheal Tube

Intervention Type DEVICE

Patients randomized to either Laryngeal Mask Airway or Endotracheal tube prior to undergoing adenotonsillectomy.

Laryngeal Mask Airway

Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.

Group Type EXPERIMENTAL

Laryngeal mask airway

Intervention Type DEVICE

Randomized to either Laryngeal mask airway or endotracheal tube

Interventions

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Endotracheal Tube

Patients randomized to either Laryngeal Mask Airway or Endotracheal tube prior to undergoing adenotonsillectomy.

Intervention Type DEVICE

Laryngeal mask airway

Randomized to either Laryngeal mask airway or endotracheal tube

Intervention Type DEVICE

Other Intervention Names

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ETT Endotracheal intubation LMA

Eligibility Criteria

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Inclusion Criteria

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

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kelley Dodson, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virigina Commonwealth University Medical Center

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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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. doi: 10.1093/bja/70.1.30.

Reference Type BACKGROUND
PMID: 8240471 (View on PubMed)

Other Identifiers

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HM10692

Identifier Type: -

Identifier Source: org_study_id