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Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01141660
First received: June 7, 2010
Last updated: February 21, 2012
Last verified: March 2011
History of Changes
Results First Received: November 10, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Laryngeal Mask Airway
Tonsillectomy
Interventions: Device: Endotracheal Tube
Device: Laryngeal mask airway

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Endotracheal Tube     Laryngeal Mask Airway  
STARTED     71     60  
COMPLETED     71     48  
NOT COMPLETED     0     12  
Physician Decision                 0                 12  



  Baseline Characteristics
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Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    Endotracheal Tube     Laryngeal Mask Airway     Total  
Number of Participants  
[units: participants]
 		  71     60     131  
Age  
[units: participants]
 		     
<=18 years     71     60     131  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  5.5  ± 2.5     5.69  ± 2.3     5.6  ± 2.4  
Gender  
[units: participants]
 		     
Female     31     25     56  
Male     40     35     75  
Region of Enrollment  
[units: participants]
 		     
United States     71     60     131  



  Outcome Measures

1.  Primary:   Number of Participants With Laryngospasm   [ Time Frame: 2 years ]
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2.  Secondary:   Anesthetic and Recovery Times   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Cristina Baldassari
Organization: Eastern Virginia Medical School
phone: 7576689853
e-mail: baldassc@yahoo.com


Publications:


Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01141660     History of Changes
Other Study ID Numbers: VCU IRB# HM10692
Study First Received: June 7, 2010
Results First Received: November 10, 2010
Last Updated: February 21, 2012
Health Authority: United States: Institutional Review Board