Laryngeal Mask Airway in Pediatric Adenotonsillectomy (LMA)
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|ClinicalTrials.gov Identifier: NCT01695980|
Recruitment Status : Recruiting
First Posted : September 28, 2012
Last Update Posted : February 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea, Obstructive Tonsillitis||Procedure: ETT with non modified retractor Other: LMA with modified retractor||Not Applicable|
The laryngeal mask airway (LMA)is a device used to secure the airway of patients during general anesthesia. This device is routinely used for anesthesia in elective head and neck surgeries, including adenotonsillectomy. In this study, the efficacy of the LMA will be studied as it pertains to operative times and cost.
The child will be randomized into either the LMA group or the ETT group.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Laryngeal Mask Airway in Pediatric Adenotonsillectomy|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: LMA with modified retractor
LMA with modified retractor
Other: LMA with modified retractor
LMA with modified retractor
Active Comparator: ETT with non modified retractor
ETT with non modified retractor
Procedure: ETT with non modified retractor
- To determine the number of participants with adverse events with use of LMA and ETT during adenotonsillectomy. [ Time Frame: one year ]Mouth gag equipment is used for the LMA and the ETT. A modified tongue depressor is used with the LMA and a non-modified tongue depressor is used with the ETT. Data will be collected in regards to the rate of kinking/obstruction of the tubing with each type of equipment to determine which option is the best for use in adenotonsillectomy.
- To determine total length of procedure and recovery time with use the LMA. [ Time Frame: One year ]Does the rate of kinking/obstruction of the tubing cause prolonged procedure time and additional issues for anesthesia and the subsequent recovery of the patient.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695980
|Contact: Chrisina Baldassari, MDfirstname.lastname@example.org|
|United States, Virginia|
|Children's Hospital of the King's Daughters||Recruiting|
|Norfolk, Virginia, United States, 23507|
|Contact: Blake Kimbrell, MD 757-388-6200 email@example.com|
|Principal Investigator: Christina Baldassari, MD|
|Principal Investigator:||Christina Baldassari, MD||Eastern Virginia Medical School|