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Laryngeal Mask Airway in Pediatric Adenotonsillectomy (LMA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Eastern Virginia Medical School
Sponsor:
Information provided by (Responsible Party):
Cristina Baldassari M.D., Eastern Virginia Medical School
ClinicalTrials.gov Identifier:
NCT01695980
First received: September 24, 2012
Last updated: August 28, 2014
Last verified: February 2014
  Purpose

The study will compare how often the tubing kinks when a LMA (laryngeal mask airway) with modified retractor is used compared to use of an endotracheal tube (ETT) and non modified retractor is used.


Condition Intervention
Sleep Apnea, Obstructive
Tonsillitis
Procedure: ETT with non modified retractor
Other: LMA with modified retractor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laryngeal Mask Airway in Pediatric Adenotonsillectomy

Resource links provided by NLM:


Further study details as provided by Eastern Virginia Medical School:

Primary Outcome Measures:
  • To determine the number of participants with adverse events with use of LMA and ETT during adenotonsillectomy. [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • To determine total length of procedure and recovery time with use the LMA. [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: August 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
adenotonsillectomy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • requiring adenotonsillectomy for Obstructive sleep apnea or chronic tonsillitis between the ages of 2-16

Exclusion Criteria:

  • children with BMI >35
  • unwillingness to comply with study procedures
  • children with craniofacial anomalies/abnormalities which will interfere with mask placement
  • children under 2 or over 16
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695980

Contacts
Contact: Chrisina Baldassari, MD 757-668-6200 cristina.baldassari@chkd.org

Locations
United States, Virginia
Children's Hospital of the King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Blake Kimbrell, MD    757-388-6200    kimbrebs@evms.edu   
Principal Investigator: Christina Baldassari, MD         
Sponsors and Collaborators
Eastern Virginia Medical School
Investigators
Principal Investigator: Christina Baldassari, MD Eastern Virginia Medical School
  More Information

No publications provided

Responsible Party: Cristina Baldassari M.D., Assistant Professor, Pediatric Otolaryngology, Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT01695980     History of Changes
Other Study ID Numbers: version 4 25Jun2012
Study First Received: September 24, 2012
Last Updated: August 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Eastern Virginia Medical School:
adenotonsillectomy

Additional relevant MeSH terms:
Tonsillitis
Sleep Apnea, Obstructive
Apnea
Dyssomnias
Nervous System Diseases
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Pharyngitis
Respiration Disorders
Respiratory Tract Diseases
Respiratory Tract Infections
Sleep Apnea Syndromes
Sleep Disorders
Sleep Disorders, Intrinsic
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 23, 2014