We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Laryngeal Mask Airway in Pediatric Adenotonsillectomy (LMA)

This study is currently recruiting participants.
Verified February 2017 by Cristina Baldassari M.D., Eastern Virginia Medical School
Sponsor:
ClinicalTrials.gov Identifier:
NCT01695980
First Posted: September 28, 2012
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Cristina Baldassari M.D., Eastern Virginia Medical School
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laryngeal Mask Airway in Pediatric Adenotonsillectomy

Further study details as provided by Cristina Baldassari M.D., 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 ]
    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 ]
    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: December 2017
Estimated Primary Completion Date: December 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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

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
First Submitted: September 24, 2012
First Posted: September 28, 2012
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Cristina Baldassari M.D., Eastern Virginia Medical School:
adenotonsillectomy

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