Laryngeal Mask Airway in Pediatric Adenotonsillectomy (LMA)
This study is currently recruiting participants.
Verified March 2013 by Eastern Virginia Medical School
Sponsor:
Eastern Virginia Medical School
Information provided by (Responsible Party):
Cristina Baldassari M.D., Eastern Virginia Medical School
ClinicalTrials.gov Identifier:
NCT01695980
First received: September 24, 2012
Last updated: March 1, 2013
Last verified: March 2013
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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: | December 2013 |
| Estimated Primary Completion Date: | August 2013 (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
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: | March 1, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Eastern Virginia Medical School:
|
adenotonsillectomy |
Additional relevant MeSH terms:
|
Tonsillitis Sleep Apnea Syndromes Sleep Apnea, Obstructive Apnea Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Dyssomnias |
Sleep Disorders Nervous System Diseases Pharyngitis Pharyngeal Diseases Stomatognathic Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013