|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01141660 |
|
Date of registration:
|
07/06/2010 |
|
Primary sponsor: |
|
|
Public title:
|
Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy
|
|
Scientific title:
|
Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy |
|
Date of first enrolment:
|
December 2007 |
|
Target sample size:
|
131 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01141660 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Kelley Dodson, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Virginia Commonwealth University |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Children 2 to 12 years of age undergoing elective adenotonsillectomy for obstructive
sleep apnea or chronic tonsillitis were included in the study.
Exclusion Criteria:
- Exclusion criteria were as follows: Body Mass Index (BMI) greater than 35 and
craniofacial anomalies.
Age minimum:
2 Years
Age maximum:
12 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Laryngeal Mask Airway
|
|
Tonsillectomy
|
|
Intervention(s)
|
|
Device: Endotracheal Tube
|
|
Device: Laryngeal mask airway
|
|
Primary Outcome(s)
|
|
Number of Participants With Laryngospasm
[Time Frame: 2 years]
|
|
Secondary Outcome(s)
|
|
Anesthetic and Recovery Times
[Time Frame: 2 years]
|
|
Secondary ID(s)
|
|
VCU IRB# HM10692
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|