The Safety and Efficacy of Supraglottic Airway Use in Children
NCT ID: NCT02202174
Last Updated: 2015-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
10000 participants
OBSERVATIONAL
2014-06-30
2015-10-31
Brief Summary
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Detailed Description
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Observational data regarding the type of SGA, experience level of practitioner, placement technique, number of placement attempts or placement failure, device failure, and cause of any related peri-operative complications will be prospectively collected.
The data collected in this study will allow the investigators to assess the overall safety and efficacy of SGA use in various medical and surgical procedures performed under general anesthesia in children.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Supraglottic Airway Device
Patients will receive a supraglottic airway device as a primary means of ventilation. The following devices may be used: LMA Unique, LMA ProSeal, LMA Supreme, LMA Flexible, Ambu Aura-I, Ambu Aura Once, Air-Q, I-Gel, or other supraglottic airway device. Choice of the device will be clinician dependent and based on the patients body weight per manufacturer guidelines
Supraglottic Airway Device
Interventions
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Supraglottic Airway Device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Day
18 Years
ALL
Yes
Sponsors
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Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
Responsible Party
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Narasimhan Jagannathan
Primary Investigator; MD
Principal Investigators
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Narasimhan Jagannathan, MD
Role: PRINCIPAL_INVESTIGATOR
Ann & Robert H. Lurie Children's Hospital of Chicago / Stanley Manne Research Institute
Locations
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Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Jagannathan N, Sequera-Ramos L, Sohn L, Wallis B, Shertzer A, Schaldenbrand K. Elective use of supraglottic airway devices for primary airway management in children with difficult airways. Br J Anaesth. 2014 Apr;112(4):742-8. doi: 10.1093/bja/aet411. Epub 2013 Dec 8.
Asai T. Is it safe to use supraglottic airway in children with difficult airways? Br J Anaesth. 2014 Apr;112(4):620-2. doi: 10.1093/bja/aeu005. Epub 2014 Feb 20. No abstract available.
Lopez-Gil M, Brimacombe J, Alvarez M. Safety and efficacy of the laryngeal mask airway. A prospective survey of 1400 children. Anaesthesia. 1996 Oct;51(10):969-72. doi: 10.1111/j.1365-2044.1996.tb14968.x.
Bordet F, Allaouchiche B, Lansiaux S, Combet S, Pouyau A, Taylor P, Bonnard C, Chassard D. Risk factors for airway complications during general anaesthesia in paediatric patients. Paediatr Anaesth. 2002 Nov;12(9):762-9. doi: 10.1046/j.1460-9592.2002.00987.x.
Lalwani K, Richins S, Aliason I, Milczuk H, Fu R. The laryngeal mask airway for pediatric adenotonsillectomy: predictors of failure and complications. Int J Pediatr Otorhinolaryngol. 2013 Jan;77(1):25-8. doi: 10.1016/j.ijporl.2012.09.021. Epub 2012 Oct 11.
Mathis MR, Haydar B, Taylor EL, Morris M, Malviya SV, Christensen RE, Ramachandran SK, Kheterpal S. Failure of the Laryngeal Mask Airway Unique and Classic in the pediatric surgical patient: a study of clinical predictors and outcomes. Anesthesiology. 2013 Dec;119(6):1284-95. doi: 10.1097/ALN.0000000000000015.
Other Identifiers
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2014-15832
Identifier Type: -
Identifier Source: org_study_id
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