Clinical trial NCT02202174: The Safety and Efficacy of Supraglottic Airway Use in Children
Official title: The Safety and Efficacy of Supraglottic Airway Use in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Supraglottic Airway Use in Children
Keywords: supraglottic airway
children
safety
efficacy
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2014-07-28
Enrollment: 10000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients undergoing anesthesia with use of a supraglottic airway device as primary means of oxygenation and ventilation.

Brief summary: This purpose of this study is to determine the effectiveness, risk factors, and complications associated with use of supraglottic airway devices for primary airway maintenance during routine anesthesia in children.

Detailed description: This study aims to understand the efficacy of supraglottic airway (SGA) use in children in a tertiary care Children's Hospital.

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.

Eligibility criteria: Inclusion Criteria:

* Children undergoing anesthesia with use of a supraglottic airway device as a primary means of oxygenation \& ventilation

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Supraglottic Airway Device Failure
timeFrame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Secondary outcomes:
measure: Ease of Placement of Supraglottic Airway Device
timeFrame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Multiple Attempts to Place Supraglottic Airway Device
timeFrame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Airway Maneuvers/interventions
timeFrame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Occurrence of Inadequate Ventilation
timeFrame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Intraoperative Complications
timeFrame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Postoperative Complications
timeFrame: participants will be followed for the duration of anesthesia and 24 hours postoperatively
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H. Lurie Children's Hospital of Chicago / Stanley Manne Research Institute
name: Narasimhan Jagannathan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.