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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supraglottic Airway Device | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Supraglottic Airway Device Failure | Occurrence and reason for supraglottic airway device failure (ie inadequate ventilation, laryngospasm, bronchospasm, etc) will be recorded in addition to conversion to tracheal intubation | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Placement of Supraglottic Airway Device | Ease of placement of supraglottic airway device ranging from 1 (easy) to 4 (difficult) | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours |
| Multiple Attempts to Place Supraglottic Airway Device |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients undergoing anesthesia with use of a supraglottic airway device as primary means of oxygenation and ventilation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Narasimhan Jagannathan, MD | Contact | 3122275170 | njagannathan@luriechildrens.org |
| Name | Affiliation | Role |
|---|---|---|
| Narasimhan Jagannathan, MD | Ann & Robert H. Lurie Children's Hospital of Chicago / Stanley Manne Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago | Recruiting | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24322570 | Background | 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. | |
| 24561643 | Background | 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. |
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change in device, placement method, and provider will be recorded |
| participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours |
| Airway Maneuvers/interventions | the number and type of airway maneuvers performed after device placement and during maintenance will be recorded | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours |
| Occurrence of Inadequate Ventilation | cause and solution for inadequate ventilation will be recorded | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours |
| Intraoperative Complications | Time period of complication (ie during device placement, maintenance, or removal) and cause of complication (ie. dental injury, light anesthesia, regurgitation, laryngospasm, bronchospasm, aspiration, etc.) will be recorded | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours |
| Postoperative Complications | Complications noted postoperatively relating to reflex activation of the airway, sore throat, or hoarseness | participants will be followed for the duration of anesthesia and 24 hours postoperatively |
| 8984875 | Background | 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. |
| 12519134 | Background | 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. |
| 23063385 | Background | 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. |
| 24126262 | Background | 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. |