The Safety and Efficacy of Supraglottic Airway Use in Children
- Conditions
- Supraglottic Airway Use in Children
- Interventions
- Device: Supraglottic Airway Device
- Registration Number
- NCT02202174
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10000
- Children undergoing anesthesia with use of a supraglottic airway device as a primary means of oxygenation & ventilation
- N/A
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Supraglottic Airway Device 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
- Primary Outcome Measures
Name Time Method Supraglottic Airway Device Failure participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours Occurrence and reason for supraglottic airway device failure (ie inadequate ventilation, laryngospasm, bronchospasm, etc) will be recorded in addition to conversion to tracheal intubation
- Secondary Outcome Measures
Name Time Method Intraoperative Complications participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours 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
Postoperative Complications participants will be followed for the duration of anesthesia and 24 hours postoperatively Complications noted postoperatively relating to reflex activation of the airway, sore throat, or hoarseness
Airway Maneuvers/interventions participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours the number and type of airway maneuvers performed after device placement and during maintenance will be recorded
Occurrence of Inadequate Ventilation participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours cause and solution for inadequate ventilation will be recorded
Multiple Attempts to Place Supraglottic Airway Device participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours change in device, placement method, and provider will be recorded
Ease of Placement of Supraglottic Airway Device participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours Ease of placement of supraglottic airway device ranging from 1 (easy) to 4 (difficult)
Trial Locations
- Locations (1)
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States