Supraglottic Airway
Conditions
Keywords
Supraglottic airway, Laryngeal mask airway, Children
Brief summary
The purpose of this study is to determine whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain and the Laryngeal Mask Airway (LMA) Supreme.
Detailed description
The goal of this prospective randomized study is to compare whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain (sizes 1.5 and 2) and the Laryngeal Mask Airway (LMA) Supreme. Parameters of clinical relevance such as insertion success rates, fiberoptic view of the glottic opening, ease and speed of gastric tube placement, airway stability, and peri-operative complications will also be assessed.
Interventions
DEVICEAmbu AuraGain (size 1.5 or size 2.0)
The device will be inserted and timed. A leak pressure test will be performed after successful insertion and after 10 minutes. The larynx will be visualized by placing a fiberoptic bronchoscope through the device. A gastric tube will be inserted through the device and timed.
DEVICELMA Supreme (size 1.5 or size 2.0)
The device will be inserted and timed. A leak pressure test will be performed after successful insertion and after 10 minutes. The larynx will be visualized by placing a fiberoptic bronchoscope through the device. A gastric tube will be inserted through the device and timed.
Sponsors
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* Scheduled for surgery utilizing a supraglottic airway device * ASA (American Society of Anesthesiologists) I-III classification * Weighing between 5 - 20 kilograms
Exclusion criteria
* Active respiratory infection * History of difficult mask ventilation * Diagnosis of congenital syndrome with difficult airway management * Active gastrointestinal reflux * Coagulopathy * Significant Pulmonary disease * Emergent surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oropharyngeal (airway) leak pressure - Initial | Assessed intraoperatively at the time of confirmed device placement | The airway pressure at which an airway leak is observed after successful placement of the supraglottic airway |
| Oropharyngeal (airway) leak pressure - 10 Minutes | Assessed intraoperatively, 10 minutes after the initial confirmed placement of the device | The airway pressure at which an airway leak is observed 10 minutes after successful placement of the supraglottic airway |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fiberoptic Grade of Laryngeal View through Supraglottic Airway | Assessed intraoperatively at the time of confirmed device placement | Fiberoptic Grade of Laryngeal View through either device will be graded using a previously published grading system |
| Gastric Tube Insertion Ease of Placement | Assessed intraoperatively at the time of confirmed gastric tube placement | The ease of placement, based on a 1-4 scale, will be recorded following placement and confirmation of the gastric tube. |
| Gastric Tube Insertion Time | Assessed intraoperatively at the time of confirmed gastric tube placement | The elapsed time from beginning insertion of the gastric tube to confirmation, will be recorded. Confirmation of gastric tube placement will be determined by injection of air with auscultation (listening for sounds) over the stomach with a stethoscope. |
| Time for Successful Placement of the Supraglottic Airway | Assessed intraoperatively at the time of confirmed device placement | Time for successful placement of supraglottic device will be recorded |
| Postoperative Complications | Participants will be followed for the duration of hospital stay. Outcome measure will be assessed postoperatively in recovery unit. | Patient will be evaluated for sore throat, cough, dysphonia, stridor, or other airway related complications during the post-operative period. |
| Intraoperative Complications | Assessed intraoperatively | Complications such as reflex activation of the airway (coughing, breath holding, laryngospasm, bronchospasm), oxygen desaturation will be recorded, if they occur. |
| Gastric Tube Insertion Attempts | Assessed intraoperatively at the time of confirmed gastric tube placement | Number of insertion attempts of the gastric tube through the SGA will be recorded. Confirmation of gastric tube placement will be determined by injection of air with auscultation (listening for sounds) over the stomach with a stethoscope. |
| Number of attempts to placement of Supraglottic Airway | Assessed intraoperatively at the time of confirmed device placement | Number of attempts and insertion techniques will be recorded (maximum of 3 attempts) |
Countries
United States
Outcome results
None listed