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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambu AuraGain | Experimental | Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines |
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| LMA Supreme | Active Comparator | Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambu AuraGain (size 1.5 or size 2.0) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Oropharyngeal (airway) leak pressure - Initial | The airway pressure at which an airway leak is observed after successful placement of the supraglottic airway | Assessed intraoperatively at the time of confirmed device placement |
| Oropharyngeal (airway) leak pressure - 10 Minutes | The airway pressure at which an airway leak is observed 10 minutes after successful placement of the supraglottic airway | Assessed intraoperatively, 10 minutes after the initial confirmed placement of the device |
| Measure | Description | Time Frame |
|---|---|---|
| Time for Successful Placement of the Supraglottic Airway | Time for successful placement of supraglottic device will be recorded | Assessed intraoperatively at the time of confirmed device placement |
| Number of attempts to placement of Supraglottic Airway |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Narasimhan Jagannathan, M.D. | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19572845 | Background | White MC, Cook TM, Stoddart PA. A critique of elective pediatric supraglottic airway devices. Paediatr Anaesth. 2009 Jul;19 Suppl 1:55-65. doi: 10.1111/j.1460-9592.2009.02997.x. | |
| 25585975 | Background | Jagannathan N, Ramsey MA, White MC, Sohn L. An update on newer pediatric supraglottic airways with recommendations for clinical use. Paediatr Anaesth. 2015 Apr;25(4):334-45. doi: 10.1111/pan.12614. Epub 2015 Jan 13. |
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| LMA Supreme (size 1.5 or size 2.0) | Device | 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. |
|
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Number of attempts and insertion techniques will be recorded (maximum of 3 attempts) |
| Assessed intraoperatively at the time of confirmed device placement |
| Fiberoptic Grade of Laryngeal View through Supraglottic Airway | Fiberoptic Grade of Laryngeal View through either device will be graded using a previously published grading system | Assessed intraoperatively at the time of confirmed device placement |
| Gastric Tube Insertion Ease of Placement | The ease of placement, based on a 1-4 scale, will be recorded following placement and confirmation of the gastric tube. | Assessed intraoperatively at the time of confirmed gastric tube placement |
| Gastric Tube Insertion Time | 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. | Assessed intraoperatively at the time of confirmed gastric tube placement |
| Gastric Tube Insertion Attempts | 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. | Assessed intraoperatively at the time of confirmed gastric tube placement |
| Postoperative Complications | Patient will be evaluated for sore throat, cough, dysphonia, stridor, or other airway related complications during the post-operative period. | Participants will be followed for the duration of hospital stay. Outcome measure will be assessed postoperatively in recovery unit. |
| Intraoperative Complications | Complications such as reflex activation of the airway (coughing, breath holding, laryngospasm, bronchospasm), oxygen desaturation will be recorded, if they occur. | Assessed intraoperatively |
| 22420717 | Background | Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Langen KE, Anderson K. A randomised comparison of the LMA SupremeTM and LMAProSealTM in children. Anaesthesia. 2012 Jun;67(6):632-9. doi: 10.1111/j.1365-2044.2012.07088.x. Epub 2012 Mar 15. |
| 23521105 | Background | Jagannathan N, Sohn L, Sommers K, Belvis D, Shah RD, Sawardekar A, Eidem J, Dagraca J, Mukherji I. A randomized comparison of the laryngeal mask airway supreme and laryngeal mask airway unique in infants and children: does cuff pressure influence leak pressure? Paediatr Anaesth. 2013 Oct;23(10):927-33. doi: 10.1111/pan.12145. Epub 2013 Mar 23. |