Clinical trial NCT02380768: A Comparison of the Ambu AuraGain Versus LMA Supreme in Children
Official title: A Randomized Comparison of the Ambu AuraGain™ and LMA Supreme™ in Infants and Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supraglottic Airway
Keywords: Supraglottic airway
Laryngeal mask airway
Children
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oropharyngeal (airway) leak pressure - Initial
timeFrame: Assessed intraoperatively at the time of confirmed device placement
measure: Oropharyngeal (airway) leak pressure - 10 Minutes
timeFrame: Assessed intraoperatively, 10 minutes after the initial confirmed placement of the device
Secondary outcomes:
measure: Time for Successful Placement of the Supraglottic Airway
timeFrame: Assessed intraoperatively at the time of confirmed device placement
measure: Number of attempts to placement of Supraglottic Airway
timeFrame: Assessed intraoperatively at the time of confirmed device placement
measure: Fiberoptic Grade of Laryngeal View through Supraglottic Airway
timeFrame: Assessed intraoperatively at the time of confirmed device placement
measure: Gastric Tube Insertion Ease of Placement
timeFrame: Assessed intraoperatively at the time of confirmed gastric tube placement
measure: Gastric Tube Insertion Time
timeFrame: Assessed intraoperatively at the time of confirmed gastric tube placement
measure: Gastric Tube Insertion Attempts
timeFrame: Assessed intraoperatively at the time of confirmed gastric tube placement
measure: Postoperative Complications
timeFrame: Participants will be followed for the duration of hospital stay. Outcome measure will be assessed postoperatively in recovery unit.
measure: Intraoperative Complications
timeFrame: Assessed intraoperatively
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
name: Narasimhan Jagannathan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.