Clinical trial NCT01633073: A Comparison of the Laryngeal Mask Airway (LMA) Supreme and I-gel in Children
Official title: A Randomized Trial Comparing the Laryngeal Mask Airway-SupremeTM With the i-gelTM in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngeal Masks in Children
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2012-07-04
Enrollment: 170
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this randomized prospective study is to compare two single-use laryngeal mask airways with a provision of a gastric drain tube allowing for evacuation of gastric contents, the i-gel and the LMA Supreme, in pediatric patients undergoing positive pressure ventilation. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme.

Detailed description: The goal of this study is to compare the LMA Supreme and i-gel in children having surgery. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view, feasibility of use during positive pressure ventilation, ease of gastric tube placement, and complications (airway related, gastric insufflation, and trauma) will also be assessed.

Eligibility criteria: Inclusion Criteria:

* Children undergoing general anesthesia using a supraglottic airway device
* weight 5-50 kg
* age 3 months-11 years

Exclusion Criteria:

* ASA class IV, V Emergency procedures
* active respiratory infection
* known history of difficult mask ventilation
* a diagnosis of a congenital syndrome associated with difficult airway management
* airway abnormalities (e.g., laryngomalacia, subglottic stenosis)
* active gastrointestinal reflux
* coagulopathy
* clinically significant pulmonary disease(s)

Primary outcomes:
measure: Airway Leak Pressure
timeFrame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Secondary outcomes:
measure: Time to secure the airway
timeFrame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Number of attempts to place the device
timeFrame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Fiberoptic grade of laryngeal view
timeFrame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Gastric insufflation
timeFrame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Ease of gastric tube placement
timeFrame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Feasibility of positive pressure ventilation
timeFrame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Quality of the airway
timeFrame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
measure: Incidence of device repositioning and/or replacement
timeFrame: Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours
measure: Oropharyngolaryngeal morbidity at discharge
timeFrame: Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours
measure: Oropharyngolaryngeal morbidity at 24 hours post-operatively
timeFrame: Measured at 24 hours after device placement/study initiation
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, MD
role: PRINCIPAL_INVESTIGATOR
References:
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 LE, Chang E, Sawardekar A. A cohort evaluation of the laryngeal mask airway-Supreme in children. Paediatr Anaesth. 2012 Aug;22(8):759-64. doi: 10.1111/j.1460-9592.2012.03832.x. Epub 2012 Mar 15.
citation: Jagannathan N, Sohn LE, Sawardekar A, Chang E, Langen KE, Anderson K. A randomised trial comparing the laryngeal mask airway Supreme with the laryngeal mask airway Unique in children. Anaesthesia. 2012 Feb;67(2):139-44. doi: 10.1111/j.1365-2044.2011.06960.x. Epub 2011 Nov 9.
citation: Lee JR, Kim MS, Kim JT, Byon HJ, Park YH, Kim HS, Kim CS. A randomised trial comparing the i-gel (TM) with the LMA Classic (TM) in children. Anaesthesia. 2012 Jun;67(6):606-11. doi: 10.1111/j.1365-2044.2012.07072.x. Epub 2012 Feb 21.
citation: Goyal R, Shukla RN, Kumar G. Comparison of size 2 i-gel supraglottic airway with LMA-ProSeal and LMA-Classic in spontaneously breathing children undergoing elective surgery. Paediatr Anaesth. 2012 Apr;22(4):355-9. doi: 10.1111/j.1460-9592.2011.03757.x. Epub 2011 Dec 8.
citation: Beringer RM, Kelly F, Cook TM, Nolan J, Hardy R, Simpson T, White MC. A cohort evaluation of the paediatric i-gel() airway during anaesthesia in 120 children. Anaesthesia. 2011 Dec;66(12):1121-6. doi: 10.1111/j.1365-2044.2011.06884.x. Epub 2011 Sep 1.