Clinical trial NCT01449656: A Comparison of the Laryngeal Mask Airway (LMA) Proseal and LMA Supreme in Children
Official title: A Randomized Trial Comparing the Laryngeal Mask Airway-SupremeTM With the Laryngeal Mask Airway-ProsealTM in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2011-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children weighing 10 to 20 kg undergoing surgical or medical procedures under anesthesia requiring a supraglottic airway device

Brief summary: The aim of this randomized prospective study is to compare two laryngeal mask airways with a provision for evacuation of gastric contents, the LMA Proseal and The investigators hypothesize that airway leak pressures with the LMA Proseal will be significantly different (higher) when compared with the LMA Supreme.

Detailed description: The goal of this study is to compare the LMA Proseal and LMA Supreme in children having surgery. The investigators hypothesize that the airway leak pressures with the LMA Proseal will be superior to the LMA Supreme. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement of the device and gastric tube, fiberoptic grade of laryngeal view, feasibility of use during positive pressure ventilation, and complications (airway related, gastric insufflation, trauma) will also be assessed.

Eligibility criteria: Inclusion Criteria:

* Children undergoing general anesthesia using a supraglottic airway device
* weight 10-20 kg
* age 6 months-6 years

Exclusion Criteria:

* ASA class IV, V Emergency procedures
* History of a difficult airway
* Active gastrointestinal reflux
* Active upper respiratory tract infection

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: Fiberoptic view through the gastric tube
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: Adverse effects
timeFrame: Participants will be followed for the duration of anesthesia and 24 hours postoperatively
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Childrens Memorial Hospital
state: Illinois
Study officials:
affiliation: Childrens Memorial Hospital
name: Narasimhan Jagannathan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trevisanuto D, Parotto M, Doglioni N, Ori C, Zanardo V, Micaglio M. The Supreme Laryngeal Mask Airway (LMA): a new neonatal supraglottic device: comparison with Classic and ProSeal LMA in a manikin. Resuscitation. 2012 Jan;83(1):97-100. doi: 10.1016/j.resuscitation.2011.07.032. Epub 2011 Aug 11.
citation: Seet E, Rajeev S, Firoz T, Yousaf F, Wong J, Wong DT, Chung F. Safety and efficacy of laryngeal mask airway Supreme versus laryngeal mask airway ProSeal: a randomized controlled trial. Eur J Anaesthesiol. 2010 Jul;27(7):602-7. doi: 10.1097/eja.0b013e32833679e3.
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.