A Comparison of the Laryngeal Mask Airway (LMA) Proseal and LMA Supreme in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Narasimhan Jagannathan, Children's Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01449656
First received: October 4, 2011
Last updated: December 9, 2011
Last verified: December 2011

October 4, 2011
December 9, 2011
October 2011
November 2011   (final data collection date for primary outcome measure)
Airway Leak Pressure [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ] [ Designated as safety issue: No ]
Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached when fresh gas flow is delivered at 3L/min when the pressure limiting valve is closed completely.
Same as current
Complete list of historical versions of study NCT01449656 on ClinicalTrials.gov Archive Site
  • Time to secure the airway [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ] [ Designated as safety issue: No ]
    From picking up the airway device to bilateral chest expansion and presence of ETCO2
  • Number of attempts to place the device [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ] [ Designated as safety issue: No ]
    number of attempts needed for successful placement will be recorded (maximum of 3 attempts will be considered as a failure)
  • Fiberoptic grade of laryngeal view [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ] [ Designated as safety issue: No ]
    The laryngeal alignment through the devices will be graded using an established scoring system
  • Gastric insufflation [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ] [ Designated as safety issue: No ]
    The presence of gastric insufflations will be assessed during leak pressure testing by using epigastric auscultation
  • Ease of gastric tube placement [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ] [ Designated as safety issue: No ]
    The ease of gastric placement will be timed and assessed using a subjective scale
  • Fiberoptic view through the gastric tube [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ] [ Designated as safety issue: No ]
    The view through the gastric drain tube of the LMA supreme will be assessed and graded using an established scoring system
  • feasibility of positive pressure ventilation [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ] [ Designated as safety issue: No ]
    Peak inspiratory pressure and tidal volumes will be recorded. Maximum peak inspiratory pressure will be the airway leak pressure was determined for each patient
  • Quality of the airway [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ] [ Designated as safety issue: No ]
    The quality of hands free anesthesia will be assessed during maintenance of anesthesia using a previously described scale
  • Adverse effects [ Time Frame: Participants will be followed for the duration of anesthesia and 24 hours postoperatively ] [ Designated as safety issue: No ]
    complications such as oxygen desaturations, mucosal trauma, reflex activation of the airway, sore throat, dysphonia will be recorded
Same as current
Not Provided
Not Provided
 
A Comparison of the Laryngeal Mask Airway (LMA) Proseal and LMA Supreme in Children
A Randomized Trial Comparing the Laryngeal Mask Airway-SupremeTM With the Laryngeal Mask Airway-ProsealTM in Children

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Children weighing 10 to 20 kg undergoing surgical or medical procedures under anesthesia requiring a supraglottic airway device

Children
  • Device: LMA Proseal: control device
    LMA Proseal will be placed in children weighing 10-20kg based on a computer generated randomization
    Other Name: laryngeal mask airway
  • Device: LMA Supreme: comparison device
    LMA Supreme will be placed in children weighing 10-20kg based on a computer generated randomization
    Other Name: laryngeal mask airway
  • LMA proseal
    Intervention: Device: LMA Proseal: control device
  • LMA Supreme
    Intervention: Device: LMA Supreme: comparison device

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
6 Months to 6 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01449656
PLMA vs SLMA
No
Narasimhan Jagannathan, Children's Memorial Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
Not Provided
Principal Investigator: Narasimhan Jagannathan, MD Childrens Memorial Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP