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
  Purpose

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.


Condition Intervention
Children
Device: LMA Proseal: control device
Device: LMA Supreme: comparison device

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Randomized Trial Comparing the Laryngeal Mask Airway-SupremeTM With the Laryngeal Mask Airway-ProsealTM in Children

Resource links provided by NLM:


Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 60
Study Start Date: October 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
LMA proseal 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
LMA Supreme 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

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

Ages Eligible for Study:   6 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449656

Locations
United States, Illinois
Childrens Memorial Hospital
Chicago, Illinois, United States, 60614
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: Narasimhan Jagannathan, MD Childrens Memorial Hospital