A Comparison of the LMA Unique 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:
NCT01409785
First received: August 3, 2011
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

The goal of this study is to compare the LMA Unique and LMA Supreme in children having surgery. We hypothesize that the airway leak pressures with the LMA Supreme will be superior to the LMA Unique. 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, and complications (airway related, gastric insufflation, trauma) will also be assessed.


Condition
Children

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Prospective, Randomized Comparison of the LMA Unique and LMA Supreme in Children

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

Primary Outcome Measures:
  • Airway leak pressure [ Time Frame: after placement of the supraglottic airway device/ Participants will be followed 24 hours postoperatively ] [ Designated as safety issue: Yes ]
    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:
  • Fiberoptic grade of laryngeal view [ Time Frame: After placement of the supraglottic device ] [ Designated as safety issue: No ]
    The laryngeal alignment through the devices will be graded using an established scoring system

  • Adverse effects [ Time Frame: Participants will be followed 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

  • Time to secure the airway [ Time Frame: after placement of the supraglottic airway device ] [ 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: at the beginning of anesthesia ] [ Designated as safety issue: No ]
    number of attempts needed for successful placement will be recorde (maximum of 3 attempts will be considered as a failure)

  • Fiberoptic view through the gastric tube [ Time Frame: After placement of the LMA supreme ] [ 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

  • Ease of gastric tube placement [ Time Frame: After placement of the LMA supreme ] [ Designated as safety issue: No ]
    The ease of gastric placement will be assessed using a subjective scale

  • Gastric insufflation [ Time Frame: During leak pressure testing ] [ Designated as safety issue: No ]
    The presence of gastric insufflations will be assessed during leak pressure testing by using epigastric auscultation

  • Quality of the airway [ Time Frame: During maintenance of anesthesia ] [ Designated as safety issue: No ]
    The quality of hands free anesthesia will be assessed during maintenance of anesthesia using a previously described scale


Estimated Enrollment: 50
Study Start Date: August 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
LMA Supreme
LMA unique

Detailed Description:

The LMA Supreme is a newer version of the current model, the laryngeal mask airway Unique. Both models are approved for use by the FDA, and are routinely used for airway management during general anesthesia. Three main features distinguish the laryngeal mask airway Supreme from the original LMA: i) a curved rigid airway tube, ii) provision for a gastric drain tube, and iii) a larger mask for improved fit and airway seal.

The aim of this randomized prospective study is to compare two types of the laryngeal mask airway: the laryngeal mask airway Unique and the laryngeal mask airway Supreme, in pediatric patients without the use of neuromuscular blockade. Based on the design features listed above, we hypothesize that the airway leak pressures with the LMA Supreme will be superior to the LMA Unique. 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, 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 25 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 10-25kg
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409785

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
  More Information

Publications:
Responsible Party: Narasimhan Jagannathan, Principal investigator, Children's Memorial Hospital
ClinicalTrials.gov Identifier: NCT01409785     History of Changes
Other Study ID Numbers: LMA unique vs LMA supreme
Study First Received: August 3, 2011
Last Updated: October 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
supraglottic airway devices in children

ClinicalTrials.gov processed this record on April 17, 2014