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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT01653795
First received: July 27, 2012
Last updated: November 17, 2012
Last verified: November 2012
  Purpose

The aim of this randomized prospective study is to compare two single-use laryngeal mask airways the LMA Unique and the LMA Supreme, in pediatric patients. The investigators hypothesize that airway leak pressures with the LMA Supreme will be superior to the LMA Unique.


Condition Intervention
Laryngeal Mask Airway in Children
Device: LMA Unique: control device
Device: LMA Supreme: comparison device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: A Randomized Trial Comparing the Laryngeal Mask Airway-Unique and Laryngeal Mask Airway-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: 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.


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 (only in patients who receive LMA Supreme) [ 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. The LMA Unique does not contain a gastric port so this outcome will only be assessed in patients who received the LMA Supreme device.

  • 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

  • Incidence of device repositioning and/or replacement [ Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours ] [ Designated as safety issue: No ]
    Intra-operative device repositioning or replacement of the device due to excessive air leak or airway obstruction, as evidenced by an obstructive pattern on the continuous end-tidal carbon dioxide monitor that leads to a decrease in oxygen saturation by pulse oximetry to less than 90%.

  • Oropharyngolaryngeal morbidity at discharge [ Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours ] [ Designated as safety issue: Yes ]
    Assessed by the subject's response or parents subjective assessment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort.

  • Oropharyngolaryngeal morbidity at 24 hours post-operatively [ Time Frame: Measured at 24 hours after device placement/study initiation ] [ Designated as safety issue: Yes ]
    Assessed by the subject's response or parents subjective assessment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort.


Enrollment: 180
Study Start Date: July 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LMA Unique Device: LMA Unique: control device
LMA Unique will be placed in children based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, or 2.5. The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.
Other Name: Laryngeal Mask Airway
Active Comparator: LMA Supreme Device: LMA Supreme: comparison device
LMA Supreme will be placed in children based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, or 2.5, The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.
Other Name: Laryngeal Mask Airway

Detailed Description:

The goal of this study is to compare the LMA Unique and LMA-Supreme in children undergoing anesthesia. The investigators hypothesize that airway leak pressures with the LMA Supreme will be superior when compared with the LMA Unique at two different standardized intracuff pressures (40 and 60 cm H20). 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 will also be assessed.

  Eligibility

Ages Eligible for Study:   3 Months to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children undergoing general anesthesia using a supraglottic airway device

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)
  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: NCT01653795

Locations
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: Narasimhan Jagannathan, MD Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

Publications:

Responsible Party: Narasimhan Jagannathan, Principal Investigator, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT01653795     History of Changes
Other Study ID Numbers: LMA-U vs SLMA (multiple sizes)
Study First Received: July 27, 2012
Last Updated: November 17, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 28, 2014