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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01633073
Recruitment Status : Completed
First Posted : July 4, 2012
Last Update Posted : October 2, 2012
Sponsor:
Information provided by (Responsible Party):
Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago

Tracking Information
First Submitted Date  ICMJE June 28, 2012
First Posted Date  ICMJE July 4, 2012
Last Update Posted Date October 2, 2012
Study Start Date  ICMJE June 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2012)
Airway Leak Pressure [ Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2012)
  • 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    The ease of gastric placement will be timed and assessed using a subjective scale
  • 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 ]
    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 ]
    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 ]
    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 ]
    Assessed by the subject's response or parents subjective assesment 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 ]
    Assessed by the subject's response or parents subjective assesment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of the Laryngeal Mask Airway (LMA) Supreme and I-gel in Children
Official Title  ICMJE A Randomized Trial Comparing the Laryngeal Mask Airway-SupremeTM With the i-gelTM in Children
Brief Summary The aim of this randomized prospective study is to compare two single-use laryngeal mask airways with a provision of a gastric drain tube allowing for evacuation of gastric contents, the i-gel and the LMA Supreme, in pediatric patients undergoing positive pressure ventilation. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme.
Detailed Description The goal of this study is to compare the LMA Supreme and i-gel in children having surgery. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme. 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 during positive pressure ventilation, ease of gastric tube placement, and complications (airway related, gastric insufflation, and trauma) will also be assessed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Condition  ICMJE Laryngeal Masks in Children
Intervention  ICMJE
  • Device: LMA Supreme: control device
    LMA Supreme will be placed in children weighing 5-50kg based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, 2.5, or 3.0. 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
  • Device: i-gel: comparison device
    i-gel will be placed in children weighing 5-50kg based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, 2.5, or 3.0. 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
Study Arms  ICMJE
  • Active Comparator: LMA Supreme
    Intervention: Device: LMA Supreme: control device
  • Active Comparator: i-gel
    Intervention: Device: i-gel: comparison device
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2012)
170
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2012)
200
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children undergoing general anesthesia using a supraglottic airway device
  • weight 5-50 kg
  • age 3 months-11 years

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01633073
Other Study ID Numbers  ICMJE SLMA vs i-gel
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago
Study Sponsor  ICMJE Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Narasimhan Jagannathan, MD Ann & Robert H Lurie Children's Hospital of Chicago
PRS Account Ann & Robert H Lurie Children's Hospital of Chicago
Verification Date October 2012

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