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Assessment of the I-gel and Air-Q Supraglottic Airways as Conduits for Tracheal Intubation in Children

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ClinicalTrials.gov Identifier: NCT02189590
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):
Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago

Study Description
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Brief Summary:
The purpose of this study is to determine if there is a difference in time for successful fiberoptic guided tracheal intubation through the i-gel or air-Q supraglottic airway.

Condition or disease Intervention/treatment Phase
Tracheal Intubation in Children Device: i-gel Device: air-Q Not Applicable

Detailed Description:
The goal of this randomized study is to evaluate the efficacy of the i-gel as a conduit for fiberoptic tracheal intubation when compared to the air-Q in children. Intubations will be performed by residents in training. The primary outcome is of time for successful tracheal intubation. The investigators hypothesize that residents will intubate the trachea faster when using the air-Q as compared to the i-gel. The ease of placement of the supraglottic airway device, fiberoptic grade of laryngeal view, time for device removal after intubation, and peri-operative complications will also be assessed.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Official Title: A Randomized Comparison of the I-gel and Air-Q as Conduits for Fiberoptic-guided Tracheal Intubation in Children
Study Start Date : July 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: air-Q
Patients will receive the air-Q with size based on manufacturer recommendations of body weight
 Device: air-Q
Patients randomized to this intervention will have the air-Q placed following induction of general anesthesia. Subsequent tracheal intubation will be performed using the device as a conduit for fiberoptic-guided intubation. Following successful tracheal intubation, the device will be removed.
Experimental: i-gel
Patients will receive the i-gel with size based on manufacturer recommendations of body weight
 Device: i-gel
Patients randomized to this intervention will have the i-gel placed following induction of general anesthesia. Subsequent tracheal intubation will be performed using the device as a conduit for fiberoptic-guided intubation. Following successful tracheal intubation, the device will be removed.


Outcome Measures
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Primary Outcome Measures :
  1. Time to Successful Tracheal Intubation [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ]
    Time to successful tracheal intubation when using fiberoptic bronchoscopy to intubate through the i-gel or air-Q ILA. Three separate times will be measured by an independent observer: 1) Time to first glottic view: defined as the duration of time ending with the first view of the glottic opening. 2) Time to carinal view: defined as the duration of time ending with visualization of the carina. 3) Time to successful tracheal intubation: defined as the duration of time ending with the observation of a square wave end-tidal capnogram after successful tracheal intubation


Secondary Outcome Measures :
  1. Ease of Placement of Supraglottic Airway [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ]
    Ease of placement of supraglottic device ranging from 1 (easy) to 4 (difficult).

  2. Number of Attempts to Place the Supraglottic Device [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ]
    Number of attempts will be limited to 3

  3. Supraglottic Airway Leak Pressure [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ]
    The airway pressure at which an airway leak is observed after placement of the supraglottic airway

  4. 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 ]
    Fiberoptic Grade of Laryngeal View through either the air Q or i-gel will be graded using a previously published grading system

  5. Airway Maneuvers [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ]
    The number and type of airway maneuvers performed during tracheal intubation will be recorded

  6. Postoperative Complications [ Time Frame: Participants will be followed for the duration of anesthesia and 24 hours postoperatively ]
    Complications noted postoperatively relating to the airway, such as sore throat or hoarseness.

  7. Time to Placement of Supraglottic Airway [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ]
    Time to placement of supraglottic device will be measured.

  8. Number of Attempts to Place the Tracheal Tube [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ]
    Number of attempts to place the tracheal tube via fiberoptic bronchoscopy through supraglottic device will be limited to 3


Eligibility Criteria
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Ages Eligible for Study:   1 Month to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children undergoing general anesthesia requiring tracheal intubation
  • Age one month to six years

Exclusion Criteria:

  • ASA class IV, V
  • Children receiving emergent surgery
  • History or high suspicion of a difficult airway
  • Active upper respiratory tract infection
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189590


Locations
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United States, Illinois
Anne & 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
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Principal Investigator: Narasimhan Jagannathan, MD Ann & Robert H Lurie Children's Hospital of Chicago / Stanley Manne Research Institute
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Narasimhan Jagannathan, Primary Investigator; MD, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT02189590    
Other Study ID Numbers: I-gel versus air-Q
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014
Keywords provided by Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago:
supraglottic airway
children
fiberoptic guided tracheal intubation
air-Q
i-gel