Ambu Aura-i and Air-Q Intubating Laryngeal Airways as a Conduit for Tracheal Intubation 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:
NCT01535742
First received: February 13, 2012
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to determine whether there is a clinically relevant difference in time to tracheal intubation when using fiberoptic bronchoscope as a guide to intubate through the Ambu Aura-i or air-Q ILA.


Condition Intervention
Tracheal Intubation in Children
Device: Ambu Aura-i size 1.5
Device: air-Q ILA size 1.5
Device: Ambu Aura-i size 2
Device: air-Q ILA size 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Official Title: Prospective Randomized Comparison of the Ambu Aura-i and Air-Q Intubating Laryngeal Airways as a Conduit for Tracheal Intubation in Children

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

Primary Outcome Measures:
  • Ease and 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 ] [ Designated as safety issue: No ]
    from the time of fiberoptic bronchoscope entry into the device until positive clinical signs indicating successful tracheal intubation (i.e., presence of bilateral breath sounds, appropriate end-tidal CO2) are confirmed


Secondary Outcome Measures:
  • Ease and time to place 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 supraglottic device and tracheal 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 ]
    number of attempts needed for successful placement will be recorded (maximum of 3 attempts; >3 attempts will be considered as a failure)

  • 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

  • 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

  • Time to remove 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 ]
    removal will be done with the use of a removal stylet. Should inadvertent extubation occur during removal of the device, the intubation will be deemed a failure.

  • Airway maneuvers [ 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 number and type of various airway maneuvers such as jaw thrust, neck extension, advancement/ withdrawal of the supraglottic device, and/ or anterior Laryngeal Pressure to optimize tracheal intubation will be recorded

  • 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, inadvertent extubation, tracheal pilot balloon breakage, mucosal trauma, reflex activation of the airway, sore throat, dysphonia will be recorded


Enrollment: 120
Study Start Date: February 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ambu Aura-i size 1.5
patients will receive either the Ambu Aura-i size 1.5 or air-Q ILA 1.5 based on manufacturer recommendations of body weight
Device: Ambu Aura-i size 1.5
Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed
Experimental: air-Q size 1.5
patients will receive either the Ambu Aura-i size 1.5 or air-Q ILA 1.5 based on manufacturer recommendations of body weight
Device: air-Q ILA size 1.5
Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed
Experimental: Ambu Aura-i size 2
patients will receive either the Ambu Aura-i size 2 or air-Q ILA 2 based on manufacturer recommendations of body weight
Device: Ambu Aura-i size 2
Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed
Experimental: air-Q size 2
patients will receive either the Ambu Aura-i size 2 or air-Q ILA 2 based on manufacturer recommendations of body weight
Device: air-Q ILA size 2
Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed

Detailed Description:

The goal of this prospective randomized study is to compare the Ambu Aura-i and air-Q ILA in children with normal airway anatomy, in order to evaluate the effectiveness of fiberoptic tracheal intubation through these two devices. The ease of placement, fiberoptic grade of laryngeal view, time to tracheal intubation, time for device removal after intubation, and peri-operative complications will also be assessed.

  Eligibility

Ages Eligible for Study:   1 Month to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children undergoing general anesthesia requiring tracheal intubation
  • Weight 5-20 kg
  • Age one month-six years

Exclusion Criteria:

  • ASA class IV, V Emergency procedures
  • History of a difficult airway
  • Active upper respiratory tract infection
  • Children receiving emergent surgery
  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: NCT01535742

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 Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

Publications:
Responsible Party: Narasimhan Jagannathan, primary investigator; MD, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT01535742     History of Changes
Other Study ID Numbers: Air-Q versus Ambu-Aura-i
Study First Received: February 13, 2012
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
laryngeal mask airway
children
tracheal intubation
fiberoptic bronchoscopy

ClinicalTrials.gov processed this record on July 22, 2014