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Completed

NCT Number: NCT01535742

Ambu Aura-i and Air-Q Intubating Laryngeal Airways as a Conduit for Tracheal Intubation in Children

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.

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Key information

Conditions

Tracheal Intubation in Children

Age range

1 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Childrens Memorial Hospital

Chicago, Illinois, 60614, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ambu Aura-i size 1.5

Device

Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed

air-Q ILA size 1.5

Device

Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed

Ambu Aura-i size 2

Device

Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed

air-Q ILA size 2

Device

Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed

Primary outcomes

  1. 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

    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 outcomes

  1. 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

    From picking up the airway device to bilateral chest expansion and presence of ETCO2

  2. 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

    number of attempts needed for successful placement will be recorded (maximum of 3 attempts; >3 attempts will be considered as a failure)

  3. 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 completely

  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

    The laryngeal alignment through the devices will be graded using an established scoring system

  5. Time to remove device

    Time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

    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.

  6. 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 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

  7. Adverse effects

    Time frame: Participants will be followed for the duration of anesthesia and 24 hours postoperatively

    complications such as oxygen desaturations, inadvertent extubation, tracheal pilot balloon breakage, mucosal trauma, reflex activation of the airway, sore throat, dysphonia will be recorded

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

Prospective Randomized Comparison of the Ambu Aura-i and Air-Q Intubating Laryngeal Airways as a Conduit for Tracheal Intubation in Children

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 20, 2012
Registry last updated
Jun 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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