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Completed

NCT Number: NCT02189590

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

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.

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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

Anne & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

About this study

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.

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
  • 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

Treatment and study plan

I-gel

Device

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.

air-Q

Device

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

A Randomized Comparison of the I-gel and Air-Q as Conduits for Fiberoptic-guided Tracheal Intubation in Children

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 14, 2014
Registry last updated
Oct 24, 2014

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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