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

October 22, 2014 updated by: Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago

A Randomized Comparison of the I-gel and Air-Q as Conduits for Fiberoptic-guided 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Anne & Robert H. Lurie Children's Hospital of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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
participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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
participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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
participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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
participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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.
Participants will be followed for the duration of anesthesia and 24 hours postoperatively
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.
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
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
participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

  • Principal Investigator: Narasimhan Jagannathan, MD, Ann & Robert H Lurie Children's Hospital of Chicago / Stanley Manne Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

July 9, 2014

First Submitted That Met QC Criteria

July 10, 2014

First Posted (Estimate)

July 14, 2014

Study Record Updates

Last Update Posted (Estimate)

October 24, 2014

Last Update Submitted That Met QC Criteria

October 22, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • I-gel versus air-Q

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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