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

Not Applicable

Completed

• Conditions: Tracheal Intubation in Children
• Interventions: Device: air-Q; Device: i-gel

• Registration Number: NCT02189590
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

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.

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 Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-09
• Study First Submitted QC: 2014-07-10
• Study First Posted: 2014-07-14
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-22
• Last Update Posted: 2014-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
air-Q	air-Q	Patients will receive the air-Q with size based on manufacturer recommendations of body weight
i-gel	i-gel	Patients will receive the i-gel with size based on manufacturer recommendations of body weight

Primary Outcome Measures

Name	Time	Method
Time to Successful Tracheal Intubation	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

Name	Time	Method
Fiberoptic Grade of Laryngeal View	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
Time to Placement of Supraglottic Airway	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.
Number of Attempts to Place the Supraglottic Device	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
Supraglottic Airway Leak Pressure	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
Postoperative Complications	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.
Number of Attempts to Place the Tracheal Tube	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
Ease of Placement of Supraglottic Airway	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).
Airway Maneuvers	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

Trial Locations

Locations (1)

Anne & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States