Glottic View Using Supraglottic Devices in Pediatric Patients

Endotracheal intubation is the gold standard for securing the airway. However, while managing patients with difficult airways, various supraglottic devices have been used as rescue airway devices. The aim of this study is to compare the fiberoptic view through the internal aspect of the i-gel versus the Air-Q LMA in pediatric patients. By examining the fiberoptic view through these two devices, the investigators will determine which device provides a clearer passage to the glottic opening and is therefore the preferred conduit to aid endotracheal intubation in difficult airways.

Study Overview

• Status: Completed
• Conditions: Operative Surgical Procedures
• Intervention / Treatment: Device: Air-Q; Device: i-gel

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients less than 18 years of age who will be receiving an LMA as part of standard of care for their procedure.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Air-Q; The Air-Q is composed of an airway tube that connects to an elliptical mask with a cuff which is inserted through the patient's mouth, down the windpipe, and once deployed forms an airtight seal on top the glottis (unlike tracheal tubes which pass through the glottis) allowing a secure airway to be managed by a health care provider.	Device: Air-Q
Experimental: i-gel; The i-gel is designed to create a non-inflatable anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding the compression trauma that can occur with inflatable supraglottic airway devices.	Device: i-gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptable View of the Glottic Aperature (Grade I-II)	Grade I view - Glottic aperture seen completely without any obstruction, Grade II view - Glottic aperture seen only partially but visual obstruction is less than 50%.	15 seconds after insertion of Air-Q or i-gel

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway Insertion Time	Amount of time it takes to insert airway.	Immediately after anesthesia induction
Time to Achieve Best Fiberoptic View	After confirmation of adequate placement and ventilation, a flexible fiberoptic bronchoscope was inserted through the stem of the supraglottic device to visualize the glottic aperture. The time taken for bronchoscopy, defined as time from disconnection of the anesthetic circuit from the SGA to first visualization of the glottic aperture, was recorded.	15 seconds after insertion of Air-Q or i-gel

Collaborators and Investigators

• Sponsor: Senthil G. Krishna

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): July 26, 2018
• Study Completion (Actual): September 26, 2018

Study Registration Dates

• First Submitted: August 21, 2015
• First Submitted That Met QC Criteria: August 21, 2015
• First Posted (Estimate): August 25, 2015

Study Record Updates

• Last Update Posted (Actual): August 22, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: IRB15-00486