Glottic View Using Supraglottic Devices in Pediatric Patients

NCT02532465 | Completed Results

• 1 other identifier: IRB15-00486
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Operative Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Airway Insertion Time

  Immediately after anesthesia induction

• Time to Achieve Best Fiberoptic View

  15 seconds after insertion of Air-Q or i-gel

Study Arms (2)

Air-Q

ACTIVE COMPARATOR

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

i-gel

EXPERIMENTAL

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

Interventions

Air-Q DEVICE

Air-Q

i-gel DEVICE

i-gel

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Senthil G. Krishna: lead

Study Sites (1)

Nationwide Children's

Columbus, Ohio, 43205, United States

Location

Results Point of Contact

• Title: Senthil Krishna, MD
• Organization: Nationwide Children's Hospital

Senthil.Krishna@nationwidechildrens.org

614-722-4200

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: August 25, 2015
• Study Start: August 1, 2015
• Primary Completion: July 26, 2018
• Study Completion: September 26, 2018
• Last Updated: August 22, 2019
• Results First Posted: August 22, 2019

Record last verified: 2019-07

Locations

US (1)