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Clinical Trials/NCT02532465
NCT02532465CompletedNot Applicable

Glottic View Using Supraglottic Devices in Pediatric Patients

Senthil G. Krishna1 site in 1 country50 target enrollmentStarted: August 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Acceptable View of the Glottic Aperature (Grade I-II)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
— to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • Not provided

Arms & Interventions

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.

Intervention: Air-Q (Device)

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.

Intervention: i-gel (Device)

Outcomes

Primary Outcomes

Acceptable View of the Glottic Aperature (Grade I-II)

Time Frame: 15 seconds after insertion of Air-Q or i-gel

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%.

Secondary Outcomes

  • Airway Insertion Time(Immediately after anesthesia induction)
  • Time to Achieve Best Fiberoptic View(15 seconds after insertion of Air-Q or i-gel)

Investigators

Sponsor
Senthil G. Krishna
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Senthil G. Krishna

Assistant Clinical Professor

Nationwide Children's Hospital

Study Sites (1)

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