Glottic View Using Supraglottic Devices in Pediatric Patients

NCT ID: NCT02532465

Last Updated: 2019-08-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-09-26

Brief Summary

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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.

Detailed Description

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Conditions

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Operative Surgical Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Air-Q

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

i-gel

Intervention Type DEVICE

Interventions

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Air-Q

Intervention Type DEVICE

i-gel

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Senthil G. Krishna

OTHER

Sponsor Role lead

Responsible Party

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Senthil G. Krishna

Assistant Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Nationwide Children's

Columbus, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB15-00486

Identifier Type: -

Identifier Source: org_study_id

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