Comparing Use of the Glidescope Cobalt to Direct Laryngoscopy in Infants

NCT ID: NCT01163656

Last Updated: 2013-01-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-03-31

Brief Summary

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The investigators seek to prospectively compare intubation with the Glidescope Cobalt to Direct Laryngoscopy (DL) in infants.

Detailed Description

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We seek to study the intubation characteristics of a new video laryngoscope, the Glidescope Cobalt in children less than or equal to 1 yr of age. This evaluation would provide insight as to the efficacy of this device in facilitating intubation in infants.

Conditions

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Intubation

Keywords

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Neonate Laryngoscopes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Direct Laryngoscopy

Laryngoscopy will be performed with the randomized device, which will be the Miller Laryngoscope.

Group Type ACTIVE_COMPARATOR

Miller Laryngoscope

Intervention Type DEVICE

Device is used to facilitate tracheal intubation.

Glidescope Cobalt Video Laryngoscopy

Laryngoscopy will be performed with the randomized device, which will be the Glidescope Cobalt Video Laryngoscope.

Group Type ACTIVE_COMPARATOR

Glidescope Cobalt Video Laryngoscopes

Intervention Type DEVICE

The laryngoscope design with the integration of video technology into the laryngoscope blade.

Interventions

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Miller Laryngoscope

Device is used to facilitate tracheal intubation.

Intervention Type DEVICE

Glidescope Cobalt Video Laryngoscopes

The laryngoscope design with the integration of video technology into the laryngoscope blade.

Intervention Type DEVICE

Other Intervention Names

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tracheal intubation laryngoscopy direct laryngoscopy Glidescope Cobalt Video Laryngoscopy Video Laryngoscopy

Eligibility Criteria

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Inclusion Criteria

1. Scheduled to undergo elective surgery at CHOP
2. American Society of Anesthesiologists (ASA) Physical Status I or II
3. Anesthetic plan requiring tracheal intubation with a neuromuscular relaxant
4. Parental/guardian permission (informed consent). Subjects will be too young to understand the study procedures and therefore assent will not be sought. -

Exclusion Criteria

1. At known or anticipated high risk for aspiration pneumonia
2. Known or predicted difficult intubation as assessed by the clinical attending anesthesiologist
3. Emergency surgical procedure
4. Patients with preoperative airway pathology or stridor -
Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Fiadjoe, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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10-007533

Identifier Type: -

Identifier Source: org_study_id