A Comparison of the Infant Truview EVO2 Video Laryngoscope and the Macintosh Laryngoscope in Pediatric Patients

NCT ID: NCT00803751

Last Updated: 2017-05-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-12-31

Brief Summary

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This study is intended to examine the effectiveness of a new type of laryngoscope, the Truview EVO2, in an infant patient population. They device will be tested against the current clinical standard, the Macintosh laryngoscope, in patients undergoing surgery at our hospital in terms of ease of use, view obtained of the vocal cords, and ability to place an endotracheal tube.

Detailed Description

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Conditions

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Laryngoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Truview intubation

Receive laryngoscopy with Truview first and is immediately followed by laryngoscopy and intubation with Macintosh

Group Type EXPERIMENTAL

Truview EVO2 laryngoscope

Intervention Type DEVICE

will use the Truview laryngoscope instead of the traditional Macintosh laryngoscope

Macintosh intubation

Macintosh blade will be used first followed by laryngoscopy and intubation with the truview

Group Type ACTIVE_COMPARATOR

Macintosh laryngoscope

Intervention Type DEVICE

Intubation using the traditional Macintosh laryngoscope

Interventions

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Truview EVO2 laryngoscope

will use the Truview laryngoscope instead of the traditional Macintosh laryngoscope

Intervention Type DEVICE

Macintosh laryngoscope

Intubation using the traditional Macintosh laryngoscope

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age less than one year
2. Requiring general anesthesia and orotracheal intubation
3. Weight less than 10 kg
4. ASA class 1-3

Exclusion Criteria

1. Documented difficult airway
2. Facial deformities
Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Maria Matuszczak

Professor - Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Matuszczak, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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Memorial Hermann Hospital - Texas Medical Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.truphatek.com/

Truphatek - Manufacturer's website

Other Identifiers

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Infant Truview

Identifier Type: -

Identifier Source: org_study_id

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