Study: Study to Compare Video Miller Device to Direct Laryngoscopy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study is to compare:

the standard pediatric intubation instrument (Miller blade) used as direct laryngoscopy during tracheal intubation to the VideoMiller device (the standard pediatric blade with a camera attached, giving indirect view of the vocal cords in the screen). This intubation device is used to place the tube in the trachea to keep the patient breathing during the surgery procedure.

The anesthesiologist obtains a better view of the vocal cords looking at the screen provided by the VideoMiller.

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Detailed Description

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Conditions

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Surgeries Undergoing General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Video-Miller laryngoscope

using the screen (Video laryngoscopy group)

Group Type ACTIVE_COMPARATOR

VideoMiller

Intervention Type DEVICE

Video-Miller laryngoscope, using the screen (Video laryngoscopy group)

Direct laryngoscopy

without use the screen (Direct laryngoscopy group)

Group Type ACTIVE_COMPARATOR

Direct Laryngoscopy

Intervention Type DEVICE

Video-Miller laryngoscope, without screen (Direct laryngoscopy group)

Interventions

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VideoMiller

Video-Miller laryngoscope, using the screen (Video laryngoscopy group)

Intervention Type DEVICE

Direct Laryngoscopy

Video-Miller laryngoscope, without screen (Direct laryngoscopy group)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients aged 3 years or younger undergoing anesthesia requiring endotracheal intubation.
2. Obtaining signed the informed consent by their parents or legal guardian.
3. American Society of Anaesthesiologists (ASA) physical status classification I - II or III

Exclusion Criteria

1. Patients deemed to be at significant airway risk necessitating an awake fiber optic intubation
2. Patients with facial abnormalities, and/or oral-pharyngeal malformation.
3. Emergency operation

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No