Head Motion in Pediatric Patients Endotracheally Intubated With Video Laryngoscopy Versus Direct Laryngoscopy

NCT ID: NCT02405390

Last Updated: 2017-06-12

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

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-06-30

Brief Summary

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The purpose of this study is to evaluate if intubation with video laryngoscopy (VL) will result in less head motion and therefore less cervical motion when compared with direct laryngoscopy (DL).

The aim of the study is to determine the amount of head motion (extension, flexion and rotation) when using Storz C-Mac® video laryngoscopes and direct laryngoscopes. Secondarily, the study will also measure the number of attempts to properly intubate and the time required for intubation with either technique.

Detailed Description

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Investigator initiated single site prospective and randomized controlled trial.

Conditions

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Intubation; Difficult Cervical Spine Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Video Laryngoscopy

Some patients will be intubated with a video laryngoscope 'Storz C-Mac® laryngoscope'

Group Type EXPERIMENTAL

Video Laryngoscopy

Intervention Type PROCEDURE

Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system

Storz C-Mac® laryngoscope

Intervention Type DEVICE

Direct Laryngoscopy

Some patients will be intubated with a direct (conventional) laryngoscope

Group Type ACTIVE_COMPARATOR

Direct Laryngoscopy

Intervention Type PROCEDURE

Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords

Storz C-Mac® laryngoscope

Intervention Type DEVICE

Interventions

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Video Laryngoscopy

Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system

Intervention Type PROCEDURE

Direct Laryngoscopy

Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords

Intervention Type PROCEDURE

Storz C-Mac® laryngoscope

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients being orally intubated in the Operating Room as per standard anesthesia procedures

Exclusion Criteria

* previous history of cervical spine injury or surgery
* craniofacial abnormalities
* airway congenital abnormalities
* airway prior to surgery
Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Florida International University

OTHER

Sponsor Role collaborator

Nicklaus Children's Hospital f/k/a Miami Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jose Vargas Loayza, MD

Role: PRINCIPAL_INVESTIGATOR

Miami Children's Hospital Pediatric Emergency Medicine Fellow

Vincenzo Maniaci, MD

Role: STUDY_DIRECTOR

Miami Children's Hospital Pediatric Emergency Medicine Attending

Locations

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Miami Children's Hospital

Miami, Florida, United States

Site Status

Countries

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United States

Related Links

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http://www.mch.com/for-medical-professionals/mch-research-institute.aspx

Miami Children's Hospital Research Institute Website

Other Identifiers

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20141780

Identifier Type: -

Identifier Source: org_study_id

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