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

May 11, 2017 updated by: Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Comparison of Head Motion in Pediatric Patients Endotracheally Intubated With Video Laryngoscopy (Storz C-Mac®) Versus Direct Laryngoscopy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Investigator initiated single site prospective and randomized controlled trial.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33155
        • Miami Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video Laryngoscopy
Some patients will be intubated with a video laryngoscope 'Storz C-Mac® laryngoscope'
Procedure: Video Laryngoscopy
Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system
Device: Storz C-Mac® laryngoscope
Active Comparator: Direct Laryngoscopy
Some patients will be intubated with a direct (conventional) laryngoscope
Device: Storz C-Mac® laryngoscope
Procedure: Direct Laryngoscopy
Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Head Motion - Extension or Flexion
Time Frame: During the process of intubation (less than one minute)
Head motion will only be measured while the patient is being endotracheally intubated. Usually this takes less than one minute. No follow up after that.
During the process of intubation (less than one minute)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time for Intubation
Time Frame: During the process of intubation (less than one minute)
Time from when the laryngoscope blade enters the mouth until the endotracheal tube enters the vocal cords. No follow up after that.
During the process of intubation (less than one minute)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Florida International University

Investigators

  • Principal Investigator: Jose Vargas Loayza, MD, Miami Children's Hospital Pediatric Emergency Medicine Fellow
  • Study Director: Vincenzo Maniaci, MD, Miami Children's Hospital Pediatric Emergency Medicine Attending

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

February 17, 2015

First Submitted That Met QC Criteria

March 27, 2015

First Posted (Estimate)

April 1, 2015

Study Record Updates

Last Update Posted (Actual)

June 12, 2017

Last Update Submitted That Met QC Criteria

May 11, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20141780

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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