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

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ClinicalTrials.gov Identifier: NCT02405390
Recruitment Status : Completed
First Posted : April 1, 2015
Results First Posted : June 12, 2017
Last Update Posted : June 12, 2017
Sponsor:
Collaborator:
Florida International University
Information provided by (Responsible Party):
Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Intubation; Difficult Cervical Spine Injury Procedure: Video Laryngoscopy Procedure: Direct Laryngoscopy Device: Storz C-Mac® laryngoscope Not Applicable

Detailed Description:
Investigator initiated single site prospective and randomized controlled trial.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison of Head Motion in Pediatric Patients Endotracheally Intubated With Video Laryngoscopy (Storz C-Mac®) Versus Direct Laryngoscopy
Study Start Date : February 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015
Arms and Interventions
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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
 Procedure: Direct Laryngoscopy
Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords

Device: Storz C-Mac® laryngoscope


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   up to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02405390


Locations
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United States, Florida
Miami Children's Hospital
Miami, Florida, United States, 33155
Sponsors and Collaborators
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Florida International University
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Nicklaus Children's Hospital f/k/a Miami Children's Hospital
ClinicalTrials.gov Identifier: NCT02405390    
Other Study ID Numbers: 20141780
First Posted: April 1, 2015    Key Record Dates
Results First Posted: June 12, 2017
Last Update Posted: June 12, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nicklaus Children's Hospital f/k/a Miami Children's Hospital:
Storz C-Mac®
Pediatric Airway
Cervical Spine Injury
Trauma Airway Management
Additional relevant MeSH terms:
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Spinal Injuries
Back Injuries
Wounds and Injuries