Head Motion in Pediatric Patients Endotracheally Intubated With Video Laryngoscopy Versus Direct Laryngoscopy
Primary Purpose
Intubation; Difficult, Cervical Spine Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video Laryngoscopy
Direct Laryngoscopy
Storz C-Mac® laryngoscope
Sponsored by
About this trial
This is an interventional supportive care trial for Intubation; Difficult focused on measuring Storz C-Mac®, Pediatric Airway, Cervical Spine Injury, Trauma Airway Management
Eligibility 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
Sites / Locations
- Miami Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Video Laryngoscopy
Direct Laryngoscopy
Arm Description
Some patients will be intubated with a video laryngoscope 'Storz C-Mac® laryngoscope'
Some patients will be intubated with a direct (conventional) laryngoscope
Outcomes
Primary Outcome Measures
Head Motion - Extension or Flexion
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
Time for Intubation
Time from when the laryngoscope blade enters the mouth until the endotracheal tube enters the vocal cords. No follow up after that.
Full Information
NCT ID
NCT02405390
First Posted
February 17, 2015
Last Updated
May 11, 2017
Sponsor
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Collaborators
Florida International University
1. Study Identification
Unique Protocol Identification Number
NCT02405390
Brief Title
Head Motion in Pediatric Patients Endotracheally Intubated With Video Laryngoscopy Versus Direct Laryngoscopy
Official Title
Comparison of Head Motion in Pediatric Patients Endotracheally Intubated With Video Laryngoscopy (Storz C-Mac®) Versus Direct Laryngoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Collaborators
Florida International University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Investigator initiated single site prospective and randomized controlled trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation; Difficult, Cervical Spine Injury
Keywords
Storz C-Mac®, Pediatric Airway, Cervical Spine Injury, Trauma Airway Management
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Video Laryngoscopy
Arm Type
Experimental
Arm Description
Some patients will be intubated with a video laryngoscope 'Storz C-Mac® laryngoscope'
Arm Title
Direct Laryngoscopy
Arm Type
Active Comparator
Arm Description
Some patients will be intubated with a direct (conventional) laryngoscope
Intervention Type
Procedure
Intervention Name(s)
Video Laryngoscopy
Intervention Description
Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system
Intervention Type
Procedure
Intervention Name(s)
Direct Laryngoscopy
Intervention Description
Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords
Intervention Type
Device
Intervention Name(s)
Storz C-Mac® laryngoscope
Primary Outcome Measure Information:
Title
Head Motion - Extension or Flexion
Description
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.
Time Frame
During the process of intubation (less than one minute)
Secondary Outcome Measure Information:
Title
Time for Intubation
Description
Time from when the laryngoscope blade enters the mouth until the endotracheal tube enters the vocal cords. No follow up after that.
Time Frame
During the process of intubation (less than one minute)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Vargas Loayza, MD
Organizational Affiliation
Miami Children's Hospital Pediatric Emergency Medicine Fellow
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vincenzo Maniaci, MD
Organizational Affiliation
Miami Children's Hospital Pediatric Emergency Medicine Attending
Official's Role
Study Director
Facility Information:
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.mch.com/for-medical-professionals/mch-research-institute.aspx
Description
Miami Children's Hospital Research Institute Website
Learn more about this trial
Head Motion in Pediatric Patients Endotracheally Intubated With Video Laryngoscopy Versus Direct Laryngoscopy
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