- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02405390
Head Motion in Pediatric Patients Endotracheally Intubated With Video Laryngoscopy Versus Direct Laryngoscopy
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33155
- Miami Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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'
|
Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system
|
Active Comparator: Direct Laryngoscopy
Some patients will be intubated with a direct (conventional) laryngoscope
|
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
Collaborators
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
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20141780
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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