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

Study Overview
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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.

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

Conditions
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Intubation; Difficult, Cervical Spine Injury

Intervention / Treatment
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* Procedure: Video Laryngoscopy
* Procedure: Direct Laryngoscopy
* Device: Storz C-Mac® laryngoscope


Participation Criteria
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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

Ages Eligible for Study
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Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During the process of intubation (less than one minute) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During the process of intubation (less than one minute) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Storz C-Mac®, Pediatric Airway, Cervical Spine Injury, Trauma Airway Management