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

Not Applicable

Completed

• Conditions: Intubation; Difficult; Cervical Spine Injury
• Interventions: Procedure: Direct Laryngoscopy; Procedure: Video Laryngoscopy; Device: Storz C-Mac® laryngoscope

• Registration Number: NCT02405390
• Lead Sponsor: Nicklaus Children's Hospital f/k/a Miami Children's Hospital

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-17
• Study First Submitted QC: 2015-03-27
• Study First Posted: 2015-04-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2017-03
• Results First Submitted: 2017-03-03
• Results First Submitted QC: 2017-05-11
• Last Update Submitted: 2017-05-11
• Results First Posted: 2017-06-12
• Last Update Posted: 2017-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct Laryngoscopy	Direct Laryngoscopy	Some patients will be intubated with a direct (conventional) laryngoscope
Video Laryngoscopy	Video Laryngoscopy	Some patients will be intubated with a video laryngoscope 'Storz C-Mac® laryngoscope'
Video Laryngoscopy	Storz C-Mac® laryngoscope	Some patients will be intubated with a video laryngoscope 'Storz C-Mac® laryngoscope'
Direct Laryngoscopy	Storz C-Mac® laryngoscope	Some patients will be intubated with a direct (conventional) laryngoscope

Primary Outcome Measures

Name	Time	Method
Head Motion - Extension or Flexion	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

Name	Time	Method
Time for Intubation	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.

Trial Locations

Locations (1)

Miami Children's Hospital; 🇺🇸 Miami, Florida, United States