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Completed

NCT Number: NCT02405390

Head Motion in Pediatric Patients Endotracheally Intubated With Video Laryngoscopy 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.

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Key information

Conditions

Intubation; Difficult Cervical Spine Injury

Age range

Up to 8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Miami Children's Hospital

Miami, Florida, 33155, United States

About this study

Investigator initiated single site prospective and randomized controlled trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video Laryngoscopy

Procedure

Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system

Direct Laryngoscopy

Procedure

Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords

Storz C-Mac® laryngoscope

Device

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Other

Collaborators

  • Florida International University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 1, 2015
Registry last updated
Jun 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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