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NCT02405390 Clinical Trial

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

Intubation; Difficult Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02405390
Other study ID # 20141780
Secondary ID
Status Completed
Phase N/A
First received February 17, 2015
Last updated August 26, 2015
Start date February 2015
Est. completion date June 2015

Study information
Verified date August 2015
Source Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Description:

Investigator initiated single site prospective and randomized controlled trial.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group N/A to 8 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Procedure:
• Video Laryngoscopy
Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system
• Direct Laryngoscopy
Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords
Device:
• Storz C-Mac® laryngoscope

Locations
Country Name City State
United States Miami Children's Hospital Miami Florida

Sponsors (2)
Lead Sponsor Collaborator
Nicklaus Children's Hospital f/k/a Miami Children's Hospital Florida International University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) No
Secondary 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) No
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Completed NCT02566135 - I-gel Versus Classic-Laryngeal Mask Airway (C-LMA) as a Conduit for Tracheal Intubation Using Ventilating Bougie N/A
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