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
1 other identifier
interventional
92
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 17, 2015
CompletedFirst Posted
Study publicly available on registry
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
June 12, 2017
CompletedJune 12, 2017
March 1, 2017
4 months
February 17, 2015
March 3, 2017
May 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Time for Intubation
During the process of intubation (less than one minute)
Study Arms (2)
Video Laryngoscopy
EXPERIMENTALSome patients will be intubated with a video laryngoscope 'Storz C-Mac® laryngoscope'
Direct Laryngoscopy
ACTIVE COMPARATORSome patients will be intubated with a direct (conventional) laryngoscope
Interventions
Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system
Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords
Eligibility Criteria
You may qualify if:
- patients being orally intubated in the Operating Room as per standard anesthesia procedures
You may not qualify if:
- previous history of cervical spine injury or surgery
- craniofacial abnormalities
- airway congenital abnormalities
- airway prior to surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Miami Children's Hospital
Miami, Florida, 33155, United States
Related Links
Results Point of Contact
- Title
- Jose M. Vargas Loayza, M.D.
- Organization
- Nicklaus Children's Hospital
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2015
First Posted
April 1, 2015
Study Start
February 1, 2015
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
June 12, 2017
Results First Posted
June 12, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share