Back to resultsDirect Laryngoscopy During Cervical Trauma
Primary Purpose
Trauma
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
MIL
MAC
McCoy
Sponsored by
About this trial
This is an interventional treatment trial for Trauma focused on measuring intubation
Eligibility Criteria
Inclusion Criteria:
- give voluntary consent to participate in the study
- minimum 1 year of work experience in emergency medicine
- experienced emergency medicine personnel (physicians, nurses, paramedics)
Exclusion Criteria:
- not meet the above criteria
- wrist or low back diseases
Sites / Locations
- International Institute of Rescue Research and Education
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intubation with immobilized cervical spine
Arm Description
endotracheal intubation with immobilized cervical spine
Outcomes
Primary Outcome Measures
Success of intubation
effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants
Secondary Outcome Measures
Intubation time
time in seconds required for a successful intubation attempt
Cormack-Lehane grading
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)
Preferred ETI device
participants were asked which method of ETI they would prefer in a real-life resuscitation.
Full Information
NCT ID
NCT02292693
First Posted
November 12, 2014
Last Updated
November 14, 2014
Sponsor
International Institute of Rescue Research and Education
1. Study Identification
Unique Protocol Identification Number
NCT02292693
Brief Title
Direct Laryngoscopy During Cervical Trauma
Official Title
Comparison Three Different Laryngoscope Blades for Endotracheal Intubation in Pediatric Patients With Cervical Spine Immobilization.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Institute of Rescue Research and Education
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study was to compare time, success rates of different laryngoscope blades for intubation with an immobilized cervical spine in a standardized pediatric manikin model.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma
Keywords
intubation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intubation with immobilized cervical spine
Arm Type
Experimental
Arm Description
endotracheal intubation with immobilized cervical spine
Intervention Type
Device
Intervention Name(s)
MIL
Intervention Description
Direct laryngoscopy. Laryngoscopy with Miller blade
Intervention Type
Device
Intervention Name(s)
MAC
Intervention Description
Direct laryngoscopy. Laryngoscopy with Macintosh blade
Intervention Type
Device
Intervention Name(s)
McCoy
Intervention Description
Direct laryngoscopy. Laryngoscopy with McCoy blade
Primary Outcome Measure Information:
Title
Success of intubation
Description
effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Intubation time
Description
time in seconds required for a successful intubation attempt
Time Frame
1 day
Title
Cormack-Lehane grading
Description
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)
Time Frame
1 day
Title
Preferred ETI device
Description
participants were asked which method of ETI they would prefer in a real-life resuscitation.
Time Frame
1day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
give voluntary consent to participate in the study
minimum 1 year of work experience in emergency medicine
experienced emergency medicine personnel (physicians, nurses, paramedics)
Exclusion Criteria:
not meet the above criteria
wrist or low back diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak
Organizational Affiliation
Institute of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Institute of Rescue Research and Education
City
Warsaw
State/Province
Masovia
ZIP/Postal Code
03-122
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Direct Laryngoscopy During Cervical Trauma
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