Back to resultsETI During Spinal Trauma
Primary Purpose
Intubation, Cardiac Arrest
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Standard tracheal tube
ETView VivaSight SL
Sponsored by
About this trial
This is an interventional treatment trial for 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 EducationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ETI during immobilized spine (oral intubation)
ETI during immobilized spine (nasal intubation)
Arm Description
intubation with immobilized cervical spine endotracheal intubation with immobilized cervical spine
intubation with immobilized cervical spine 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
NCT02295631
First Posted
November 18, 2014
Last Updated
November 26, 2014
Sponsor
International Institute of Rescue Research and Education
1. Study Identification
Unique Protocol Identification Number
NCT02295631
Brief Title
ETI During Spinal Trauma
Official Title
A Comparison of Conventional Tube and ETView VivaSight SL Tube for Tracheal Intubation in Patients With a Cervical Spine Immobilisation. A Randomized Cross-over Manikin Trial.
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
December 2014 (Anticipated)
Study Completion Date
December 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 tracheal tubes (standard tube and ETView VivaSight SL) for intubation with an immobilized cervical spine in a standardized manikin model.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation, Cardiac Arrest
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ETI during immobilized spine (oral intubation)
Arm Type
Experimental
Arm Description
intubation with immobilized cervical spine endotracheal intubation with immobilized cervical spine
Arm Title
ETI during immobilized spine (nasal intubation)
Arm Type
Experimental
Arm Description
intubation with immobilized cervical spine endotracheal intubation with immobilized cervical spine
Intervention Type
Device
Intervention Name(s)
Standard tracheal tube
Intervention Description
ETI with standard tracheal tube and Macintosh laryngoscope
Intervention Type
Device
Intervention Name(s)
ETView VivaSight SL
Intervention Description
ETI with ETView VivaSight SL
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrzej Kurowski
Phone
+48500186225
Email
andrzejkurowski987@gmail.com
Facility Information:
Facility Name
International Institute of Rescue Research and Education
City
Warsaw
State/Province
Masovia
ZIP/Postal Code
03-122
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak
Phone
+48500186225
Email
lukasz.szarpak@gmail.com
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak
First Name & Middle Initial & Last Name & Degree
Andrzej Kurowski
First Name & Middle Initial & Last Name & Degree
Lukasz Czyżewski
12. IPD Sharing Statement
Learn more about this trial
ETI During Spinal Trauma
We'll reach out to this number within 24 hrs