Back to resultsETI During Intubation (SL)
Primary Purpose
Intubation, Cardiac Arrest
Status
Completed
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
- maximum 1 year of work experience in medicine
- maximum 10 clinical intubations
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 2
Arm Type
Experimental
Experimental
Arm Label
ETI with chest compressions
ETI without chest compressions
Arm Description
endotracheal intubation (ETI) during child mannikin resuscitation with uninterrupted chest compressions. In order to simulate the difficulties associated with intubation during uninterrupted chest compressions, CPR was performed by using LUCAS-2 (Physio-Control, Redmond, WA, U.S.).
Endotracheal intubation of child mannikin during resuscitation without chest compressions.
Outcomes
Primary Outcome Measures
Time to intubation
time from insertion of the blade to the first manual ventilation of the manikin´s lungs. If time of intubation is over than 60 seconds, attempt was recognized as failure.
Secondary Outcome Measures
Success of intubation
effectiveness of the first, second and third intubation attempts and overall effectiveness of intubation by participants using four intubation devices. If the examinee failed at all attempts, the case was excluded from the time calculations.
Cormack-Lehan scale
self reported Cormack-Lehan scale during intubation
Full Information
NCT ID
NCT02295618
First Posted
November 18, 2014
Last Updated
November 27, 2014
Sponsor
International Institute of Rescue Research and Education
1. Study Identification
Unique Protocol Identification Number
NCT02295618
Brief Title
ETI During Intubation
Acronym
SL
Official Title
Can the ETView VivaSight SL Rival the Macintosh Laryngoscopy With Conventional Tube During Adult Resuscitation by Novice Physicians: a Randomized Crossover Simulation Study.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
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 objective of this study is to compared effectiveness of intubation using ETView VivaSight SL and standard tracheal tube during resuscitation performed by a novice-physicians.
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
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ETI with chest compressions
Arm Type
Experimental
Arm Description
endotracheal intubation (ETI) during child mannikin resuscitation with uninterrupted chest compressions. In order to simulate the difficulties associated with intubation during uninterrupted chest compressions, CPR was performed by using LUCAS-2 (Physio-Control, Redmond, WA, U.S.).
Arm Title
ETI without chest compressions
Arm Type
Experimental
Arm Description
Endotracheal intubation of child mannikin during resuscitation without chest compressions.
Intervention Type
Device
Intervention Name(s)
Standard tracheal tube
Intervention Description
Intubation using Macintosh laryngoscope and standard tracheal tube
Intervention Type
Device
Intervention Name(s)
ETView VivaSight SL
Intervention Description
Intubation using ETView VivaSight SL
Primary Outcome Measure Information:
Title
Time to intubation
Description
time from insertion of the blade to the first manual ventilation of the manikin´s lungs. If time of intubation is over than 60 seconds, attempt was recognized as failure.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Success of intubation
Description
effectiveness of the first, second and third intubation attempts and overall effectiveness of intubation by participants using four intubation devices. If the examinee failed at all attempts, the case was excluded from the time calculations.
Time Frame
1 day
Title
Cormack-Lehan scale
Description
self reported Cormack-Lehan scale during intubation
Time Frame
1 day
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
maximum 1 year of work experience in medicine
maximum 10 clinical intubations
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
Citations:
PubMed Identifier
26020389
Citation
Kurowski A, Szarpak L, Truszewski Z, Czyzewski L. Can the ETView VivaSight SL Rival Conventional Intubation Using the Macintosh Laryngoscope During Adult Resuscitation by Novice Physicians?: A Randomized Crossover Manikin Study. Medicine (Baltimore). 2015 May;94(21):e850. doi: 10.1097/MD.0000000000000850. Erratum In: Medicine (Baltimore). 2015 Jun;94(25):1.
Results Reference
derived
Learn more about this trial
ETI During Intubation
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