Pediatric Intubation by Nurses (NURS_ETI)
Primary Purpose
Intubation, Cardiac Arrest
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
AWS
Intubrite
AirTraq
MIL
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 medical personnel - nurses
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
Child ETI withoutchest compressions
Child ETI with chest compressions
Arm Description
Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions.
Endotracheal intubation of mannikin during 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.).
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.
VAS score
participants were asked which method they would prefer in a real-life resuscitation.
Cormack-Lehan scale
self reported Cormack-Lehan scale during intubation
Full Information
NCT ID
NCT02294916
First Posted
November 16, 2014
Last Updated
November 16, 2014
Sponsor
International Institute of Rescue Research and Education
1. Study Identification
Unique Protocol Identification Number
NCT02294916
Brief Title
Pediatric Intubation by Nurses
Acronym
NURS_ETI
Official Title
Comparison of Pentax-AWS Airwayscope, Intubrite, AirTraq and Miller Laryngoscope for Tracheal Intubation by Nurses During Chest Compression in a Pediatric Manikin: A Randomised Crossover 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 purpose of this study was to compare the Pentax AWS, Intubrite and AirTraq to Miller laryngoscope during pediatric resuscitation with and without chest compressions.
Detailed Description
Endotracheal intubation (ETI) is a life-saving procedure performed daily in emergency medicine. The European Resuscitation Council (ERC) 2010 cardiopulmonary resuscitation (CPR) guidelines suggest that intubators should be able to secure the airway without interrupting chest compression. However, ETI with uninterrupted chest compression in patients can be a very difficult skill to acquire.
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
Child ETI withoutchest compressions
Arm Type
Experimental
Arm Description
Endotracheal intubation of pediatric mannikin during resuscitation without chest compressions.
Arm Title
Child ETI with chest compressions
Arm Type
Experimental
Arm Description
Endotracheal intubation of mannikin during 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.).
Intervention Type
Device
Intervention Name(s)
AWS
Other Intervention Name(s)
Pentax AWS
Intervention Description
Video-laryngoscopy 1
Intervention Type
Device
Intervention Name(s)
Intubrite
Other Intervention Name(s)
Intubrite Video Laryngoscope System VLS 6600
Intervention Description
Video-laryngoscopy 2
Intervention Type
Device
Intervention Name(s)
AirTraq
Other Intervention Name(s)
AirTraq Optical Laryngoscope
Intervention Description
Optical-laryngoscopy
Intervention Type
Device
Intervention Name(s)
MIL
Other Intervention Name(s)
Miller Laryngoscope
Intervention Description
Direct-laryngoscopy
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
VAS score
Description
participants were asked which method they would prefer in a real-life resuscitation.
Time Frame
1 day
Title
Cormack-Lehan scale
Description
self reported Cormack-Lehan scale during intubation
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 medical personnel - nurses
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
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
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
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Pediatric Intubation by Nurses
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