Back to resultsEndotracheal Intubation During Resuscitation (EIDR)
Primary Purpose
Cardiac Arrest
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Bonfils
Macintosh
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Arrest focused on measuring Intubation, Endotracheal
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 (paramedics, nurses, physicians)
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
Endotracheal intubation without chest compressions
Endotracheal intubation with uninterrupted chest compressions
Arm Description
Endotracheal intubation of 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.
POGO score
self-reported percentage of glottis opening (POGO) score
Full Information
NCT ID
NCT02286323
First Posted
November 5, 2014
Last Updated
November 7, 2014
Sponsor
International Institute of Rescue Research and Education
1. Study Identification
Unique Protocol Identification Number
NCT02286323
Brief Title
Endotracheal Intubation During Resuscitation
Acronym
EIDR
Official Title
Can the Bonfils Intubation Fiberscope Rival the Macintosh Laryngoscope During Resuscitation With Uninterrupted Chest Compression?
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
We hypothesized that the BONFILS is beneficial for intubation of manikins while performing CPR. In the current study we compared the performance of the BONFILS and the Macintosh laryngoscopes with respect to their effectiveness and time to successful ETI during chest compression (CC) using an adult manikin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Intubation, Endotracheal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endotracheal intubation without chest compressions
Arm Type
Experimental
Arm Description
Endotracheal intubation of mannikin during resuscitation without chest compressions.
Arm Title
Endotracheal intubation with uninterrupted 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)
Bonfils
Intervention Description
Bonfils Intubation Fiberoscope
Intervention Type
Device
Intervention Name(s)
Macintosh
Intervention Description
Direct laryngoscopy using Macintosh Laryngoscope
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
intraoperative
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
intraoperative
Title
POGO score
Description
self-reported percentage of glottis opening (POGO) score
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
minimum 1 year of work experience in emergency medicine
experienced emergency medical personnel (paramedics, nurses, physicians)
Exclusion Criteria:
not meet the above criteria
wrist or low back diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrzej Kurowski
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
04-628
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Endotracheal Intubation During Resuscitation
We'll reach out to this number within 24 hrs