- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02277652
Endotracheal Intubation Devices (ETID)
November 11, 2014 updated by: Lukasz Szarpak, International Institute of Rescue Research and Education
Comparison of Four Different Endotracheal Intubation Devices Performed by Emergency Medical Professionals: a Manikin Study With 6 Airway Scenarios
The purpose of this study was to compare the four different intubation devices in 6 different scenarios.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Masovia
-
Warsaw, Masovia, Poland, 03-122
- Recruiting
- International Institute of Rescue Research and Education
-
Contact:
- Lukasz Szarpak
- Phone Number: (+48)500186225
- Email: lukasz.szarpak@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Scenario 1: Uninterrupted chest compressions
Endotracheal intubation (ETI) during pediatric manikin with uninterrupted chest compressions.
Chest compression was performed using LUCAS-2 (Physio-Control, USA).
|
Direct laryngoscopy
Optical laryngoscopy
Videolaryngoscopy
Blind intubation
|
Experimental: Scenario 2: Neutral position
ETI performed in neutral mannikin head position
|
Direct laryngoscopy
Optical laryngoscopy
Videolaryngoscopy
Blind intubation
|
Experimental: Scenario 3: Sniffing position
ETI performed in sniffing mannikin head position
|
Direct laryngoscopy
Optical laryngoscopy
Videolaryngoscopy
Blind intubation
|
Experimental: Scenario 4: Pharyngeal swelling
ETI performed during mannikin pharyngeal swelling scenario
|
Direct laryngoscopy
Optical laryngoscopy
Videolaryngoscopy
Blind intubation
|
Experimental: Scenario 5: Swollen tongue
ETI performed during mannikin swollen tongue scenario
|
Direct laryngoscopy
Optical laryngoscopy
Videolaryngoscopy
Blind intubation
|
Experimental: Scenario 6: Immobilized cervical spine
ETI performed during mannikin immobilized cervical spine scenario
|
Direct laryngoscopy
Optical laryngoscopy
Videolaryngoscopy
Blind intubation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to intubation
Time Frame: 1 month
|
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.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success of intubation
Time Frame: 1 month
|
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.
|
1 month
|
POGO score
Time Frame: 1 month
|
self-reported percentage of glottis opening (POGO) score
|
1 month
|
VAS score
Time Frame: 1 month
|
participants were asked which method they would prefer in a real-life resuscitation.
|
1 month
|
Cormack-Lehane grading
Time Frame: 1 month
|
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andrzej Kurowski, Institute of Cardiology, Warsaw, Poland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Anticipated)
November 1, 2014
Study Completion (Anticipated)
November 1, 2014
Study Registration Dates
First Submitted
October 26, 2014
First Submitted That Met QC Criteria
October 26, 2014
First Posted (Estimate)
October 29, 2014
Study Record Updates
Last Update Posted (Estimate)
November 13, 2014
Last Update Submitted That Met QC Criteria
November 11, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- ETI/2014/03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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