- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02286297
Pediatric Endotracheal Intubation During Resuscitation (PETI)
November 6, 2014 updated by: Lukasz Szarpak, International Institute of Rescue Research and Education
Comparison of Intubation Through the McGrath® MAC, GlideScope®, AirTraq® and Miller Laryngoscope by Paramedics During Pediatric Cardiopulmonary Resuscitation: a Randomized Crossover Manikin Trial.
Endotracheal intubation (ETI) is perceived as the optimal method of providing and maintaining a clear and secure airway.
The 2010 European Resuscitation Council (ERC) guidelines emphasized the importance of minimal interruption during cardiopulmonary resuscitation (CPR).
These guidelines also suggest that skilled operators should be able to secure the airway without interrupting chest compression.
The aim of the study was to compare time and success rates of different available video laryngoscopes and the Miller laryngoscope for emergency intubation during simulated pediatric CPR.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
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 Contact
- Name: Lukasz Czyżewski
- Email: rn.czyzewski@gmail.com
Study Locations
-
-
Masovia
-
Warsaw, Masovia, Poland, 04-628
- Recruiting
- International Institute of Rescue Research and Education
-
-
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 to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- give voluntary consent to participate in the study
- 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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Endotracheal intubation without chest compressions
Endotracheal intubation of mannikin during resuscitation without chest compressions.
|
video-laryngoscopy-1
video-laryngoscopy-2
video-laryngoscopy-3
Direct laryngoscopy
|
Experimental: Endotracheal intubation with uninterrupted 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.).
|
video-laryngoscopy-1
video-laryngoscopy-2
video-laryngoscopy-3
Direct laryngoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to intubation
Time Frame: intraoperative
|
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.
|
intraoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success of intubation
Time Frame: intraoperative
|
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.
|
intraoperative
|
Visual Analog scale (VAS) score
Time Frame: 1 day
|
participants were asked which method they would prefer in a real-life resuscitation
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
November 1, 2014
Primary Completion (Anticipated)
November 1, 2014
Study Completion (Anticipated)
November 1, 2014
Study Registration Dates
First Submitted
November 5, 2014
First Submitted That Met QC Criteria
November 6, 2014
First Posted (Estimate)
November 7, 2014
Study Record Updates
Last Update Posted (Estimate)
November 7, 2014
Last Update Submitted That Met QC Criteria
November 6, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ETI/2014/08
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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