- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02292693
Direct Laryngoscopy During Cervical Trauma
November 14, 2014 updated by: Lukasz Szarpak, International Institute of Rescue Research and Education
Comparison Three Different Laryngoscope Blades for Endotracheal Intubation in Pediatric Patients With Cervical Spine Immobilization.
The aim of this study was to compare time, success rates of different laryngoscope blades for intubation with an immobilized cervical spine in a standardized pediatric manikin model.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
80
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
- 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
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 medicine personnel (physicians, nurses, paramedics)
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: intubation with immobilized cervical spine
endotracheal intubation with immobilized cervical spine
|
Direct laryngoscopy.
Laryngoscopy with Miller blade
Direct laryngoscopy.
Laryngoscopy with Macintosh blade
Direct laryngoscopy.
Laryngoscopy with McCoy blade
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success of intubation
Time Frame: 1 day
|
effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intubation time
Time Frame: 1 day
|
time in seconds required for a successful intubation attempt
|
1 day
|
Cormack-Lehane grading
Time Frame: 1 day
|
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)
|
1 day
|
Preferred ETI device
Time Frame: 1day
|
participants were asked which method of ETI they would prefer in a real-life resuscitation.
|
1day
|
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 12, 2014
First Submitted That Met QC Criteria
November 14, 2014
First Posted (Estimate)
November 17, 2014
Study Record Updates
Last Update Posted (Estimate)
November 17, 2014
Last Update Submitted That Met QC Criteria
November 14, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETI/2014/18
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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