- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02295618
ETI During Intubation (SL)
November 27, 2014 updated by: Lukasz Szarpak, International Institute of Rescue Research and Education
Can the ETView VivaSight SL Rival the Macintosh Laryngoscopy With Conventional Tube During Adult Resuscitation by Novice Physicians: a Randomized Crossover Simulation Study.
The objective of this study is to compared effectiveness of intubation using ETView VivaSight SL and standard tracheal tube during resuscitation performed by a novice-physicians.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
107
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
-
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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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- give voluntary consent to participate in the study
- maximum 1 year of work experience in medicine
- maximum 10 clinical intubations
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: ETI with chest compressions
endotracheal intubation (ETI) during child mannikin 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.).
|
Intubation using Macintosh laryngoscope and standard tracheal tube
Intubation using ETView VivaSight SL
|
Experimental: ETI without chest compressions
Endotracheal intubation of child mannikin during resuscitation without chest compressions.
|
Intubation using Macintosh laryngoscope and standard tracheal tube
Intubation using ETView VivaSight SL
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to intubation
Time Frame: 1 day
|
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 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success of intubation
Time Frame: 1 day
|
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 day
|
Cormack-Lehan scale
Time Frame: 1 day
|
self reported Cormack-Lehan scale during intubation
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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 (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
November 18, 2014
First Submitted That Met QC Criteria
November 18, 2014
First Posted (Estimate)
November 20, 2014
Study Record Updates
Last Update Posted (Estimate)
December 2, 2014
Last Update Submitted That Met QC Criteria
November 27, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETI/2014/41
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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