- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02804451
Intubation During Cardiopulmonary Resuscitation
June 14, 2016 updated by: Łukasz Szarpak, Medical University of Warsaw
The aim of the study was to compare the intubation time and effectiveness, the grade of larynx visibility, and the ease of intubation in adults performed by nurses using 4 devices: a Macintosh blade laryngoscope (MAC), and a TruView EVO2 (EVO2), TruView EVO2 PCD (PCD), and ETView SL (ETView) laryngoscope, in simulated CPR settings with and without CC.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
47
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, 02-005
- Medical University of Warsaw, Department of Emergency Medicine
-
-
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- had not received any training in endotracheal intubation with videolaryngoscopy before the study,
- had nursing specialization in anaesthesiology or emergency medicine,
- presented with no wrist or low back diseases or pregnancy.
Exclusion Criteria:
- not meet the above criteria.
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intubation without chest compression
normal airway, without chest compression during intubation.
|
intubation with standard macintosh larygoscope; gold standard
Other Names:
A TruView EVO2 laryngoscope with blade size 3 (EVO2; Truphatek Holdings, Ltd., Netanya, Israel),
Other Names:
A TruView EVO2 PCD laryngoscope with blade size 3 (PCD; Truphatek Interbational Ltd., Netanya, Israel),
Other Names:
An ETView SL (ETView; ETViewLtd, Misgav, Israel) ednotracheal tube
Other Names:
|
EXPERIMENTAL: Intubation with uninterrupted chest compression
normal airway, with continuous chest compressions
|
intubation with standard macintosh larygoscope; gold standard
Other Names:
A TruView EVO2 laryngoscope with blade size 3 (EVO2; Truphatek Holdings, Ltd., Netanya, Israel),
Other Names:
A TruView EVO2 PCD laryngoscope with blade size 3 (PCD; Truphatek Interbational Ltd., Netanya, Israel),
Other Names:
An ETView SL (ETView; ETViewLtd, Misgav, Israel) ednotracheal tube
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
time to the first ventilation attempt
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
time to visualize the larynx
Time Frame: 1 day
|
1 day
|
|
time to introduce the endotracheal tube through the vocal cords
Time Frame: 1 day
|
1 day
|
|
success rate
Time Frame: 1 day
|
first intubation attempt success rate
|
1 day
|
degree of larynx visibility
Time Frame: 1 day
|
analysed based on a Cormack-Lehane scale
|
1 day
|
ease of intubation technique
Time Frame: 1 day
|
10-point visual analogue scale (VAS) was used, where 1 indicated an extremely simple procedure, while 10 - an extremely difficult one
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lukasz Szarpak, PhD, Medical University of Warsaw
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
December 1, 2015
Primary Completion (ACTUAL)
March 1, 2016
Study Completion (ACTUAL)
March 1, 2016
Study Registration Dates
First Submitted
June 11, 2016
First Submitted That Met QC Criteria
June 14, 2016
First Posted (ESTIMATE)
June 17, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
June 17, 2016
Last Update Submitted That Met QC Criteria
June 14, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 03/02/2016
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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