- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03366311
TCHCCT-Zhong-Xing-Emergency-Department-airway (TT)
December 8, 2017 updated by: Hung,Tzu-Yao, Taipei City Hospital
TCH-Zhong-Xing-Branch-Emergency-Department
To investigate which shapes of stylet, hand techniques and possible condition that improve intubation successful rate and reduce the elapsed intubation time.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
Challenging airway is always a big issue in emergency room.
However, better hand technique, stylet shapes and conditions affecting intubation successful rate, elapsed duration need further investigations.
We compare two endotracheal tube holding position, two holding places, with or without epiglottis lift technique in this study.
All intubation processes in the study will be recorded.
Study Type
Interventional
Enrollment (Anticipated)
45
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
-
-
-
Taipei, Taiwan, 100
- Recruiting
- Taipei City Hospital Zhong-Xing branch
-
Contact:
- Tzu-Yao Hung, MD
- Phone Number: 886-2-979305599
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- care givers with sufficient understanding of airway anatomy and management
Exclusion Criteria:
- N/A
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 |
|---|---|
|
Active Comparator: holding position
different holding position of endotracheal tube
|
two types of holding positions plus two types of shapes of stylet, with or without epiglottis lift
Other Names:
|
|
Active Comparator: stylet shapes
banana shape versus straight-to-cuff shape
|
two types of holding positions plus two types of shapes of stylet, with or without epiglottis lift
Other Names:
|
|
Active Comparator: epiglottis lift
with epiglottis lift or without
|
two types of holding positions plus two types of shapes of stylet, with or without epiglottis lift
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
intubation successful rate
Time Frame: through study completion, and average of 15minutes
|
intubation more than 90 seconds considered as a failed intubation
|
through study completion, and average of 15minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
intubation elapsed time
Time Frame: through study completion, and average of 15minutes
|
from insertion of endotracheal to the tube until proper placement of endotracheal tube
|
through study completion, and average of 15minutes
|
|
insertion elapsed time
Time Frame: through study completion, and average of 15minutes
|
from proper glottic view to the tube until proper placement of endotracheal tube
|
through study completion, and average of 15minutes
|
|
difficulty of intubation
Time Frame: through study completion, and average of 15minutes
|
Visual Analogue Scale with a 10cm bar
|
through study completion, and average of 15minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Tzu-Yao Hung, MD, Taipei City Hospital ZhongXing Branch
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 (Actual)
November 27, 2017
Primary Completion (Anticipated)
November 30, 2018
Study Completion (Anticipated)
November 30, 2019
Study Registration Dates
First Submitted
November 27, 2017
First Submitted That Met QC Criteria
December 7, 2017
First Posted (Actual)
December 8, 2017
Study Record Updates
Last Update Posted (Actual)
December 11, 2017
Last Update Submitted That Met QC Criteria
December 8, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCHCCT-ZXER
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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