- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02931019
The Effect of Head Position on the Intubating Condition Using Fiberoptic Bronchoscopy
May 11, 2017 updated by: Sanghee Park, Chonnam National University Hospital
For better view of fiberoptic intubation, the posture of neck is compared between neck flexion and extension.
Study Overview
Study Type
Interventional
Enrollment (Actual)
54
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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Jeollanam-do
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Hwasun, Jeollanam-do, Korea, Republic of, 58128
- Chonnam National University Hwasun Hospital
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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
19 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA class 1 or 2
- scheduled for general anesthesia with endotracheal intubation
- decided to join this clinical study voluntarily
Exclusion Criteria:
- history of difficult intubation
- anticipated the difficult intubation: Total airway score > 6, upper lip bite test grade III, with cervical spine disease, history of head or neck surgery
- risk of aspiration
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: neck flexion first
With specific head posture, intubation is done under flexible fiberoscopy guide. In this arm, at the position with neck flexion, fiberoscopy is pulled into the mouth and get the photo of laryngeal view. After then, neck position is changed to neck extension, And the laryngeal view is gotten in the same way. |
|
|
Experimental: neck extension first
In this arm, at the position with neck extension, fiberoscopy is pulled into the mouth and get the photo of laryngeal view.
After then, neck position is changed to neck flexion, And the laryngeal view is gotten in the same way.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
POGO score
Time Frame: a week (after get the picture)
|
The percentage of glottic opening
|
a week (after get the picture)
|
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 (Actual)
October 13, 2016
Primary Completion (Actual)
January 2, 2017
Study Completion (Actual)
January 2, 2017
Study Registration Dates
First Submitted
October 10, 2016
First Submitted That Met QC Criteria
October 10, 2016
First Posted (Estimate)
October 12, 2016
Study Record Updates
Last Update Posted (Actual)
May 15, 2017
Last Update Submitted That Met QC Criteria
May 11, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CNUHH-2016-120
- Institutional Review Board (Other Identifier: The University of Tennessee Health Science Center)
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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