- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02418741
Head Position for Endotracheal Intubation (THHEIEIA)
April 18, 2015 updated by: Mi Ja Yun, MD, PhD, National Medical Center, Seoul
The Degree of Neck Flexion Does Not Influence on the Laryngeal View and Discomfort During Endotracheal Intubation in Adult Patients
The purpose of this study is to investigate whether degree of neck flexion affect on laryngeal view and discomfort during endotracheal intubation in adult patients.
Study Overview
Detailed Description
The neck flexion using a 8 to 10 cm head elevation has been suggested to align laryngeal, pharyngeal and oral axes and facilitate endotracheal intubation by direct laryngoscopy.
There have been scarce clinical studies about the appropriate degree of neck flexion for endotracheal intubation.
In the present study, the laryngeal view and physician's discomfort during endotracheal intubation were evaluated according to the two degrees of neck flexion(4 cm vs 8 cm) using a 4 or 8 cm height of pillows, respectively, in adult patients.
Study Type
Interventional
Enrollment (Actual)
50
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
-
-
Junggu
-
Seoul, Junggu, Korea, Republic of
- National medical center
-
-
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 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Elective operation time ≤2hrs
- American Society of Anesthesiologist, Physical Status 1 or 2
- age ; 18 - 90 years
Exclusion Criteria:
- patient has upper respiratory infection symptoms
- limited mouth opening
- teeth problems
- expecting difficult airway
- congenital heart disease
- patient has a possibility of aspiration pneumonia
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
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Degree of neck flextion
Two degrees of neck flexion were achieved using a 4 cm or 8 cm height of pillow
|
Patient's neck was flexed using a 4 cm or 8 cm height of pillow
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Laryngeal view as index of ease of insertion
Time Frame: one year
|
Cormack Lehane grade during endotracheal intubation
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Discomfort of anesthesiologist during endotracheal intubation
Time Frame: one year
|
Anesthesiologist can feel difficulties in mouth opening and in insertion of laryngoscopic blade into oral cavity according to the degrees of neck flexion
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mija Yun, staff, National medical center
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
August 1, 2013
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
October 12, 2014
First Submitted That Met QC Criteria
April 15, 2015
First Posted (Estimate)
April 16, 2015
Study Record Updates
Last Update Posted (Estimate)
April 21, 2015
Last Update Submitted That Met QC Criteria
April 18, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- H-1312/037-002
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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