- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01945411
Assessment of Facial Measurements, the Length of Mouth Corner-mandible Angle and Incisors-mandible Angle, for Determining the Proper Sizes of Oropharyngeal Airway
July 30, 2015 updated by: Yonsei University
The purpose of this study is to assess the facial measurements for determining the proper sizes of oropharyngeal airway.
Investigators hypothesized that the length between incisors and mandible angle is more appropriate to estimate the size of oropharyngeal airway compared with the length between mouth corner and mandible angle.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
113
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
-
-
-
Seoul, Korea, Republic of, 120-752
- Severance Hospital
-
-
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
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult patients undergoing surgery that requires general anesthesia
Exclusion Criteria:
- anticipated difficult intubation
- patients without teeth or with loose teeth
- cervical spine disease
- upper airway disease
- body mass index over 35 kg/m2
- pregnancy
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: Experimental
the length between incisor and mandible angle
|
the use of oropharyngeal airway (Guedel-type color coded oropharyngeal airway, Hudson RCI, Teleflex Medical, Research Triangle Park, NC) which size is the length between incisor and mandible angle
|
|
Active Comparator: Active comparator
the length between mouth corner-mandible angle
|
the use of oropharyngeal airway (Guedel-type color coded oropharyngeal airway, Hudson RCI, Teleflex Medical, Research Triangle Park, NC) of which size is the length between mouth corner and mandible angle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
proper size of oropharyngeal airway
Time Frame: up to 10 minutes after the start of anesthetic induction
|
The oropharyngeal airway will be inserted into the patient's mouth.
Investigators will check the laryngeal view using fiberoptic bronchoscope and the adequacy of ventilation after the investigator ventilates the patient using the mask.
If both the laryngeal view and ventilation are appropriate, the size of oropharyngeal airway will be considered as the proper size for the patient.
|
up to 10 minutes after the start of anesthetic induction
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
September 1, 2013
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
September 4, 2013
First Submitted That Met QC Criteria
September 15, 2013
First Posted (Estimate)
September 18, 2013
Study Record Updates
Last Update Posted (Estimate)
July 31, 2015
Last Update Submitted That Met QC Criteria
July 30, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 4-2013-0440
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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