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NCT01945411 Clinical Trial

Assessment of Facial Measurements, the Length of Mouth Corner-mandible Angle and Incisors-mandible Angle, for Determining the Proper Sizes of Oropharyngeal Airway

General Anesthesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01945411
Other study ID # 4-2013-0440
Secondary ID
Status Completed
Phase N/A
First received September 4, 2013
Last updated July 30, 2015
Start date September 2013
Est. completion date September 2014

Study information
Verified date July 2015
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 113
Est. completion date September 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• 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
• 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

Locations
Country Name City State
Korea, Republic of Severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary proper size of oropharyngeal airway 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 Yes
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