Determination of the Optimal Size of Oropharyngeal Airway; Correlation With External Body Measurements

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01679262
First received: August 31, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

There are several studies that have measured various oropharyngeal airway space distances using radiological method. However, direct confirmation of optimal size of oropharyneal airways (OPAs) in individual using fiberoptic bronchoscope (FOB) is lacking as now. The purposes of this study were to directly determinate the proper size of OPA in individual by FOB via different sizes of OPA in adults under general anestheisia. Additionally, we examine the relationships among the size of OPA, straight length from the incisors to the tip of the epiglottis by laryngoscopy, patient height, and external facial measurements.


Condition Intervention
Ear,Nose and Throat Surgery
Device: Guedel type color-coded OPAs

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Optimal size of OPA [ Time Frame: 1 min after each FOB measurement ] [ Designated as safety issue: No ]
    Primary Outcome - 기술(Description) The distance from the distal end of OPA to the tip of the epiglottis was calculated by the difference between measured distance from the incisors to the tip of the epiglottis via each OPA by FOB and typical distance from the flange to distal end of each OPA via inside tube of OPA. When the size of OPAs was longer than distance from the incisors to the tip of the epiglottis, OPAs were partly withdrawn and repositioned the distal end of OPAs is placed just above the tip of epiglottis. Then, the length from the incisors to the flange of OPAs was measured. The optimal size of OPAs in individuals was defined that the distal end of OPA is placed the tip of epiglottis as close as possible without impingement on the epiglottis when the flange of OPA contact with the four central incisors.


Enrollment: 149
Study Start Date: May 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Optimal size of OPAs Device: Guedel type color-coded OPAs
The OPAs was used four different sizes as No. 8 (80 mm, green), 9 (90 mm, yellow), 10 (100 mm, red), and 11 (110 mm, orange) in regular sequence. The curvilinear distance from the incisors to the tip of the epiglottis was measured by FOB (Olympus LF-GP; Olympus Optical Co., Tokyo, Japan) with tape marking via each size of OPAs. The distance from the distal end of OPA to the tip of the epiglottis was calculated by the difference between measured distance from the incisors to the tip of the epiglottis via each OPA by FOB and typical distance from the flange to distal end of each OPA via inside tube of OPA. When the size of OPAs was longer than distance from the incisors to the tip of the epiglottis, OPAs were partly withdrawn and repositioned the distal end of OPAs is placed just above the tip of epiglottis. Then, the length from the incisors to the flange of OPAs was measured. .

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA class I-II 2. 20-70 years adults

Exclusion Criteria:

  • 1. an abnormal airway anatomy in preoperative radiologic study.
  • 2. cervical spine pathology,
  • 3. a history of difficult intubation,
  • 4. neurologic disease or cardiovascular disease,
  • 5. obesity (body mass index ≥ 30 kg m-1),
  • 6. dental problem
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01679262

Locations
Korea, Republic of
Wyun Kon Park, Yonsei University College of Medicine, Department of Anesthesiology and Pain Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01679262     History of Changes
Other Study ID Numbers: 4-2007-0407
Study First Received: August 31, 2012
Last Updated: August 31, 2012
Health Authority: KFDA: South Korea

ClinicalTrials.gov processed this record on July 20, 2014