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

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ClinicalTrials.gov Identifier: NCT01679262
Recruitment Status : Completed
First Posted : September 5, 2012
Last Update Posted : September 5, 2012
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Ear,Nose and Throat Surgery Device: Guedel type color-coded OPAs Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : May 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012
Arms and Interventions
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Arm Intervention/treatment
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. .


Outcome Measures
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Primary Outcome Measures :
  1. Optimal size of OPA [ Time Frame: 1 min after each FOB measurement ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679262


Locations
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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
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01679262    
Other Study ID Numbers: 4-2007-0407
First Posted: September 5, 2012    Key Record Dates
Last Update Posted: September 5, 2012
Last Verified: August 2012