NCT01679262

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2012

Completed
Last Updated

September 5, 2012

Status Verified

August 1, 2012

Enrollment Period

2 years

First QC Date

August 31, 2012

Last Update Submit

August 31, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Optimal size of OPA

    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 When the size of OPAs was longer than distance from the incisors to the tip of the epiglottis, OPAs were partly withdrawn and repositioned the distal end of OPAs is placed just above the tip of epiglottis.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.

    1 min after each FOB measurement

Study Arms (1)

Optimal size of OPAs

OTHER
Device: Guedel type color-coded OPAs

Interventions

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. .

Optimal size of OPAs

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \. an abnormal airway anatomy in preoperative radiologic study.
  • \. cervical spine pathology,
  • \. a history of difficult intubation,
  • \. neurologic disease or cardiovascular disease,
  • \. obesity (body mass index ≥ 30 kg m-1),
  • \. dental problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wyun Kon Park, Yonsei University College of Medicine, Department of Anesthesiology and Pain Medicine

Seoul, Seoul, 120-752, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2012

First Posted

September 5, 2012

Study Start

May 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

September 5, 2012

Record last verified: 2012-08

Locations