NCT01945411

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 18, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

11 months

First QC Date

September 4, 2013

Last Update Submit

July 30, 2015

Conditions

Keywords

Airway ManagementVentilation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Experimental

EXPERIMENTAL

the length between incisor and mandible angle

Device: the length between incisor and mandible angle

Active comparator

ACTIVE COMPARATOR

the length between mouth corner-mandible angle

Device: the length between mouth corner-mandible angle

Interventions

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

Experimental

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

Active comparator

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients undergoing surgery that requires general anesthesia

You may not qualify if:

  • anticipated difficult intubation
  • patients without teeth or with loose teeth
  • cervical spine disease
  • upper airway disease
  • body mass index over 35 kg/m2
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

Related Publications (1)

  • Kim HJ, Kim SH, Min NH, Park WK. Determination of the appropriate sizes of oropharyngeal airways in adults: correlation with external facial measurements: A randomised crossover study. Eur J Anaesthesiol. 2016 Dec;33(12):936-942. doi: 10.1097/EJA.0000000000000439.

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2013

First Posted

September 18, 2013

Study Start

September 1, 2013

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations