Gender and Proper Size of Oropharyngeal Airway: Pilot Study

The purpose of this study is to assess the adequacy of mask ventilation with the different sized-oropharyngeal airway.

Study Overview

• Status: Completed
• Conditions: Adult Patients Undergoing Surgery That Requires General Anesthesia
• Intervention / Treatment: Device: No. 7 oral airway; Device: No. 8 oral airway; Device: No. 9 oral airway

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Korea
    • Seoul, Korea, Korea, Republic of, 120-752
      • Department of Anesthesiology and Pain MedicineSeverance Hospital, Yonsei University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• body mass index over 35 kg/m2
• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: No. 7 oral airway	Device: No. 7 oral airway; the use of 7 cm sized-oropharyngeal airway (Guedel-type color coded oropharyngeal airway, Hudson RCI, Teleflex Medical, Research Triangle Park, NC)
Experimental: No. 8 oral airway	Device: No. 8 oral airway; the use of 8 cm sized-oropharyngeal airway (Guedel-type color coded oropharyngeal airway, Hudson RCI, Teleflex Medical, Research Triangle Park, NC)
Active Comparator: No. 9 oral airway	Device: No. 9 oral airway; the use of 9 cm sized-oropharyngeal airway (Guedel-type color coded oropharyngeal airway, Hudson RCI, Teleflex Medical, Research Triangle Park, NC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the proportion of patients whose oropharyngeal airway is proper	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 face 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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: December 22, 2014
• First Submitted That Met QC Criteria: December 22, 2014
• First Posted (Estimate): December 29, 2014

Study Record Updates

• Last Update Posted (Estimate): July 31, 2015
• Last Update Submitted That Met QC Criteria: July 30, 2015
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 4-2014-0805