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NCT02402387 Clinical Trial

The Influence of Head and Neck Position on the Oropharyngeal Leak Pressure Using Air-Q SP Airway

General Anesthesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02402387
Other study ID # 4-2015-0050
Secondary ID
Status Completed
Phase N/A
First received March 24, 2015
Last updated January 23, 2017
Start date May 12, 2015
Est. completion date August 27, 2015

Study information
Verified date January 2017
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the changes of the oropharyngeal leak pressure of the air-Q self-pressurizing masked laryngeal airway in the different head and neck positions. Moreover, the adequacy of ventilation will be assessed in the different head and neck positions.

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date August 27, 2015
Est. primary completion date August 27, 2015
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- adult patients aged over 20 yrs who are scheduled for surgery under general anesthesia

Exclusion Criteria:

- anticipated difficult intubation

- body mass index more than 30 km/m2

- history of gastroesophageal reflux disease

- history of esophageal operation

- cervical spine disease

- mass in the oral cavity or neck

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Neutral head position

• Flexed head position

• Extended head position

• Rotated head position

Device:
• Air-Q SP Airway

Locations
Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Oropharyngeal leak pressure The oropharyngeal leak pressure was measured by closing the expiratory valve of the circle system at fixed O2 flow 3L/min and 40 cmH2O Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway
Secondary Peak airway pressure Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway
Secondary Fiberoptic bronchoscope grade Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway
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