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

January 23, 2017 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Neutral
The patient's head will be in neutral position.
Procedure: Neutral head position
Device: Air-Q SP Airway
Experimental: Flexed
The patient's head will be flexed.
Device: Air-Q SP Airway
Procedure: Flexed head position
Experimental: Extended
The patient's head will be extended.
Device: Air-Q SP Airway
Procedure: Extended head position
Experimental: Rotated
The patient's head will be rotated.
Device: Air-Q SP Airway
Procedure: Rotated head position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oropharyngeal leak pressure
Time Frame: Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway
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 Outcome Measures

Outcome Measure
Time Frame
Peak airway pressure
Time Frame: Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway
Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway
Fiberoptic bronchoscope grade
Time Frame: Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway
Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2015

Primary Completion (Actual)

August 27, 2015

Study Completion (Actual)

August 27, 2015

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

March 27, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 4-2015-0050

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on General Anesthesia

Clinical Trials on Neutral head position

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe