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

NCT ID: NCT02402387

Last Updated: 2017-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-12

Study Completion Date

2015-08-27

Brief Summary

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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.

Detailed Description

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Conditions

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General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Neutral

The patient's head will be in neutral position.

Group Type ACTIVE_COMPARATOR

Neutral head position

Intervention Type PROCEDURE

Air-Q SP Airway

Intervention Type DEVICE

Flexed

The patient's head will be flexed.

Group Type EXPERIMENTAL

Flexed head position

Intervention Type PROCEDURE

Air-Q SP Airway

Intervention Type DEVICE

Extended

The patient's head will be extended.

Group Type EXPERIMENTAL

Extended head position

Intervention Type PROCEDURE

Air-Q SP Airway

Intervention Type DEVICE

Rotated

The patient's head will be rotated.

Group Type EXPERIMENTAL

Rotated head position

Intervention Type PROCEDURE

Air-Q SP Airway

Intervention Type DEVICE

Interventions

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Neutral head position

Intervention Type PROCEDURE

Flexed head position

Intervention Type PROCEDURE

Extended head position

Intervention Type PROCEDURE

Rotated head position

Intervention Type PROCEDURE

Air-Q SP Airway

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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Kim HJ, Lee K, Bai S, Kim MH, Oh E, Yoo YC. Influence of head and neck position on ventilation using the air-Q(R) SP airway in anaesthetized paralysed patients: a prospective randomized crossover study. Br J Anaesth. 2017 Mar 1;118(3):452-457. doi: 10.1093/bja/aew448.

Reference Type DERIVED
PMID: 28203730 (View on PubMed)

Other Identifiers

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4-2015-0050

Identifier Type: -

Identifier Source: org_study_id

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