CompletedNCT02402387Updated Jan 25, 2017

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

An interventional study of Neutral head position and Flexed head position in General Anesthesia, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-01-25.

Sponsored by Yonsei University · Not applicable, Interventional, and Diagnostic

Phase: Not applicable
Study type: Interventional
Enrollment: 51
Allocation: Randomized
Ages: 20 Years and older
Sex: All

Study 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.

Conditions studied

General Anesthesia

In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

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

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single (Outcomes assessor)
Enrollment: 51 participants (actual)

Study arms

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.
Procedure: Flexed head position · Device: Air-Q SP Airway
Experimental
Extended
The patient's head will be extended.
Procedure: Extended head position · Device: Air-Q SP Airway
Experimental
Rotated
The patient's head will be rotated.
Procedure: Rotated head position · Device: Air-Q SP Airway

Interventions

ProcedureNeutral head position
ProcedureFlexed head position
ProcedureExtended head position
ProcedureRotated head position
DeviceAir-Q SP Airway

What researchers measure

Primary outcomes

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
Time frame: Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway

Secondary outcomes

Peak airway pressure
Time frame: 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

Study locations

1 site

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

References and documents

Publications

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. PubMed 28203730 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02402387
Lead sponsor: Yonsei University
Responsible party: Sponsor
First posted: Mar 30, 2015
Start date: May 12, 2015
Primary completion: Aug 27, 2015
Completion: Aug 27, 2015
Last update: Jan 25, 2017

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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