The Influence of Head and Neck Position on the Oropharyngeal Leak Pressure Using Air-Q SP Airway
1 other identifier
interventional
51
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2015
CompletedFirst Posted
Study publicly available on registry
March 30, 2015
CompletedStudy Start
First participant enrolled
May 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 27, 2015
CompletedJanuary 25, 2017
January 1, 2017
4 months
March 24, 2015
January 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Peak airway pressure
Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway
Fiberoptic bronchoscope grade
Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway
Study Arms (4)
Neutral
ACTIVE COMPARATORThe patient's head will be in neutral position.
Flexed
EXPERIMENTALThe patient's head will be flexed.
Extended
EXPERIMENTALThe patient's head will be extended.
Rotated
EXPERIMENTALThe patient's head will be rotated.
Interventions
Eligibility Criteria
You may qualify if:
- adult patients aged over 20 yrs who are scheduled for surgery under general anesthesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, Seoul, 120-752, South Korea
Related Publications (1)
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.
PMID: 28203730DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2015
First Posted
March 30, 2015
Study Start
May 12, 2015
Primary Completion
August 27, 2015
Study Completion
August 27, 2015
Last Updated
January 25, 2017
Record last verified: 2017-01