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The Influence of Head and Neck Position About Oropharyngeal Leak Pressure and Sealing Between the Laryngeal Mask and Vocal Cord Using Different Types of Supraglottic Airway Device

The Influence of Head and Neck Position About Oropharyngeal Leak Pressure and Sealing Between the Laryngeal Mask and Vocal Cord Using Different Types of Supraglottic Airway Device

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01960673
Enrollment
120
Registered
2013-10-10
Start date
2013-09-30
Completion date
2014-12-31
Last updated
2015-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

the Influence of Oropharyngeal Leak Pressure and Sealing Between the Mask and Vocal Cord During Changing Patient's Head and Neck Position

Keywords

supraglottic airway,igel-LMA, ambu-LMA, changing position, head and neck position, oropharyngeal leak pressure,degree of rotation

Brief summary

Generally, the laryngeal mask airway is not considered in the surgery which should be changing position in the perioperative period. The shape of the pharynx changes during the head and neck movement and there is probably also a change in the force transmitted to the cuff along the airway tube. Besides, there is evidence that supraglottic airway device can be displaced with rotation. In this article, the investigators want to discuss about that oropharyngeal leak pressure and sealing between the mask and vocal cord while changing head and neck position in perioperative period using different types of supraglottic airway device.

Detailed description

The investigators select adult patients,who are 20-80yrs old and ASA physical status I or II, receiving minor surgery, ex: breast surgery or cystoscope, participated in this randomized cross-over trial. Patients were excluded if they were in the above condition. The patient is at high risk of aspiration, ex:obesity, pregnancy upper GI bleeding or not enough fasting time. The patient could not open mouth or upper airway obstruction. The patient receive major surgery, ex: heart, brain, lung, liver, kidney surgery. The patient has abnormal heart and lung function. The patient received different types of supraglottic airway device like proseal LMA,ambu LMA, air Q LMA or igel LMA by draw, then the patients will be divided into different groups.In the preoperative period, the investigators documented oropharyngeal leak pressure in these selected positions: neutral position( 0 degree),and rotation 15, 30,45, 60 degrees, etc. However, oropharyngeal leak pressure was measured by closing the expiratory valve of the circle system at fixed O2 flow 3L/min and 20 cm H2O. If the ambu bag is flattening, the investigators will think the leakage happened between the laryngeal mask and our vocal cord. Then the investigators use fiberscope to observe the condition between the epiglottis and the laryngeal mask. The investigators wanted to compared the mean leak pressure at different head and neck rotation position,ex:neutral,30,45,60 degrees,by using many different types of supraglottic airway device. The observers define the relationship between epiglottis and vocal cord to describe the condition when the patient is at different degree of head and neck position. Grade I is vocal cord completely visible. Grade IIA is only partially vocal cord visible and epiglottis noted. Grade IIB is no vocal cord visible and only epiglottis noted. Grade III is other condition, ex:trapped epiglottis or no epiglottis visible.

Interventions

It would be used to observe the leak pressure at 30,45,60 degree of the head and neck position and the condition between the vocal cord and peri-laryngeal region. The cuff pressure would be kept at 30 cm H20.

DEVICEigel LMA

It would be used to observe the leak pressure at 30,45,60 degree of the head and neck position and the condition between the vocal cord and peri-laryngeal region.

DEVICEair Q LMA

It would be used to observe the leak pressure at 30,45,60 degree of the head and neck position and the condition between the vocal cord and peri-laryngeal region. The cuff pressure would be kept at 30 cm H20.

DEVICEambu LMA

It would be used to observe the leak pressure at 30,45,60 degree of the head and neck position and the condition between the vocal cord and peri-laryngeal region. The cuff pressure would be kept at 30 cm H20.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 20-80 yrs old and ASA physical status I or II, * Receiving minor surgery, ex: breast surgery or cystoscope

Exclusion criteria

* The patient is at high risk of aspiration, ex:obesity, pregnancy upper GI bleeding or not enough fasting time. * The patient could not open mouth or upper airway obstruction * The patient receive major surgery, ex: heart, brain, lung, liver, kidney surgery. * The patient has abnormal heart and lung function.

Design outcomes

Primary

MeasureTime frameDescription
the leakage happened between the laryngeal mask and our vocal cordIf the ambu bag is flattening during the surgery, the observers check the leak pressure between the laryngeal mask and our vocal cordThe oropharyngeal leak pressure was measured by closing the expiratory valve of the circle system at fixed O2 flow 3L/min and 20 cm H2O. If the ambu bag is flattening, the observers will think the leakage happened between the laryngeal mask and the vocal cord

Secondary

MeasureTime frameDescription
Use fiberscope to observe the sealing between the mask and vocal cord while changing head and neck position in perioperative period using different types of supraglottic airway device.During the surgeryThe observer uses the fiberscope to observe the sealing between the vocal cord and epiglottis.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026