Department of anesthesiology,National Taiwan University Hospital
Taipei, Taiwan
Completed
NCT Number: NCT01960673
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
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.
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Notify MeKey information
Age range
20 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
LMA proseal
DeviceIt 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.
igel LMA
DeviceIt 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.
air Q LMA
DeviceIt 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.
ambu LMA
DeviceIt 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.
Primary outcomes
-
the leakage happened between the laryngeal mask and our vocal cord
Time frame: If the ambu bag is flattening during the surgery, the observers check the leak pressure between the laryngeal mask and our vocal cord
The 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 outcomes
-
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.
Time frame: During the surgery
The observer uses the fiberscope to observe the sealing between the vocal cord and epiglottis.
Sponsors and collaborators
Lead sponsor
National Taiwan University Hospital
Other
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Oct 10, 2013
- Registry last updated
- Nov 13, 2015
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.