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

NCT01960673 | Completed Phase 1

• 1 other identifier: 201306042RIND
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• the leakage happened 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

  If the ambu bag is flattening during the surgery, the observers check the leak pressure between the laryngeal mask and our vocal cord

Secondary Outcomes (1)

• 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 surgery

Study Arms (4)

LMA proseal

EXPERIMENTAL

The investigator will use proseal LMA in this study. The cuff of the proseal LMA could be inflation. It is thought to fix the larynx shape. The investigator wants to test the efficacy during 30,45,60 degree of head and neck position.

Device: LMA proseal

igel LMA

EXPERIMENTAL

igel LMA did not have cuff. The shape, softness and contours accurately mirror the perilaryngeal anatomy. The investigator want to test the efficacy of the igel at 30,45,60 degree of head and neck position.

Device: igel LMA

air Q LMA

EXPERIMENTAL

The air-Q LMA should be used routinely as a classic passive airway. It is user-friendly, placement in patients is easy and air movement is outstanding. It has the added benefit of allowing for intubation using standard ET Tubes. It also has the cuff and the contour of the mask is thought to mimic the the shape of the perilaryngeal region. The investigator want to test the efficacy of the air Q LMA at 30,45,60 degree of the head and neck position.

Device: air Q LMA

ambu LMA

EXPERIMENTAL

ambu LMA is also an cuff device LMA. The investigator wanted to test the efficacy about the leak pressure and the view at 30,45,60 degree of head and neck position.

Device: ambu LMA

Interventions

LMA proseal DEVICE

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.

LMA proseal

igel LMA DEVICE

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.

igel LMA

air Q LMA DEVICE

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.

air Q LMA

ambu LMA DEVICE

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.

ambu LMA

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• yrs old and ASA physical status I or II,
• Receiving minor surgery, ex: breast surgery or cystoscope

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of anesthesiology,National Taiwan University Hospital

Taipei, Taiwan

Location

Study Officials

• Cihmin Liu

  anesthesiology department,National Taiwan University hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: October 10, 2013
• Study Start: September 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 13, 2015

Record last verified: 2015-11

Locations

TW (1)