the Influence of Oropharyngeal Leak Pressure and Sealing Between the Mask and Vocal Cord During Changing Patient's Head and Neck PositionPhase 1/2NCT01960673
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
A Phase 1/2 study testing LMA proseal, igel LMA and air Q LMA in people with the Influence of Oropharyngeal Leak Pressure and Sealing Between the Mask and Vocal Cord During Changing Patient's Head and Neck Position, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- the Influence of Oropharyngeal Leak Pressure and Sealing Between the Mask and Vocal Cord During Changing Patient's Head and Neck Position
- What is being tested?
- LMA proseal, igel LMA and air Q LMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2013to Dec 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20-80 yrs old and ASA physical status I or II,
- Receiving minor surgery, ex: breast surgery or cystoscope
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of anesthesiology,National Taiwan University Hospital
Taipei
About this study
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.
Read the 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.
- Being tested
- LMA proseal, igel LMA, air Q LMA, ambu LMA
- Keywords
- supraglottic airway,igel-LMA, ambu-LMA, changing position, head and neck position, oropharyngeal leak pressure,degree of rotation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA prosealDevice
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.
igel LMADevice
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.
air Q LMADevice
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 LMADevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: ambu LMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
The observer uses the fiberscope to observe the sealing between the vocal cord and epiglottis.
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Influence of Oropharyngeal Leak Pressure and Sealing Between the Mask and Vocal Cord During Changing Patient's Head and Neck PositionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cihmin Liu, Principal investigator, anesthesiology department,National Taiwan University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960673
- Sponsor's protocol ID
- 201306042RIND
- Status last verified
- Nov 2015
- First submitted
- 24 Sep 2013
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01960673
- Acronym / sponsor ID
- 201306042RIND
- Keywords
- supraglottic airway,igel-LMA, ambu-LMA, changing position, head and neck position, oropharyngeal leak pressure,degree of rotation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LMA proseal | Experimental | Device: LMA prosealThe 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. |
| igel LMA | Experimental | Device: igel LMAigel 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. |
| air Q LMA | Experimental | Device: air Q LMAThe 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. |
| ambu LMA | Experimental | Device: ambu LMAambu 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 20-80 yrs old and ASA physical status I or II,
- Receiving minor surgery, ex: breast surgery or cystoscope
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMA prosealIt 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. | Device | LMA proseal |
| igel LMAIt 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. | Device | igel LMA |
| air Q LMAIt 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. | Device | air Q LMA |
| ambu LMAIt 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. | Device | ambu LMA |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cihmin Liu principal investigator
anesthesiology department,National Taiwan University hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LMA proseal, igel LMA and air Q LMA in people with the Influence of Oropharyngeal Leak Pressure and Sealing Between the Mask and Vocal Cord During Changing Patient's Head and Neck Position, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2015.