AnesthesiaRCVPENCT02502422
Relationship Between Optimal Laryngeal Mask Airway Cuff Volume and Physical Examination of Head and Neck
A study testing Classic laryngeal mask airway in people with Anesthesia, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
Overinflation of laryngeal mask airway cuff increase side effect like hoarseness, vocal cord paralysis, sorethroat. The investigators will study correlation between laryngeal mask airway cuff volume and pressure and physical examination of head and neck. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Classic laryngeal mask airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2015to Dec 2015
- Phase
- Interventional
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (age 19-65)
- American Society of Anesthesiology Classification I-III
Who cannot join
- cardiovascular disease, cerebrovascular disease, pulmonary disease
- patient who have operation history for airway
- patient who expected difficult intubation
- patient who have risk of aspiration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Optimal Laryngeal Mask Airway Cuff Volume From Parameters of Physical Examination of Head and Neck
Overinflation of laryngeal mask airway cuff increase side effect like hoarseness, vocal cord paralysis, sorethroat. The investigators will study correlation between laryngeal mask airway cuff volume and pressure and physical examination of head and neck.
Read the detailed description
Overinflation of laryngeal mask airway cuff can induce side effects like hoarseness, vocal cord paralysis, sorethroat. Some study revealed that 60cmH2O of intracuff pressure is maximum pressure which is not increase side effect.
The manufacturer recommends that the cuff is inflated with the minimum volume of air required to provide an effective seal(max volume - size 3, 20 ml; size 4, 30 ml; size 5, 40).
The investigators will measure anatomical structure (neck circumference, neck length, thyroid-mental distance, etc.) which can influence cuff volume and pressure and find correlation between cuff volume and physical figure measured.
- Conditions
- Anesthesia
- Being tested
- Classic laryngeal mask airway
- Keywords
- Laryngeal mask airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classic laryngeal mask airwayDevice
- measurement of head and neck
- Ht,Wt,BMI, neck circumference above a thyroid cartilage, mandible circumference( from the lower part of earlobe-mandible angle-mentum-mandible angle to the lower part of earlobe), neck length (mastoid tip~sternal notch), modified mallampati classification under sitting position, thyromental distance.
- laryngeal mask airway insertion and measuring cuff pressure by pressure transducer
- # 4.0 for female, #5.0 for male
- initial cuff volume(air) : maximum volume recommended by the manufacturer
- check pressure : if it exceed 60cmH20, we will remove air until 60cmH20
- remove air until gas leak occured around the cuff under airway pressure 15cmH20, fresh gas flow 6liters/min. Check the volume and pressure just before leakage occured.
| Study group | Role | What they receive |
|---|---|---|
| Classic laryngeal mask airway | Other | single arm Receives: Device: Classic laryngeal mask airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
optimal laryngeal mask airway cuff volume
◦The investigators remove air until gas leak occured around the cuff under airway pressure 15cm H20, fresh gas flow 6liters/min. Check the volume and pressure just before leakage occured.
Measured: 20minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hye-Won Shin, Korea University Anam Hospital
- Investigators
- Hye-Won Shin, MD, PhD, Study director, Department of anesthesiology and pain medicine, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502422
- Sponsor's protocol ID
- LMA60
- Acronym
- RCVPE
- Status last verified
- Feb 2016
- First submitted
- 16 Jul 2015
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Optimal Laryngeal Mask Airway Cuff Volume From Parameters of Physical Examination of Head and Neck
- ClinicalTrials.gov ID
- NCT02502422
- Acronym / sponsor ID
- RCVPE / LMA60
- Conditions
- Anesthesia
- Keywords
- Laryngeal mask airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Jul 2015 (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.
Overinflation of laryngeal mask airway cuff increase side effect like hoarseness, vocal cord paralysis, sorethroat. The investigators will study correlation between laryngeal mask airway cuff volume and pressure and physical examination of head and neck.
Detailed description
Overinflation of laryngeal mask airway cuff can induce side effects like hoarseness, vocal cord paralysis, sorethroat. Some study revealed that 60cmH2O of intracuff pressure is maximum pressure which is not increase side effect.
The manufacturer recommends that the cuff is inflated with the minimum volume of air required to provide an effective seal(max volume - size 3, 20 ml; size 4, 30 ml; size 5, 40).
The investigators will measure anatomical structure (neck circumference, neck length, thyroid-mental distance, etc.) which can influence cuff volume and pressure and find correlation between cuff volume and physical figure measured.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Classic laryngeal mask airway | Other | Device: Classic laryngeal mask airwaysingle arm |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (age 19-65)
- American Society of Anesthesiology Classification I-III
Key exclusion criteria (4 listed)
- cardiovascular disease, cerebrovascular disease, pulmonary disease
- patient who have operation history for airway
- patient who expected difficult intubation
- patient who have risk of aspiration
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 |
|---|---|---|
| Classic laryngeal mask airway1. measurement of head and neck * Ht,Wt,BMI, neck circumference above a thyroid cartilage, mandible circumference( from the lower part of earlobe-mandible angle-mentum-mandible angle to the lower part of earlobe), neck length (mastoid tip~sternal notch), modified mallampati classification under sitting position, thyromental distance. 2. laryngeal mask airway insertion and measuring cuff pressure by pressure transducer * # 4.0 for female, #5.0 for male * initial cuff volume(air) : maximum volume recommended by the manufacturer * check pressure : if it exceed 60cmH20, we will remove air until 60cmH20 * remove air until gas leak occured around the cuff under airway pressure 15cmH20, fresh gas flow 6liters/min. Check the volume and pressure just before leakage occured. | Device | Classic laryngeal mask airway |
Primary outcome
optimal laryngeal mask airway cuff volume
Time frame: 20minutes
◦The investigators remove air until gas leak occured around the cuff under airway pressure 15cm H20, fresh gas flow 6liters/min. Check the volume and pressure just before leakage occured.
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 17 Feb 2016.
- Individual participant dataSharing planned: Undecided
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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.
Hye-Won Shin, MD, PhD study director
Department of anesthesiology and pain medicine, Korea University Anam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classic laryngeal mask airway in people with Anesthesia, run by Korea University Anam Hospital at 1 site in South Korea.
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 17 Feb 2016. 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 South Korea. 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.
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?
optimal laryngeal mask airway cuff volume (time frame: 20minutes). 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 17 Feb 2016.