Laryngeal Mask AirwayNCT03224611
Usefulness of Light Wand-guided Insertion of Flexible Reinforced Laryngeal Mask Airway
A study testing light wand in people with Laryngeal Mask Airway, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Flexible LMA (Laryngeal mask airway) is very useful for variable situation but it is hard to insert in correct position because of it's flexible structure. Especially in classical way of manual LMA insertion, when the index finger could not guide the flexible LMA to the optimal position, we could not guarantee the… Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Laryngeal Mask Airway
- What is being tested?
- light wand
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2017to 30 Sep 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient need general anesthesia using LMA and belonged to the ASA(American society of Anesthesiologist) class I or II
Who cannot join
- The patient who has URI(upper respiratory infection) symptom within 14 days or
- The patient's BMI(body mass index) exceeds 35 kg/m2
- The patient has severe GERD(gastroesophageal reflux disease) or hiatus hernia
- The patient who has any contraindication for LMA insertion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usefulness of Light Wand-guided Insertion of Flexible Reinforced Laryngeal Mask Airway: Comparison With Conventional Blind-insertion
Flexible LMA (Laryngeal mask airway) is very useful for variable situation but it is hard to insert in correct position because of it's flexible structure. Especially in classical way of manual LMA insertion, when the index finger could not guide the flexible LMA to the optimal position, we could not guarantee the correct position of the LMA. Therefore several studies have been investigated to improve this.
The light wand is a kind of stylet which have a light on the tip. Recently some studies demonstrated the usefulness of the light wand which could be used for indicating correct position of the LMA. We hypothesised there will be two advantages if the light wand is used as a stylet of the flexible LMA. First the stylet could support the mildness of the flexible LMA, and second the lightness could confirm the correct position of the flexible LMA.
- Conditions
- Laryngeal Mask Airway
- Being tested
- light wand
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
light wandDevice
The light wand is used as a stylet of the flexible LMA. When the investigator inserts the flexible LMA in "light wand group", the correct position of the LMA is confirmed by the light.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The flexible LMA is inserted using "index finger technique" |
| Light wand group | Active comparator | The flexible LMA is inserted using light wand as a stylet Receives: Device: light wand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal leak pressure
The oropharyngeal leak pressure is measured by the pressure which the investigator could detect the audible sound by stethoscope on patient's cheek during the exhaust valve is closed and the fresh gas is allowed to flow into the lungs at 3 liters per minute.
Measured: 5 minutes after LMA is inserted
Secondary outcomes (1)
The grade of oropharyngeal view through the fiberoptic assessment
The position of the LMA was assessed by fiberoptic examination through an attachment between the LMA and the anesthetic circuit.
Measured: 5 minutes after LMA is inserted
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Aug 2017
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal Mask AirwayStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiyoung Yoo, Ajou University School of Medicine
- Investigators
- Ji Young Yoo, Principal investigator, Clinical assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224611
- Sponsor's protocol ID
- AJIRB-MED-OBS-17-108
- Status last verified
- Oct 2018
- First submitted
- 13 Jul 2017
- Last updated
- 17 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Light Wand-guided Insertion of Flexible Reinforced Laryngeal Mask Airway: Comparison With Conventional Blind-insertion
- ClinicalTrials.gov ID
- NCT03224611
- Acronym / sponsor ID
- AJIRB-MED-OBS-17-108
- Conditions
- Laryngeal Mask Airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 21 Jul 2017 (actual)
- 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.
Flexible LMA (Laryngeal mask airway) is very useful for variable situation but it is hard to insert in correct position because of it's flexible structure. Especially in classical way of manual LMA insertion, when the index finger could not guide the flexible LMA to the optimal position, we could not guarantee the correct position of the LMA. Therefore several studies have been investigated to improve this.
The light wand is a kind of stylet which have a light on the tip. Recently some studies demonstrated the usefulness of the light wand which could be used for indicating correct position of the LMA. We hypothesised there will be two advantages if the light wand is used as a stylet of the flexible LMA. First the stylet could support the mildness of the flexible LMA, and second the lightness could confirm the correct position of the flexible LMA.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The flexible LMA is inserted using "index finger technique" |
| Light wand group | Active comparator | Device: light wandThe flexible LMA is inserted using light wand as a stylet |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patient need general anesthesia using LMA and belonged to the ASA(American society of Anesthesiologist) class I or II
Key exclusion criteria (4 listed)
- The patient who has URI(upper respiratory infection) symptom within 14 days or
- The patient's BMI(body mass index) exceeds 35 kg/m2
- The patient has severe GERD(gastroesophageal reflux disease) or hiatus hernia
- The patient who has any contraindication for LMA insertion
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 |
|---|---|---|
| light wandThe light wand is used as a stylet of the flexible LMA. When the investigator inserts the flexible LMA in "light wand group", the correct position of the LMA is confirmed by the light. | Device | Light wand group |
Primary outcome
Oropharyngeal leak pressure
Time frame: 5 minutes after LMA is inserted
The oropharyngeal leak pressure is measured by the pressure which the investigator could detect the audible sound by stethoscope on patient's cheek during the exhaust valve is closed and the fresh gas is allowed to flow into the lungs at 3 liters per minute.
1 secondary outcome
The grade of oropharyngeal view through the fiberoptic assessment
Time frame: 5 minutes after LMA is inserted
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 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Ji Young Yoo principal investigator
Clinical assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing light wand in people with Laryngeal Mask Airway, run by Ajou University School of Medicine 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 1 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 Oct 2018. 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?
Oropharyngeal leak pressure (time frame: 5 minutes after LMA is inserted). 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 Oct 2018.