Anesthesia; FunctionalNCT02937337
Laryngeal Mask Airway With Video-stylet
A study testing Laryngeal mask insertion with videostylet guided technique and Laryngeal mask insertion with standard blind technique in people with Anesthesia; Functional, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In this randomized controlled trial, we aimed to compare the efficacy of video-stylet guided laryngeal mask airway real time insertion technique with the standard recommended index finger-guided insertion technique in pediatric patients. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Anesthesia; Functional
- What is being tested?
- Laryngeal mask insertion with videostylet guided technique and Laryngeal mask insertion with standard blind technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2016to Oct 2017
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric patients undergoing general anesthesia using laryngeal mask airways
Who cannot join
- recent (within 2 weeks) upper respiratory infection
Trial locations and contacts
1 site in 1 country.
Hee-Soo Kim, professor contact
About this study
Official title: Video Stylet Guided Laryngeal Mask Airway Insertion in Pediatrics: a Randomized Controlled Trial
In this randomized controlled trial, we aimed to compare the efficacy of video-stylet guided laryngeal mask airway real time insertion technique with the standard recommended index finger-guided insertion technique in pediatric patients.
Read the detailed description
Compare the efficacy and safety of using video-stylet guided laryngeal mask airway insertion with blind technique
- Conditions
- Anesthesia; Functional
- Being tested
- Laryngeal mask insertion with videostylet guided technique, Laryngeal mask insertion with standard blind technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal mask insertion with videostylet guided techniqueDevice
Laryngeal mask insertion with standard blind techniqueDevice
| Study group | Role | What they receive |
|---|---|---|
| Videostylet | Experimental | Laryngeal mask airway insertion using video stylet guided technique Receives: Device: Laryngeal mask insertion with videostylet guided technique |
| Blind | Active comparator | Laryngeal mask insertion using standard index finger-guided technique Receives: Device: Laryngeal mask insertion with standard blind technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time required for inserting the laryngeal mask airways
Measured: time interval between the caregiver picked up and put down the laryngeal mask airway an expected average of 30 seconds
Secondary outcomes (1)
the numbers of insertion attempt
Measured: interval between the caregiver picked up and put down the laryngeal mask airway an expected average of 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; FunctionalStudies of the same condition, open and under way.
- More trials run by Seoul National 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937337
- Sponsor's protocol ID
- H-1609-090-792
- Status last verified
- Oct 2016
- First submitted
- 17 Oct 2016
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Stylet Guided Laryngeal Mask Airway Insertion in Pediatrics: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02937337
- Acronym / sponsor ID
- H-1609-090-792
- Conditions
- Anesthesia; Functional
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 18 Oct 2016 (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.
In this randomized controlled trial, we aimed to compare the efficacy of video-stylet guided laryngeal mask airway real time insertion technique with the standard recommended index finger-guided insertion technique in pediatric patients.
Detailed description
Compare the efficacy and safety of using video-stylet guided laryngeal mask airway insertion with blind technique
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Videostylet | Experimental | Device: Laryngeal mask insertion with videostylet guided techniqueLaryngeal mask airway insertion using video stylet guided technique |
| Blind | Active comparator | Device: Laryngeal mask insertion with standard blind techniqueLaryngeal mask insertion using standard index finger-guided technique |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- pediatric patients undergoing general anesthesia using laryngeal mask airways
Key exclusion criteria (1 listed)
- recent (within 2 weeks) upper respiratory infection
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 |
|---|---|---|
| Laryngeal mask insertion with videostylet guided technique | Device | Videostylet |
| Laryngeal mask insertion with standard blind technique | Device | Blind |
Primary outcome
the time required for inserting the laryngeal mask airways
Time frame: time interval between the caregiver picked up and put down the laryngeal mask airway an expected average of 30 seconds
1 secondary outcome
the numbers of insertion attempt
Time frame: interval between the caregiver picked up and put down the laryngeal mask airway an expected average of 30 seconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 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.
Hee-Soo Kim, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal mask insertion with videostylet guided technique and Laryngeal mask insertion with standard blind technique in people with Anesthesia; Functional, run by Seoul National University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hee-Soo Kim, professor (02-2072-3664), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time required for inserting the laryngeal mask airways (time frame: time interval between the caregiver picked up and put down the laryngeal mask airway an expected average of 30 seconds). 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 19 Oct 2016.