Laryngeal MasksNCT03028896
90° Rotation Technique for LMA FlexibleTM Insertion
A study testing 90° rotational technique in people with Laryngeal Masks, run by Seoul National University Bundang Hospital.
Trial summary
The 90° rotation technique is known to improve the success rate of conventional LMA but its effect in LMA FlexibleTM is not known. We tried to find if 90° rotation technique could increase the first attempt success rate of the insertion of LMA FlexibleTM compared to standard technique. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Laryngeal Masks
- What is being tested?
- 90° rotational technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2015to 19 Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists class I - II
- Scheduled for elective breast surgery under general anaesthesia using LMA FlexibleTM
Who cannot join
- known difficult airway
- mouth opening less than 2.5 cm
- limited extension of neck
- recent sore throat
- gastroesophageal reflux disease
About this study
Official title: Comparison of Standard Versus 90° Rotation Technique for LMA FlexibleTM Insertion
The 90° rotation technique is known to improve the success rate of conventional LMA but its effect in LMA FlexibleTM is not known. We tried to find if 90° rotation technique could increase the first attempt success rate of the insertion of LMA FlexibleTM compared to standard technique.
Read the detailed description
One hundred and sixteen adult patients undergoing breast surgery were randomized to the two insertion techniques. The ease of insertion was assessed by the success rate at the first attempt. Heart rate and mean blood pressure were recorded 1 min before and 1 min after insertion. Postoperative complications were checked.
- Conditions
- Laryngeal Masks
- Being tested
- 90° rotational technique
- Keywords
- LMA Flexible
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
90° rotational techniqueProcedure or surgery
the LMA FlexibleTM was rotated counter-clockwise through 90°
| Study group | Role | What they receive |
|---|---|---|
| standard | No intervention | In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt. |
| rotational | Experimental | After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx. Receives: Procedure: 90° rotational technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Attempt Success Rate
the first attempt success rate of insertion of LMA FlexibleTM
Measured: at induction
Secondary outcomes (3)
Insertion Time
time from passed mouth of the device to the effective ventilation after inflation of the cuff
Measured: at induction
Oropharyngeal Leak Pressure
audible leak during manual ventilation at mouth
Measured: at induction
Number of Participants With Blood Staining on the Laryngeal Mask Airway
Number of Participants with blood staining on the laryngeal mask airway.
Measured: post op 1min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start2 Apr 2015
- Primary completion4 Mar 2016
- Study completion19 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laryngeal MasksStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BON WOOK KOO, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028896
- Sponsor's protocol ID
- SNU-LMA
- Status last verified
- Feb 2022
- First submitted
- 19 Jan 2017
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koo BW, Oh AY, Hwang JW, Na HS, Min SW. Comparison of standard versus 90 degrees rotation technique for LMA Flexible insertion: a randomized controlled trial. BMC Anesthesiol. 2019 Jun 7;19(1):95. doi: 10.1186/s12871-019-0773-z.
PubMed 31170926
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Standard Versus 90° Rotation Technique for LMA FlexibleTM Insertion
- ClinicalTrials.gov ID
- NCT03028896
- Acronym / sponsor ID
- SNU-LMA
- Conditions
- Laryngeal Masks
- Keywords
- LMA Flexible
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 2 Apr 2015 (actual)
- Primary completion
- 4 Mar 2016 (actual)
- Study completion
- 19 Jan 2017 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Posted 26 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The 90° rotation technique is known to improve the success rate of conventional LMA but its effect in LMA FlexibleTM is not known. We tried to find if 90° rotation technique could increase the first attempt success rate of the insertion of LMA FlexibleTM compared to standard technique.
Detailed description
One hundred and sixteen adult patients undergoing breast surgery were randomized to the two insertion techniques. The ease of insertion was assessed by the success rate at the first attempt. Heart rate and mean blood pressure were recorded 1 min before and 1 min after insertion. Postoperative complications were checked.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard | No intervention | –In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt. |
| rotational | Experimental | Procedure: 90° rotational techniqueAfter insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists class I - II
- Scheduled for elective breast surgery under general anaesthesia using LMA FlexibleTM
Key exclusion criteria (5 listed)
- known difficult airway
- mouth opening less than 2.5 cm
- limited extension of neck
- recent sore throat
- gastroesophageal reflux disease
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 |
|---|---|---|
| 90° rotational techniquethe LMA FlexibleTM was rotated counter-clockwise through 90° | Procedure or surgery | rotational |
Primary outcome
First Attempt Success Rate
Time frame: at induction
the first attempt success rate of insertion of LMA FlexibleTM
3 secondary outcomes
Insertion Time
Time frame: at induction
Oropharyngeal Leak Pressure
Time frame: at induction
Number of Participants With Blood Staining on the Laryngeal Mask Airway
Time frame: post op 1min
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31170926Koo BW, Oh AY, Hwang JW, Na HS, Min SW. Comparison of standard versus 90 degrees rotation technique for LMA Flexible insertion: a randomized controlled trial. BMC Anesthesiol. 2019 Jun 7;19(1):95. doi: 10.1186/s12871-019-0773-z.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 90° rotational technique in people with Laryngeal Masks, run by Seoul National University Bundang Hospital.
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 5 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 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 26 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
First Attempt Success Rate (time frame: at induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03028896, which also lists 1 linked publication.
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 9 Feb 2022.