Airway MorbidityLMANCT02531256
An Investigation of a New Laryngeal Mask Airway LMA Protector
A study testing LMA Protector in people with Airway Morbidity, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
Evaluation of LMA Protector Read more about this study
- Who is it for?
- Ages 21 to 70 years, women only
- Conditions the study is for
- Airway Morbidity
- What is being tested?
- LMA Protector
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2014to 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 21 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- planned elective surgery with indication for LMA use
Who cannot join
- body mass index of 30 or more, known gastro-oesophageal reflux, patients with increased risk of aspiration, upper airway pathology and mouth opening of less than 2 cm
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of LMA Protector
Read the detailed description
This new disposable silicone airway device provides access and functional separation of the respiratory and digestive tracts. The airway tube is elliptical in cross section ending at the laryngeal opening. The device contains 2 drainage channels (male and female port) proximally that continues into a common distal opening posterior to the distal airway cuff bowl. The female port allows a gastric tube to be passed into the stomach, whilst a suction tube may be attached to the male suction port offering removal of gastric fluid around the upper oesophagus sphincter.
- Conditions
- Airway Morbidity
- Being tested
- LMA Protector
- Keywords
- Laryngeal Mask Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA ProtectorDevice
Insertion of airway device for airway management during gynaecological procedure
| Study group | Role | What they receive |
|---|---|---|
| LMA Protector | Experimental | Single Use Supraglottic Airway Device with 2 ports for gastric access (male and female port) Receives: Device: LMA Protector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of insertion attempts
Time of pickup of device to the presence of carbon dioxide trace on
Measured: 5 minutes
Secondary outcomes (1)
Oropharyngeal Leak Pressure
Closure of expiratory valve of circle anaesthetic breathing system and noting the airway pressure in the breathing system at equilibration with cuff pressure of 60cmH2O or up to maximum of 40cmH2O
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2015 (estimated)
- Study startJan 2014
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway MorbidityStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sng Ban Leong, KK Women's and Children's Hospital
- Investigators
- Ban L Sng, FANZCA, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531256
- Sponsor's protocol ID
- 2013/709/D
- Acronym
- LMA
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2015
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sng BL, Ithnin FB, Mathur D, Lew E, Han NR, Sia AT. A preliminary assessment of the LMA protector in non-paralysed patients. BMC Anesthesiol. 2017 Feb 20;17(1):26. doi: 10.1186/s12871-017-0323-5.
PubMed 28219323
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of a New Laryngeal Mask Airway LMA Protector
- ClinicalTrials.gov ID
- NCT02531256
- Acronym / sponsor ID
- LMA / 2013/709/D
- Conditions
- Airway Morbidity
- Keywords
- Laryngeal Mask Airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- Jan 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Aug 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.
Evaluation of LMA Protector
Detailed description
This new disposable silicone airway device provides access and functional separation of the respiratory and digestive tracts. The airway tube is elliptical in cross section ending at the laryngeal opening. The device contains 2 drainage channels (male and female port) proximally that continues into a common distal opening posterior to the distal airway cuff bowl. The female port allows a gastric tube to be passed into the stomach, whilst a suction tube may be attached to the male suction port offering removal of gastric fluid around the upper oesophagus sphincter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LMA Protector | Experimental | Device: LMA ProtectorSingle Use Supraglottic Airway Device with 2 ports for gastric access (male and female port) |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- planned elective surgery with indication for LMA use
Key exclusion criteria (1 listed)
- body mass index of 30 or more, known gastro-oesophageal reflux, patients with increased risk of aspiration, upper airway pathology and mouth opening of less than 2 cm
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 ProtectorInsertion of airway device for airway management during gynaecological procedure | Device | LMA Protector |
Primary outcome
Number of insertion attempts
Time frame: 5 minutes
Time of pickup of device to the presence of carbon dioxide trace on
1 secondary outcome
Oropharyngeal Leak Pressure
Time frame: 5 minutes
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 6 Aug 2026.
- Derived from this study: PubMed 28219323Sng BL, Ithnin FB, Mathur D, Lew E, Han NR, Sia AT. A preliminary assessment of the LMA protector in non-paralysed patients. BMC Anesthesiol. 2017 Feb 20;17(1):26. doi: 10.1186/s12871-017-0323-5.
- 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.
Ban L Sng, FANZCA principal investigator
KK Women's and Children's 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 LMA Protector in people with Airway Morbidity, run by KK Women's and Children's Hospital at 1 site in Singapore.
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: finished, as of the sponsor's last update on 6 Aug 2026. 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 Singapore. 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?
Number of insertion attempts (time frame: 5 minutes). 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 NCT02531256, 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 6 Aug 2026.