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CompletedNCT02531256LMAUpdated Aug 6, 2026

An Investigation of a New Laryngeal Mask Airway LMA Protector

An interventional study of LMA Protector in Airway Morbidity, sponsored by KK Women's and Children's Hospital. Completed at 1 site in Singapore. Open to female participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by KK Women's and Children's Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
21 Years to 70 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Airway Morbidity

Keywords

  • Laryngeal Mask Airway
03

In context

Lead sponsor

KK Women's and Children's Hospital is the lead sponsor of 136 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • planned elective surgery with indication for LMA use

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    LMA Protector

    Single Use Supraglottic Airway Device with 2 ports for gastric access (male and female port)

    Device: LMA Protector

Interventions

  • DeviceLMA Protector

    Insertion of airway device for airway management during gynaecological procedure

06

What researchers measure

Primary outcomes

  1. Number of insertion attempts

    Time of pickup of device to the presence of carbon dioxide trace on

    Time frame: 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

    Time frame: 5 minutes

07

Study locations

1 site
  • KK Women's and Children's Hospital
    Singapore, 229899, Singapore
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02531256
Lead sponsor
KK Women's and Children's Hospital
Responsible party
Sng Ban Leong (Principal Investigator, KK Women's and Children's Hospital) — Principal investigator
First posted
Aug 24, 2015
Start date
Jan 2014
Primary completion
Oct 2015
Completion
Dec 2015
Last update
Aug 6, 2026

Study contacts

Ban L Sng, FANZCA
principal investigator · KK Women's and Children's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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