Skip to content

An Investigation of a New Laryngeal Mask Airway LMA Protector

An Investigation of a New Laryngeal Mask Airway LMA Protector

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02531256
Acronym
LMA
Enrollment
40
Registered
2015-08-24
Start date
2014-01-31
Completion date
2015-12-31
Last updated
2016-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Morbidity

Keywords

Laryngeal Mask Airway

Brief summary

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.

Interventions

Insertion of airway device for airway management during gynaecological procedure

Sponsors

KK Women's and Children's Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* planned elective surgery with indication for LMA use

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

Design outcomes

Primary

MeasureTime frameDescription
Number of insertion attempts5 minutesTime of pickup of device to the presence of carbon dioxide trace on

Secondary

MeasureTime frameDescription
Oropharyngeal Leak Pressure5 minutesClosure 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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026