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OpenTrials
Completed

NCT Number: NCT02531256

An Investigation of a New Laryngeal Mask Airway LMA Protector

Evaluation of LMA Protector

Completed

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Key information

Conditions

Airway Morbidity

Age range

21 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

KK Women's and Children's Hospital

Singapore, 229899

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LMA Protector

Device

Insertion of airway device for airway management during gynaecological procedure

Primary outcomes

  1. Number of insertion attempts

    Time frame: 5 minutes

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

Secondary outcomes

  1. Oropharyngeal Leak Pressure

    Time frame: 5 minutes

    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

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Acronym: LMA

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 24, 2015
Registry last updated
Mar 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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