An Investigation of a New Laryngeal Mask Airway LMA Protector

Airway Morbidity Clinical Trial

— LMA  

Official title:

An Investigation of a New Laryngeal Mask Airway LMA Protector

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02531256
• Other study ID #: 2013/709/D
• Status: Completed
• Phase: N/A
• First received: August 21, 2015
• Last updated: February 28, 2016
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: August 2015
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Evaluation of LMA Protector

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Airway Morbidity

Intervention

Device:
• LMA Protector
Insertion of airway device for airway management during gynaecological procedure

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of insertion attempts	Time of pickup of device to the presence of carbon dioxide trace on	5 minutes	No
Secondary	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	5 minutes	Yes