NCT02531256

Brief Summary

Evaluation of LMA Protector

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 1, 2016

Status Verified

August 1, 2015

Enrollment Period

1.7 years

First QC Date

August 21, 2015

Last Update Submit

February 28, 2016

Conditions

Airway Morbidity

Keywords

Laryngeal Mask Airway

Outcome Measures

Primary Outcomes (1)

  • Number of insertion attempts

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

    5 minutes

Secondary Outcomes (1)

  • Oropharyngeal Leak Pressure

    5 minutes

Study Arms (1)

LMA Protector

EXPERIMENTAL

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

Device: LMA Protector

Interventions

LMA ProtectorDEVICE

Insertion of airway device for airway management during gynaecological procedure

LMA Protector

Eligibility Criteria

Age21 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • planned elective surgery with indication for LMA use

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore, 229899, Singapore

Location

Related Publications (1)

  • 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.

    PMID: 28219323DERIVED

Study Officials

  • Ban L Sng, FANZCA

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2015

First Posted

August 24, 2015

Study Start

January 1, 2014

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

March 1, 2016

Record last verified: 2015-08

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)