NCT03654924

Brief Summary

The aim of this study is to evaluate the airway seal of LMA during intraoperative manipulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

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

September 1, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2019

Completed
Last Updated

March 30, 2020

Status Verified

August 1, 2018

Enrollment Period

2.9 years

First QC Date

August 30, 2018

Last Update Submit

March 26, 2020

Conditions

Value of Continuous Pressure Monitoring in Laryngeal Mask

Keywords

LMALeakSore Throat

Outcome Measures

Primary Outcomes (1)

  • Utility of continuous LMA cuff pressure monitoring in dental surgery

    Measure of intra cuff pressure

    Intra-operatively

Study Arms (1)

Laryngeal Mask

EXPERIMENTAL

A pressure gauge will be connected to the LMA using a small cable to measure the LMA cuff pressure continuously.

Device: Laryngeal Mask

Interventions

Laryngeal MaskDEVICE

General anaesthesia using LMA will be performed as per standard procedure. A pressure gauge will be connected to the LMA using a small cable to measure the LMA cuff pressure continuously.

Laryngeal Mask

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • NUH patients who will undergo wisdom teeth extraction.

You may not qualify if:

  • Patients with tooth braces
  • Patients who are at risk of aspiration
  • Patients with missing any of incisor tooth
  • Pregnant woman
  • Non-English speaking patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Health System

Singapore, 119074, Singapore

Location

MeSH Terms

Conditions

Pharyngitis

Interventions

Laryngeal Masks

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Intubation, IntratrachealAirway ManagementTherapeuticsIntubationInvestigative TechniquesMasksProtective DevicesEquipment and SuppliesPersonal Protective EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Lian Kah Ti, MBBS, MMed

    National University Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Observational study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2018

First Posted

August 31, 2018

Study Start

September 1, 2016

Primary Completion

July 25, 2019

Study Completion

July 25, 2019

Last Updated

March 30, 2020

Record last verified: 2018-08

Locations

SG(1)