Continuous Laryngeal Cuff Pressure Monitoring

March 26, 2020 updated by: National University Hospital, Singapore
The aim of this study is to evaluate the airway seal of LMA during intraoperative manipulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The laryngeal mask airway (LMA) is widely used in dental surgery as it provides an unobstructed airway and provides a reliable seal from bleeding and surgical debris. However, there have been few studies of the integrity of the LMA seal during intraoperative surgical manipulation with the use of the LMA.

In general anesthesia using LMA, airway and esophagus cannot be separated completely. Insufficient airway seal become the risk of aspiration in airway management. This study will focus on airway seal following LMA use in dental surgery.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 119074
        • National University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • NUH patients who will undergo wisdom teeth extraction.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Laryngeal Mask
A pressure gauge will be connected to the LMA using a small cable to measure the LMA cuff pressure continuously.
Device: Laryngeal Mask
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Utility of continuous LMA cuff pressure monitoring in dental surgery
Time Frame: Intra-operatively
Measure of intra cuff pressure
Intra-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Investigators

  • Principal Investigator: Lian Kah Ti, MBBS, MMed, National University Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2016

Primary Completion (ACTUAL)

July 25, 2019

Study Completion (ACTUAL)

July 25, 2019

Study Registration Dates

First Submitted

August 30, 2018

First Submitted That Met QC Criteria

August 30, 2018

First Posted (ACTUAL)

August 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 26, 2020

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DSRB 2016/00604

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Study protocol, results, analysis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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