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Continuous Laryngeal Cuff Pressure Monitoring

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03654924
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

Study Description
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Brief Summary:
The aim of this study is to evaluate the airway seal of LMA during intraoperative manipulation.

Condition or disease Intervention/treatment Phase
Value of Continuous Pressure Monitoring in Laryngeal Mask Device: Laryngeal Mask Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Observational study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Continuous Laryngeal Cuff Pressure Monitoring
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : July 25, 2019
Actual Study Completion Date : July 25, 2019
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Utility of continuous LMA cuff pressure monitoring in dental surgery [ Time Frame: Intra-operatively ]
    Measure of intra cuff pressure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654924


Locations
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Singapore
National University Health System
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
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Principal Investigator: Lian Kah Ti, MBBS, MMed National University Health System
More Information
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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT03654924    
Other Study ID Numbers: DSRB 2016/00604
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Study protocol, results, analysis

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National University Hospital, Singapore:
LMA
Leak
Sore Throat