Continuous Laryngeal Cuff Pressure Monitoring | NCT03654924

Studies
Continuous Laryngeal Cuff Pressure Monitoring

NCT03654924

Sponsor

National University Hospital, Singapore

Status

Completed

Last Update Posted

Mar 30, 2020Actual

Enrollment

51Actual

Phase

Not Applicable

Conditions

Value of Continuous Pressure Monitoring in Laryngeal Mask

Interventions

Laryngeal Mask

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2016Actual

Primary Completion Date

Jul 25, 2019Actual

Completion Date

Jul 25, 2019Actual

First Submitted Date

Aug 30, 2018

First Submission Date that Met QC Criteria

Aug 30, 2018

First Posted Date

Aug 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2020

Last Update Posted Date

Mar 30, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Laryngeal Mask	Device	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lian Kah Ti, MBBS, MMed	National University Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National University Health System		Singapore		119074	Singapore

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Study protocol, results, analysis

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010612	Pharyngitis

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010608	Pharyngeal Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017214	Laryngeal Masks

Ancestor Terms

ID	Term
D007442	Intubation, Intratracheal
D058109	Airway Management
D013812	Therapeutics
D007440	Intubation

Browse Leaves

Not provided

Browse Branches

Not provided