Prediction Accuracy for Langeal Mask Unique TM Size in Pe... | NCT04215302

Studies
Prediction Accuracy for Langeal Mask Unique TM Size in Pediatric Patient

NCT04215302

Sponsor

Indonesia University

Status

Completed

Last Update Posted

Jan 2, 2020Actual

Enrollment

66Actual

Phase

Not provided

Conditions

General Anaesthesia

Interventions

laryngeal mask

Countries

Indonesia

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

Dec 2019

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 17, 2019Actual

Primary Completion Date

Nov 5, 2019Actual

Completion Date

Nov 5, 2019Actual

First Submitted Date

Dec 30, 2019

First Submission Date that Met QC Criteria

Dec 30, 2019

First Posted Date

Jan 2, 2020Actual

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

Dec 30, 2019

Last Update Posted Date

Jan 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 study aimed to know the accuracy for laryngeal mask unique TM size to Malay pediatric race according to weight measurement recommended by manufacturer

Detailed Description

sixty-six pediatric subjects aged between 1 - 10 years old underwent general anesthesia using laryngeal mask Unique TM. Laryngeal mask inserted using the size based on subject's weight. Effectivity was confirmed if there is no air sound from patient's mouth, airway seal pressure ≥20 cmH2O, maximum inspiration pressure was ≤ 20 cmH2O, difference in expiration and inspiration tidal volume less than 5%, and there is no cuff appear in mouth.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
laryngeal mask size		laryngeal mask size determines according to weight measurement	Device: laryngeal mask

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laryngeal mask	Device	the size of laryngeal mask given to the patient was based on patient's weight measurement	laryngeal mask size

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
successful insertion of laryngeal mask	observe the sign of successful insertion of laryngeal mask	3 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged 1 -10 years old
Malay race
scheduled for general anesthesia procedure with laryngeal mask

Exclusion Criteria:

- disagree to be included in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

10 Years

Standard Ages

Child

Study Population

pediatric population aged 1 - 10 years old underwent general anesthesia procedure with laryngeal mask airway device

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher Kapuangan, MD	Indonesia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Indonesia University		Jakarta	DKI Jakarta	10430	Indonesia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26783527	Result	Michalek P, Donaldson W, Vobrubova E, Hakl M. Complications Associated with the Use of Supraglottic Airway Devices in Perioperative Medicine. Biomed Res Int. 2015;2015:746560. doi: 10.1155/2015/746560. Epub 2015 Dec 13.
25254120	Result	Takahoko K, Iwasaki H, Sasakawa T, Suzuki A, Matsumoto H, Iwasaki H. Unilateral hypoglossal nerve palsy after use of the laryngeal mask airway supreme. Case Rep Anesthesiol. 2014;2014:369563. doi: 10.1155/2014/369563. Epub 2014 Aug 31.

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