Supreme LMA and Proseal LMA in Prone Anesthetized Patient | NCT01814306

Studies
Supreme LMA and Proseal LMA in Prone Anesthetized Patient

NCT01814306

Sponsor

Prince of Songkla University

Status

Unknown status

Last Update Posted

Mar 19, 2013Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Inadequate or Impaired Breathing Pattern or Ventilation

Interventions

Supreme LMA
Proseal LMA

Countries

Thailand

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

ID	Type	Description	Link
SPLMA-100-CPrechawai	Registry Identifier	CPrechawai

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Apr 2013Estimated

Completion Date

Jun 2013Estimated

First Submitted Date

Feb 12, 2013

First Submission Date that Met QC Criteria

Mar 15, 2013

First Posted Date

Mar 19, 2013Estimated

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 15, 2013

Last Update Posted Date

Mar 19, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chatchai Prechawai, Anesthesiology Department, Prince of Songkla UniversityPrincipal Investigator

Lead Sponsor

Prince of Songkla UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

There is no significant difference about success rate of two devices.

Detailed Description

There is no significant difference about success rate of two device: efficacy and safety

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Supreme	Active Comparator	Supreme LMA	Device: Supreme LMA
Proseal	Active Comparator	Proseal LMA	Device: Proseal LMA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Supreme LMA	Device	Use Supreme LMA to compare efficay with Proseal LMA in prone position insertion	Supreme

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success rate of insertion (quality of ventilation)		1 year

Secondary Outcomes

Measure	Description	Time Frame
Ease of insertion, Complication and Glottic seal pressure		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society Anesthesiologists physical status I-III
Patient undergo elective orthopedics surgery in prone position under general anaesthesia

Exclusion Criteria:

Age <15year
Non-fast
Morbid obesity (BMI > 35kg/m2)
Pregnancy
Known or predicted difficult airway
GERD
History of laryngeal problem (injury,subglottic stenosis)
Local pharyngeal problem (abscess,tumor)
Poor dentation
Pulmonary disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chatchai Prechawai	Prince of Songkla University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Prince of Songkla University		Hat Yai	Changwat Songkhla	90110	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided