Laryngeal Mask Airway for Adenoidectomies (LMAA) | NCT02708043

Studies
Laryngeal Mask Airway for Adenoidectomies (LMAA)

NCT02708043

Sponsor

Baskent University

Status

Completed

Last Update Posted

Mar 15, 2016Estimated

Enrollment

814Actual

Phase

Phase 4

Conditions

Adenoidectomy Surgery
Flexible-Laryngeal Mask Airway

Interventions

Flexible-Laryngeal Mask Airway

Countries

Not provided

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

Mar 2016

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

Jun 2012

Primary Completion Date

Nov 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Feb 21, 2016

First Submission Date that Met QC Criteria

Mar 9, 2016

First Posted Date

Mar 15, 2016Estimated

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 9, 2016

Last Update Posted Date

Mar 15, 2016Estimated

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

The current study retrospectively assesses laryngeal mask airway use during pediatric adenoidectomies in terms of patient safety, comfort, complications and surgeon satisfaction levels.

Detailed Description

Not provided

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

814Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
F-LMA group	Other	LMA were placed to 814 patients for adenoidectomy surgery. Researchers evaluated flexible laryngeal mask airway use during pediatric adenoidectomies in terms of patient safety, comfort, complications and surgeon satisfaction levels.	Other: Flexible-Laryngeal Mask Airway

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Flexible-Laryngeal Mask Airway	Other		F-LMA group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence of failed LMA (0=failed, 1=good)		3 year

Secondary Outcomes

Measure	Description	Time Frame
Surgeon satisfaction level (0=bad, 1=same, 2=good)		3 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1-16 years of age
ASA I-II
Scheduled for elective adenoidectomy under general anesthesia with F-LMA between June 2012 and November 2015.

Exclusion Criteria:

Emergency
Extreme obesity
Sign of clinical significant infection.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided