Does Laryngoscopic Tecnique Facilitate cLMA Insertion? | NCT02000791

Studies
Does Laryngoscopic Tecnique Facilitate cLMA Insertion?

NCT02000791

Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Status

Unknown status

Last Update Posted

Dec 4, 2013Estimated

Enrollment

180Estimated

Phase

Phase 4

Conditions

Urologic Surgery

Interventions

Comparison of fibreoptic view

Countries

Turkey (Türkiye)

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

Nov 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Feb 2014Estimated

Completion Date

May 2014Estimated

First Submitted Date

Nov 21, 2013

First Submission Date that Met QC Criteria

Dec 3, 2013

First Posted Date

Dec 4, 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

Dec 3, 2013

Last Update Posted Date

Dec 4, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tugba Arslan, medical doctor, Diskapi Yildirim Beyazit Education and Research HospitalPrincipal Investigator

Lead Sponsor

Diskapi Yildirim Beyazit Education and Research HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

it is compared that laryngeal mask insertion with standard technique and laryngoscopic technique

Detailed Description

Is there any releation between insertion succes rate and difficult intubation criteria. success of the first attempt laryngeal mask insertion, patient response of laryngeal mask placement. And also during the implementation of these two techniques; the effects on heart rate and blood pressure and postoperative complications were investigated.

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

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cLMA insertion via laryngoscopic technique	Experimental	Comparison of cLMA insertion via laryngoscope view by fiberscope	Other: Comparison of fibreoptic view
cLMA insertion via standart technique	Active Comparator	Comparison of cLMA insertion via standart technique view by fiberscope	Other: Comparison of fibreoptic view

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Comparison of fibreoptic view	Other		cLMA insertion via laryngoscopic technique cLMA insertion via standart technique

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
İnvestigate to easy of insertion whether standart or laryngoscopic technique		1 min after insertion

Secondary Outcomes

Measure	Description	Time Frame
Fiberoptic view		1 min after insertion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over 18 age
under urologic surgery patient

Exclusion Criteria:

Uper respiratory infection
Full stomach
BMI over 40

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tuğba Arslan, MD	Contact	+905074378919		tuba.kokulu@gmail.com

Overall Officials

Name	Affiliation	Role
Tugba Arslan, MD		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Diskapi Yildiim Beyazit Eduation and Research Hospital		Ankara			Turkey (Türkiye)