Clasic Laryngeal Mask Airway(C-LMA) and I-gel Releated Re... | NCT01876836

Studies
Clasic Laryngeal Mask Airway(C-LMA) and I-gel Releated Regurgitation and Complications

NCT01876836

Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Status

Unknown status

Last Update Posted

Jun 13, 2013Estimated

Enrollment

120Estimated

Phase

Phase 4

Conditions

Bladder Tumour
Prostate Hyperplasia

Interventions

i-gel
C-LMA

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

Jun 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

Jul 2013

Primary Completion Date

Aug 2013Estimated

Completion Date

Sep 2013Estimated

First Submitted Date

Jun 10, 2013

First Submission Date that Met QC Criteria

Jun 11, 2013

First Posted Date

Jun 13, 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

Jun 11, 2013

Last Update Posted Date

Jun 13, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Reyhan Polat, 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)

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

i-gel
C-LMA

Compare the effect on gastroeosephageal reflux Postoperative complicatios.

Detailed Description

120 ASA I-II adult patients. Patients were randomised into two groups

i-gel
C-LMA Volume controlled ventilation, general anesthesia Asses Gastroeosephageal reflux, sore throat, coughing, dysphagia,dysphonia recorded.

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

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
i-gel	Experimental	i-gel placed after induction	Device: i-gel
C-LMA	Active Comparator	C-LMA placed after induction	Device: C-LMA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
i-gel	Device	i-gel placed after induction	i-gel	supraglottic airway device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ph MEASUREMENT	The ph of the secretions on the airway device will be measurd with a Ph-meter	1 MİNUTE AFTER EXTUBATİON

Secondary Outcomes

Measure	Description	Time Frame
Bleu dye on the airway device	The airway device will be examined with fiberoptic endoscope after placement	5 min after placenent

Other Outcomes

Measure	Description	Time Frame
Blue dye on airway device	the airway device will be examined for a precence of blue dye	1 min after extubation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I-II
Adult
Elective surgery
Bladder tumour
Prostat hyperplasi

Exclusion Criteria:

Emergency surgery
Hiatal hernia
Gastroeosephageal reflux disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Reyhan Polat, MD	Contact	+905326734310		reyhanp9@gmail.com

Overall Officials

Name	Affiliation	Role
Reyhan Polat, MD	Diskapi Yildirim Beyazit Education and Research Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
DiskapiYBERH		Ankara	Altındağ	06610	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D001749	Urinary Bladder Neoplasms
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided