Comparison of Two Insertion Technique of I-gel | NCT01826565

Studies
Comparison of Two Insertion Technique of I-gel

NCT01826565

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

May 6, 2013Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Prostate Cancer
Prostate Tumor
Bladder Cancer
Bladder Tumor

Interventions

Rotational technique

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 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

May 2013

Primary Completion Date

May 2014Estimated

Completion Date

Jul 2014Estimated

First Submitted Date

Mar 19, 2013

First Submission Date that Met QC Criteria

Apr 3, 2013

First Posted Date

Apr 8, 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

May 3, 2013

Last Update Posted Date

May 6, 2013Estimated

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

To evaluate the efficacy of rotational technique in the insertion of i-gel

Detailed Description

The i-gel is one of the 2nd generation supraglottic airways. The rotational technique is known to increase the success rate of insertion of other supraglottic airways. The investigators try to evaluate the efficacy of rotational technique in the insertion of i-gel.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	i-gel will be inserted without rotation
Rotation	Experimental	Rotational technique applied	Procedure: Rotational technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rotational technique	Procedure	90 degree rotation	Rotation	90 degree rotation technique

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The success rate of insertion	check oropharyngeal leakage at pressure 12 cmH2O	up to 30 min.

Secondary Outcomes

Measure	Description	Time Frame
postoperative sore throat	severe/moderate/minimal/none	up to 2 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Patients scheduled for general anesthesia(transurethral resection of bladder tumor or transurethral resection of the prostate) using i-gelTM

Exclusion Criteria:

History of recent postoperative sore throat
History of difficult airway
Mouth opening < 2.5 cm
Emergency operation

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hee-Pyung Park, MD PhD	Seoul National University of Hospital	Principal Investigator
Hyun-Chang Kim, MD	Seoul National University of Hospital	Principal Investigator

Locations

Not provided

Type	Date	Date Unknown
Release	Mar 17, 2014
Reset	Apr 18, 2014

Submission Tracking

Estimated Results First Submitted Date

Mar 17, 2014

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 17, 2014			Apr 18, 2014

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D001749	Urinary Bladder Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided