Comparison of Various Supraglottic Airway Devices for Fib... | NCT02501577

Studies
Comparison of Various Supraglottic Airway Devices for Fiberoptical Guided Tracheal Intubation

NCT02501577

Sponsor

University of Regensburg

Status

Unknown status

Last Update Posted

Jul 17, 2015Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Intubation; Difficult

Interventions

SAD 1
SAD 2

Countries

Germany

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

Jul 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Oct 2015Estimated

Completion Date

Oct 2015Estimated

First Submitted Date

Jul 9, 2015

First Submission Date that Met QC Criteria

Jul 16, 2015

First Posted Date

Jul 17, 2015Estimated

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

Jul 16, 2015

Last Update Posted Date

Jul 17, 2015Estimated

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

Placement of a supraglottic airway device Fiberoptical verification of pharyngeal position

Detailed Description

Feasibility for fiberoptical verification of pharyngeal position of supraglottic airway device

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SAD 1	Experimental	FOI for placement	Device: SAD 1
SAD 2	Experimental	FOI für placement	Device: SAD 2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SAD 1	Device	Placement and fiberoptic control	SAD 1
SAD 2

Measure	Description	Time Frame
Visibility of vocal cords		intraoperative

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

will to participate

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

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

Name	Role	Phone	Extension	Email
Thomas Metterlein, MD	Contact	+499419440		thomas.metterlein@ukr.de
Christoph Plank, MD	Contact	+499419440		christop.plank@ukr.de

Overall Officials

Name	Affiliation	Role
Thomas Metterlein, MD	Uni Regensburg	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Regensburg	Recruiting	Regensburg		93051	Germany