Observational Study With Investigation of Two Second Gene... | NCT02566291

Studies
Observational Study With Investigation of Two Second Generation Laryngeal Masks

NCT02566291

Sponsor

Johannes Gutenberg University Mainz

Status

Completed

Last Update Posted

Jan 24, 2017Estimated

Enrollment

364Actual

Phase

Not provided

Conditions

Airway Remodeling

Interventions

Success

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

Jan 2017

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

Jan 2015

Primary Completion Date

Jan 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Sep 30, 2015

First Submission Date that Met QC Criteria

Oct 1, 2015

First Posted Date

Oct 2, 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

Jan 22, 2017

Last Update Posted Date

Jan 24, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marc Kriege, MD, Marc Kriege, MD; Rüdiger Noppens, MD, Johannes Gutenberg University MainzPrincipal Investigator

Lead Sponsor

Johannes Gutenberg University MainzOTHER

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

In a observational study the second-generation laryngeal masks LMA Supreme and Ambu AuraGain are investigated.

Detailed Description

After approval from the local ethics committee, data were collected in a prospective, non- randomised study over a three-month period. When contra-indications for laryngeal mask use were absent anaesthesiologists used either Supreme (Teleflex Medical GmbH, Germany) or Gain (Ambu GmbH, Germany). Endpoints were the success rate and time to insertion.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

364Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Supreme Group		Measuring Success rate and Insertion Time	Device: Success
Gain Group		Measuring Success rate and Insertion Time	Device: Success

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Success	Device	Success rate and time for insertion	Gain Group Supreme Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success rate	overall and first attempt success rate	70-98 Percent

Secondary Outcomes

Measure	Description	Time Frame
Time for insertion		5-120 seconds
Leakage in ml.min		0-300 ml.min

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 Years
No concurrent participation in another study
capacity to consent
Present written informed consent of the research participant
Elective surgery under general anesthesia

Exclusion Criteria:

Age <18 years
Existing pregnancy
Lack of consent
inability to consent
emergency patients
Emergency situations in the context of a Difficult Airway Management
ASA classification> 3
situations where the possibility of accumulated gastric contents
Participation in another study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Inclusion criteria:

Age > 18 Years informed consent elective surgery undergoing general anesthesia non-pregnant

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc MK Kriege, MD	University JG, Mainz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anaesthesiology;		Mainz	Rhineland-Palatinate	D55131	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22871204	Result	Russo SG, Cremer S, Galli T, Eich C, Brauer A, Crozier TA, Bauer M, Strack M. Randomized comparison of the i-gel, the LMA Supreme, and the Laryngeal Tube Suction-D using clinical and fibreoptic assessments in elective patients. BMC Anesthesiol. 2012 Aug 7;12:18. doi: 10.1186/1471-2253-12-18.

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms