Clinical Evaluation of the Revised iLTS-D2 | NCT03942809

Studies
Clinical Evaluation of the Revised iLTS-D2

NCT03942809

Sponsor

Johannes Gutenberg University Mainz

Status

Completed

Last Update Posted

Apr 28, 2020Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Airway Management

Interventions

Effectiveness

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

Apr 2020

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

Aug 13, 2019Actual

Primary Completion Date

Mar 30, 2020Actual

Completion Date

Apr 15, 2020Actual

First Submitted Date

Apr 22, 2019

First Submission Date that Met QC Criteria

May 7, 2019

First Posted Date

May 8, 2019Actual

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

Apr 26, 2020

Last Update Posted Date

Apr 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marc Kriege, MD, Principal investigator, 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

Is FDA Regulated Device

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

A interventional, non-randomized, controlled study to evaluate the revised iLTS-D2 in anesthetized patients.

Detailed Description

The revised Intubation laryngeal tube - disposable (iLTS-D) is a refined laryngeal tube, which allows a secondary intubation over the inserted laryngeal tube. The present study should reveal the effectiveness and practicability in anesthetized patients in the operation room.

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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Effectiveness	Experimental	Evaluate the Effectiveness in insertion success, insertion times, influence of respiratory, cardiac and cerebral circulation	Device: Effectiveness

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Effectiveness	Device	Effectiveness and Practicability in anesthetized patient under controlled conditions	Effectiveness

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Insertion time LT	Insertion of the laryngeal tube	in 30 seconds

Secondary Outcomes

Measure	Description	Time Frame
Insertion time ET	Insertion of the endotracheal tube	in 60 seconds
Rate of successful Intubation attempts	successful insertion and tracheal intubation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elective surgery patients under general Anesthesia

Exclusion Criteria:

Age <18 years
Existing pregnancy
Lack of consent
inability to consent
emergency patients

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc Kriege, MD	University Medical Center Mainz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University		Mainz	Rhineland-Palatinate	D55131	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided