Comparison of Intubation Conditions Between the Gliderite... | NCT02519647

Studies
Comparison of Intubation Conditions Between the Gliderite and the S-Guide

NCT02519647

Sponsor

University of Lausanne Hospitals

Status

Completed

Last Update Posted

Mar 2, 2020Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Nasal Obstruction
Lumbar Stenosis, Familial

Interventions

Tracheal intubation with Gliderite
Tracheal intubation with S-guide

Countries

Switzerland

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

Feb 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 1, 2015Actual

Primary Completion Date

May 2, 2016Actual

Completion Date

Jun 2, 2016Actual

First Submitted Date

Jul 27, 2015

First Submission Date that Met QC Criteria

Aug 10, 2015

First Posted Date

Aug 11, 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

Feb 27, 2020

Last Update Posted Date

Mar 2, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Patrick Schoettker,MD PD, MD, PD, University of Lausanne HospitalsPrincipal Investigator

Lead Sponsor

University of Lausanne HospitalsOTHER

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

Intubation with an unchanneled videolaryngoscope mandates the use of a stylet. The Gliderite is a stylet specially designed for videolaryngoscopes. The investigators aim to compare the efficacy of a new designed bougie for intubation in patients with simulated difficult airways.

Detailed Description

The primary endpoint will be time necessary for intubation, secondary endpoints will be injuries, ease of use and subjective assessment.

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

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tracheal intubation with Gliderite	Active Comparator	Gliderite will be used for intubation	Device: Tracheal intubation with Gliderite
Tracheal intubation with S-Guide	Experimental	S-Guide will be used for intubation	Device: Tracheal intubation with S-guide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tracheal intubation with Gliderite	Device	Tracheal intubation with Gliderite	tracheal intubation with Gliderite

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time necessary to intubate	Time needed to pass tracheal tube through vocal cords	50 seconds

Secondary Outcomes

Measure	Description	Time Frame
Standardized questionnaire assessing injury after intubation	Assessment of discomfort after procedure	50 seconds
Standardized questionnaire assessing ease of use of the intubation	assessment by doctor of ease of intubation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Surgery necessitating general anesthesia and orotracheal intubation

Exclusion Criteria:

History or criteria of difficult intubation
Patient refusal

Accepts Healthy Volunteers

Yes

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
patrick Schoettker, MD, PD	University of Lausanne Hospitals	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dpt of Anesthesiology, University of Lausanne CHUV		Lausanne	Canton of Vaud	1011	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D015508	Nasal Obstruction
C563613	Lumbar Stenosis, Familial

Ancestor Terms

ID	Term
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D000402	Airway Obstruction
D012131	Respiratory Insufficiency

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007442	Intubation, Intratracheal

Ancestor Terms

ID	Term
D058109	Airway Management
D013812	Therapeutics
D007440	Intubation
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided