Difficult Intubation With Glidescope Video Laryngoscope | NCT01789034

Studies
Difficult Intubation With Glidescope Video Laryngoscope

NCT01789034

Sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Status

Unknown status

Last Update Posted

Feb 12, 2013Estimated

Enrollment

2,600Estimated

Phase

Not provided

Conditions

Difficult Intubation
Complications

Interventions

Not provided

Countries

Italy

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 2013

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

Jun 2011

Primary Completion Date

Feb 2013Actual

Completion Date

Jun 2013Estimated

First Submitted Date

Feb 8, 2013

First Submission Date that Met QC Criteria

Feb 8, 2013

First Posted Date

Feb 11, 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

Feb 11, 2013

Last Update Posted Date

Feb 12, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Massimo Lamperti, MD, Neuroanesthesia Department, Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaPrincipal Investigator

Lead Sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaOTHER

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

A prospective observational study on predictors available and on variables of difficult intubation adopting Gliscope video laryngoscope routinely.

Primary hypothesis of the current study is that the rate of difficult intubation with Glidescope is low and multiple predictors interact favorably in anticipating difficulties.

Detailed Description

All possible factors involved in difficult intubations were included in this prospective analysis.

Main predictors were considered: time to Cormack Lane using Glidescope intubation, Cormack Lane score, experience of the operator (staff or resident), number of bag mask ventilation, number of intubation attempts.

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

2,600Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of difficult intubation using Adnet score modified	Difficult intubation in the current study is measured using Adnet score including the number of laryngoscopies	3 years

Secondary Outcomes

Measure	Description	Time Frame
incidence of difficult intubations in novices vs experts and complication in the overall cohort		3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

any patient up to ASA4 eligible for intubation for neurosurgical procedures
any anesthesiologist in charge for GA

Exclusion Criteria:

children
patient not suitable for clinical evaluation of predictors for difficult intubation (ie. Parkinson's disease)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients undergoing neurosurgical procedures eligible for intubation in a tertiary neurosurgical centre

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Paolo Cortellazzi, MD	Contact	+3902239	2420	paolo.cortellazzi@istituto-besta.it
Paolo Cortellazzi, MD	Contact	+29022394	2420	paolo.cortellazzi@istituto-besta.it

Overall Officials

Name	Affiliation	Role
Paolo Cortellazzi, MD	Istituto Nazionale Neurologico Carlo Besta	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Neurologico Besta	Recruiting	Milan		20136	Italy