NCT01789034

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 12, 2013

Status Verified

February 1, 2013

Enrollment Period

1.7 years

First QC Date

February 8, 2013

Last Update Submit

February 11, 2013

Conditions

Difficult IntubationComplications

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • incidence of difficult intubations in novices vs experts and complication in the overall cohort

    3 years

Eligibility Criteria

Age16 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Neurologico Besta

Milan, 20136, Italy

RECRUITING

Study Officials

  • Paolo Cortellazzi, MD

    Istituto Nazionale Neurologico Carlo Besta

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Cortellazzi, MD

CONTACT

+3902239paolo.cortellazzi@istituto-besta.it

Paolo Cortellazzi, MD

CONTACT

+29022394paolo.cortellazzi@istituto-besta.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Neuroanesthesia Department

Study Record Dates

First Submitted

February 8, 2013

First Posted

February 11, 2013

Study Start

June 1, 2011

Primary Completion

February 1, 2013

Study Completion

June 1, 2013

Last Updated

February 12, 2013

Record last verified: 2013-02

Locations

IT(1)