Difficult Intubation With Glidescope Video Laryngoscope

Complications Clinical Trial

Official title:

Incidence and Predictors of Difficult Intubation Adopting an Institutional Algorithm Glidescope Based: a Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01789034
• Other study ID #: Besta-2012-01
• Status: Recruiting
• Phase: N/A
• First received: February 8, 2013
• Last updated: February 11, 2013
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: February 2013
• Source: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Contact: Paolo Cortellazzi, MD
• Phone: +3902239
• Email: paolo.cortellazzi[@]istituto-besta.it
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2600
• Est. completion date: June 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 85 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Complications
• Difficult Intubation

Locations

Country	Name	City	State
Italy	Istituto Neurologico Besta	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	incidence of difficult intubations in novices vs experts and complication in the overall cohort		3 years	Yes