Learning and Performance of Glidescope® Videolaryngoscope Intubation

Anesthesia Intubation Complication Clinical Trial

Official title:

Learning and Performance of Glidescope® Videolaryngoscope Intubation in Anesthesiologists Trained in Direct Laryngoscopy: a "in Vivo" Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01790646
• Other study ID #: INCCB 2012-02
• Status: Recruiting
• Phase: N/A
• First received: February 8, 2013
• Last updated: February 12, 2013
• Start date: September 2012
• Est. completion date: May 2013

Study information

• Verified date: February 2013
• Source: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Contact: Paolo Cortellazzi, MD
• Phone: +39022394
• Email: paolo.cortellazzi[@]istituto-besta.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Glidescope laryngoscope was introduced as a novel tool for difficult intubation. Its learning curve was prooved on manikin but not in adult patients.

Description:

Glidescope® Videolaryngoscope is an angulated rigid optical device introduced in clinical practice in 2004 to facilitate endotracheal intubation.

Since its introduction potential benefits of this instrument might lie with use in patients with clinical features indicating difficult laryngoscopy or it being used as a rescue method following failed direct laryngoscopy. In a few centers was proposed and used routinely.

The performance of Glidescope® was studied in easy and difficult scenarios, in vivo and on manikins and compared with the reference standard McIntosh direct laryngoscopy. In patients with predicted or simulated difficult intubation, despite glottis visualization was improved with Glidescope®, the introduction of the tube in trachea was difficult the same as with McIntosh laryngoscopy. Training of operators before to entertain the trials varied from 20 to 50 Glidescope successful intubations. In an observational study Aziz et al. demonstrated in the two Institutions involved that the GlideScope® was used more frequently at the Institution were the failure rate was significantly lower. At this , 51 providers performed mean 21.7 GlideScope® intubations while at the other 91 providers performed 9.9 intubations.

These data highlight the important issue of how many Glidescope® intubations a provider should complete to reach a definitive clinical competence in this practice. Until now there is only one study performed on mankin comparing Glidescope® with AirTraq® and McIntosh laryngoscopes in novices . The authors concluded that despite a steep learning curve after 5 intubation difficulties in instrumentation and longer times to intubate persisted with Glidescope® in comparison with the other two devices. Outcome measures were: duration of intubation attempt, modified Cormack grades, dental trauma and difficulty of use.

In vivo both timely insertion of laryngoscope blade and introduction of the tube, no need of help or of external laryngeal displacement should be included to ascertain expertise with this new technology in patients with different grades of difficulty predicted.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 85 Years

Eligibility

Inclusion Criteria:

• any patient undergoing GA

Exclusion Criteria:

• patients with predicted difficult intubation undergoing awake intubation

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia Intubation Complication

Intervention

Other:
• intubation
intubation using Glidescope videolaryngoscope

Locations

Country	Name	City	State
Italy	Istituto Neurologico Besta	Milan
Italy	Istituto Neurologico Besta	Milano
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	number of attempts with Glidescope laryngoscopy necessary for beeing considered proficient	from Glidescope blade insertion to succefull introduction of the tracheal tube and tube secured in the trachea with ETCO2 confirmation of tracheal ventilation	from induction of GA to successful intubation	Yes
Secondary	Features useful to define a Glidescope intubation successful	the following criteria have to be satisfied: one introduction of the laryngoscope, one introduction of the tube, Cormack-leane 1, no external laryngeal displacement, time to intubation <43 seconds, no need for help of an external operator, no complications	successfull intubation	Yes