Clinical trial NCT01790646: Learning and Performance of Glidescope® Videolaryngoscope Intubation
Official title: Learning and Performance of Glidescope® Videolaryngoscope Intubation in Anesthesiologists Trained in Direct Laryngoscopy: a "in Vivo" Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia Intubation Complication
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
First posted: 2013-02-13
Enrollment: 600
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: elective neurosurgical patients from a tertiary neurosurgical centre

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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* any patient undergoing GA

Exclusion Criteria:

* patients with predicted difficult intubation undergoing awake intubation

Primary outcomes:
measure: number of attempts with Glidescope laryngoscopy necessary for beeing considered proficient
timeFrame: from induction of GA to successful intubation
Secondary outcomes:
measure: Features useful to define a Glidescope intubation successful
timeFrame: successfull intubation
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Neurologico Besta
city: Milano
country: Italy
facility: Istituto Neurologico Besta
city: Milan
country: Italy
facility: Istituto Neurologico Besta
Study officials:
affiliation: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
name: Paolo Cortellazzi, MD
role: PRINCIPAL_INVESTIGATOR
References: