Clinical trial NCT02897518: Videolaryngoscopes for Tracheal Intubation
Official title: Comparison Between Imago V-Blade and Glidescope During Endotracheal Intubation: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Management
Keywords: Videolaryngoscopes
Intubation
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary end point of this study is the feasibility of intubation. The secondary end-points are the success to intubate in the first attempt, the intubation time, the Cormack and Lehane score view, the comparison of the intubation difficulty scale (IDS) score and the need for maneuvers to aid the endotracheal intubation comparing Imago V-Blade ® and Glidescope®.

Patients admit to the operation rooms of University of Naples "Federico II" and requiring endotracheal intubation for general anesthesia will be consecutively screened for the presence of predicted difficult airway according Italian guideline. According to this guideline, the presence of one or more of the following parameters may be considered highly predictive of difficult intubation: Mallampati class 3-4, inter-incisor distance \< 30 mm, mental-thyroidal distance \< 60 mm, large prominence of superior incisors above inferior incisors uncorrectable with jaw-thrust, reduced head and neck motility, and reduced mental-jugular distance. Patients matching more then 1 of the previous criteria stated by Italian guideline will be included in this case controlled study. Patients 1) without criteria for predicted difficult airway; 2) those requiring emergency surgery; 3) aged \< 18 years; or 4) declined consent to participate, will be excluded from this study.The primary end-point was the comparison of the intubation difficulty scale (IDS) score. The secondary end-points were the learning curve, the intubation time, the Cormack and Lehane score view, and the need for maneuvers to aid the endotracheal intubation comparing different videolaryngoscopes available in our department. Two anesthesiologists with 10 years of experience in conventional endotracheal intubation and trained for video assisted intubation will perform the maneuvers.


Eligibility criteria: Inclusion Criteria:

* Age\>18 years
* Mallampati class 3-4
* inter-incisor distance \< 30 mm
* mental-thyroidal distance \< 60 mm
* large prominence of superior incisors above inferior incisors uncorrectable with jaw-thrust -reduced head and neck motility
* reduced mental-jugular distance.

Exclusion Criteria:

* \< 1 criteria for predicted difficult airway
* emergency surgery
* age \< 18 years
* declined consent to participate

Primary outcomes:
measure: feasibility of endotracheal intubation
timeFrame: within 60 seconds
Secondary outcomes:
measure: Success rate of endotracheal intubation using Imago V-Blade compared with Glidescope
timeFrame: wthin 120 seconds
measure: Intubation time
timeFrame: wthin 120 seconds
measure: Cormack and Lehane score view
timeFrame: During endotracheal intubation
measure: use of adjunctive maneuvers to aid the endotracheal intubation
timeFrame: During endotracheal intubation
measure: Intubation difficulty scale score
timeFrame: within 60 seconds
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples Federico II department of Anesthesia and Critical Care
Study officials:
References:
citation: Vargas M, Pastore A, Aloj F, Laffey JG, Servillo G. A comparison of videolaryngoscopes for tracheal intubation in predicted difficult airway: a feasibility study. BMC Anesthesiol. 2017 Feb 20;17(1):25. doi: 10.1186/s12871-017-0318-2.