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Videolaryngoscopes for Tracheal Intubation

Comparison Between Imago V-Blade and Glidescope During Endotracheal Intubation: a Feasibility Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02897518
Enrollment
45
Registered
2016-09-13
Start date
2015-01-31
Completion date
2016-01-31
Last updated
2017-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Management

Keywords

Videolaryngoscopes, Intubation

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.

Interventions

DEVICEImago V-Balde

the endotracheal intubation will be performed with videolaryngoscopes (imago V-Blade) according to the user manual

DEVICEGlidescope

the endotracheal intubation will be performed with videolaryngoscopes (Glidescope) according to the user manual

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 77 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
feasibility of endotracheal intubationwithin 60 seconds

Secondary

MeasureTime frameDescription
Success rate of endotracheal intubation using Imago V-Blade compared with Glidescopewthin 120 secondsTime to reach a successful endotracheal intubation from the beginning of indirect laryngoscopy to the confirmation of the intubation with the evaluation of the end-tidal carbon dioxide
Intubation timewthin 120 secondstime to reach endotracheal intubation from the beginning of indirect laryngoscopy to the confirmation of the intubation with the evaluation of the end-tidal carbon dioxide
Cormack and Lehane score viewDuring endotracheal intubation
use of adjunctive maneuvers to aid the endotracheal intubationDuring endotracheal intubationthe investigators evaluated the necessary maneuvers to aid a successful endotracheal intubation as number of Readjusting patient's head, number of external laryngeal pressure, number of advancement or withdrawal the blade and number of increased lifting force
Intubation difficulty scale scorewithin 60 secondsTime to pass the vocal cord during the successful endotracheal intubation measured from the beginning of indirect laryngoscopy to the confirmation of the intubation with the evaluation of the end-tidal carbon dioxide

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026