Videolaryngoscopes for Tracheal Intubation

Airway Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02897518
• Other study ID #: Airway1
• Status: Completed
• Phase: N/A
• First received: August 25, 2016
• Last updated: January 4, 2017
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2017
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 77 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Airway Management

Intervention

Device:
• Imago V-Balde
the endotracheal intubation will be performed with videolaryngoscopes (imago V-Blade) according to the user manual
• Glidescope
the endotracheal intubation will be performed with videolaryngoscopes (Glidescope) according to the user manual

Locations

Country	Name	City	State
Italy	University of Naples Federico II department of Anesthesia and Critical Care	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of endotracheal intubation		within 60 seconds	Yes
Secondary	Success rate of endotracheal intubation using Imago V-Blade compared with Glidescope	Time 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	wthin 120 seconds	No
Secondary	Intubation time	time 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	wthin 120 seconds	No
Secondary	Cormack and Lehane score view		During endotracheal intubation	No
Secondary	use of adjunctive maneuvers to aid the endotracheal intubation	the 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	During endotracheal intubation	No
Secondary	Intubation difficulty scale score	Time 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	within 60 seconds	No