The VL3 Videolaryngoscope for Elective Tracheal Intubation in Adults

The VL3 Videolaryngoscope for Elective Tracheal Intubation in Adults: a Prospective Pilot Study

We conducted an observational prospective pilot study to assess the efficacy of the VL3 videolaryngoscope for routinely tracheal intubation in 56 adults, in terms of successful rate, no. attempts and manoeuvre duration, including both normal and difficult airways.

Study Overview

• Status: Completed
• Conditions: Difficult Airway Intubation
• Intervention / Treatment: Device: Videolaryngoscopy with VL3

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy
    • Università Campus Biomedico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients candidates for general anesthesia in elective surgery
• Age over 18 years
• ASA physical status I-III.

Exclusion Criteria:

• Paediatric population
• ASA physical status IV
• Emergency tracheal intubation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: VL3; Tracheal intubation with VL3 videolaryngoscope	Device: Videolaryngoscopy with VL3; Tracheal Intubation aided by VL3 Videolaryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tracheal intubation rate	successful tracheal intubation rate using VL3 video laryngoscope	30 minutes
Number of attempts	Number of attempts for a successful tracheal intubation	30 minutes
Total time of intubation	Time needed to perform a tracheal intubation from the insertion of VL3 video laryngoscope into the patient mouth	15 minutes
Time to glottis visualization	Time needed to visualize the glottis from the insertion of VL3 video laryngoscope into the patient mouth	15 minutes
Cormack-Lehane grade	Cormack-Lehane grade observed at videolaryngoscopy	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for external laryngeal pressure	Need for external laryngeal pressure during laryngoscopy	15 minutes
Presence of post-laryngoscopy side effects	Presence of post-laryngoscopy side effects (bleeding, postoperative sore throat and/or dysphonia)	3 days

Collaborators and Investigators

• Sponsor: Campus Bio-Medico University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 4, 2018
• Primary Completion (ACTUAL): April 1, 2019
• Study Completion (ACTUAL): April 1, 2019

Study Registration Dates

• First Submitted: January 30, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (ACTUAL): February 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 82/18 OSS ComET CBM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No