The VL3 Videolaryngoscope for Elective Tracheal Intubation in Adults

Not Applicable

Completed

• Conditions: Difficult Airway Intubation
• Interventions: Device: Videolaryngoscopy with VL3

• Registration Number: NCT04252222
• Lead Sponsor: Campus Bio-Medico University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-04
• Primary Completion: 2019-04-01
• Study Completion: 2019-04-01
• Status Verified: 2020-01
• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-01-30
• Last Update Submitted: 2020-01-30
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VL3	Videolaryngoscopy with VL3	Tracheal intubation with VL3 videolaryngoscope

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Università Campus Biomedico; 🇮🇹 Roma, Italy