The VL3 Videolaryngoscope for Elective Tracheal Intubation in Adults

Difficult Airway Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04252222
• Other study ID #: 82/18 OSS ComET CBM
• Status: Completed
• Phase: N/A
• Start date: December 4, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: January 2020
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Difficult Airway Intubation

Intervention

Device:
• Videolaryngoscopy with VL3
Tracheal Intubation aided by VL3 Videolaryngoscope

Locations

Country	Name	City	State
Italy	Università Campus Biomedico	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tracheal intubation rate	successful tracheal intubation rate using VL3 video laryngoscope	30 minutes
Primary	Number of attempts	Number of attempts for a successful tracheal intubation	30 minutes
Primary	Total time of intubation	Time needed to perform a tracheal intubation from the insertion of VL3 video laryngoscope into the patient mouth	15 minutes
Primary	Time to glottis visualization	Time needed to visualize the glottis from the insertion of VL3 video laryngoscope into the patient mouth	15 minutes
Primary	Cormack-Lehane grade	Cormack-Lehane grade observed at videolaryngoscopy	15 minutes
Secondary	Need for external laryngeal pressure	Need for external laryngeal pressure during laryngoscopy	15 minutes
Secondary	Presence of post-laryngoscopy side effects	Presence of post-laryngoscopy side effects (bleeding, postoperative sore throat and/or dysphonia)	3 days