NCT04252222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

January 30, 2020

Last Update Submit

January 30, 2020

Conditions

Difficult Airway Intubation

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (2)

  • Need for external laryngeal pressure

    15 minutes

  • Presence of post-laryngoscopy side effects

    3 days

Study Arms (1)

VL3

EXPERIMENTAL

Tracheal intubation with VL3 videolaryngoscope

Device: Videolaryngoscopy with VL3

Interventions

Videolaryngoscopy with VL3DEVICE

Tracheal Intubation aided by VL3 Videolaryngoscope

VL3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università Campus Biomedico

Roma, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Unit of Anesthesia and Intensive Care

Study Record Dates

First Submitted

January 30, 2020

First Posted

February 5, 2020

Study Start

December 4, 2018

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

February 5, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)