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Completed

NCT Number: NCT04252222

The VL3 Videolaryngoscope for Elective Tracheal Intubation in Adults

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.

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Key information

Conditions

Difficult Airway Intubation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Università Campus Biomedico

Roma, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Videolaryngoscopy with VL3

Device

Tracheal Intubation aided by VL3 Videolaryngoscope

Primary outcomes

  1. Tracheal intubation rate

    Time frame: 30 minutes

    successful tracheal intubation rate using VL3 video laryngoscope

  2. Number of attempts

    Time frame: 30 minutes

    Number of attempts for a successful tracheal intubation

  3. Total time of intubation

    Time frame: 15 minutes

    Time needed to perform a tracheal intubation from the insertion of VL3 video laryngoscope into the patient mouth

  4. Time to glottis visualization

    Time frame: 15 minutes

    Time needed to visualize the glottis from the insertion of VL3 video laryngoscope into the patient mouth

  5. Cormack-Lehane grade

    Time frame: 15 minutes

    Cormack-Lehane grade observed at videolaryngoscopy

Secondary outcomes

  1. Need for external laryngeal pressure

    Time frame: 15 minutes

    Need for external laryngeal pressure during laryngoscopy

  2. Presence of post-laryngoscopy side effects

    Time frame: 3 days

    Presence of post-laryngoscopy side effects (bleeding, postoperative sore throat and/or dysphonia)

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2020
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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