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OpenTrials
Completed

NCT Number: NCT05721690

UED-A Videolaryngoscope vs. Glidescope Titanium for Elective Tracheal Intubation

The present randomized clinical trial wants to compare the efficacy and safety of UED-A videolaryngoscope to Glidescope Titanium for routinely tracheal intubation in 60 adults, in terms of successful rate, no. attempts and manoeuvre duration.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campus Bio-medico University Hospital Foundation

Rome, 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 general surgery
  • Age over 18 years
  • American Society of Anesthesiologists (ASA) physical status I-III.

Exclusion criteria

  • Refusal to sign informed consent
  • Paediatric population
  • ASA physical status IV
  • Emergency tracheal intubation
  • Independent Predictors of difficult Videolaryngoscopy (Neck extension < 80°, macroglossia, interincisor distance < 3 cm, anatomical alterations of the neck, cardiac surgery, ear-nose-throat surgery)

Treatment and study plan

UED-A Videolaryngoscopy

Device

Tracheal Intubation with UED-A videolaryngoscope

Glidescope Videolaryngoscopy

Device

Tracheal Intubation with Glidescope Titanium videolaryngoscope

Primary outcomes

  1. Tracheal intubation rate

    Time frame: 30 minutes

    Successful tracheal intubation rate

  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 the 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 the video laryngoscope into the patient mouth

  5. Cormack-Lehane grade

    Time frame: 15 minutes

    Cormack-Lehane grade observed at videolaryngoscopy Grade 1: Full view of glottis Grade 2: Partial view of glottis Grade 3: Only epiglottis seen, none of glottis seen Grade 4: Neither glottis nor epiglottis seen

Secondary outcomes

  1. Rate of External laryngeal pressure

    Time frame: 15 minutes

    Rate of external laryngeal pressure during laryngoscopy

  2. Rate of of post-laryngoscopy side effects

    Time frame: 24 hours

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

  3. Rate of Desaturation

    Time frame: 15 minutes

    Rate of Desaturation (spO2 < 93%) during tracheal intubation attempts

  4. Satisfaction Scale

    Time frame: 30 minutes

    Clinicians Satisfaction with the use of the videolaryngoscope, expressed by a 0-10 numeric rating scale (0 = the worst videolaryngoscopy ever performed; 10 = the best videolaryngoscopy ever performed)

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

UED-A Videolaryngoscope vs. Glidescope Titanium for Elective Tracheal Intubation: a Randomized Clinical Trial

Acronym: UED-VLG

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2023
Registry last updated
Aug 30, 2023

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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