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

August 29, 2023 updated by: Giuseppe Pascarella, Campus Bio-Medico University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy
        • Campus Bio-medico University Hospital Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UED-A
Tracheal Intubation with UED-A videolaryngoscope
Device: UED-A Videolaryngoscopy
Tracheal Intubation with UED-A videolaryngoscope
Active Comparator: GLIDESCOPE
Tracheal Intubation with Glidescope Titanium videolaryngoscope
Device: Glidescope Videolaryngoscopy
Tracheal Intubation with Glidescope Titanium videolaryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of attempts
Time Frame: 30 minutes
Number of attempts for a successful tracheal intubation
30 minutes
Tracheal intubation rate
Time Frame: 30 minutes
Successful tracheal intubation rate
30 minutes
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
15 minutes
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
15 minutes
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
15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
30 minutes
Rate of External laryngeal pressure
Time Frame: 15 minutes
Rate of external laryngeal pressure during laryngoscopy
15 minutes
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)
24 hours
Rate of Desaturation
Time Frame: 15 minutes
Rate of Desaturation (spO2 < 93%) during tracheal intubation attempts
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Campus Bio-Medico University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

May 12, 2023

Study Completion (Actual)

May 13, 2023

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • PAR 72.22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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