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

Sponsor
Campus Bio-Medico University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05721690
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
4.9
Anticipated Duration (Months)
12.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: UED-A Videolaryngoscopy
  • Device: Glidescope Videolaryngoscopy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
UED-A Videolaryngoscope vs. Glidescope Titanium for Elective Tracheal Intubation: a Randomized Clinical Trial
Actual Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Tracheal intubation rate [30 minutes]

    Successful tracheal intubation rate

  2. Number of attempts [30 minutes]

    Number of attempts for a successful tracheal intubation

  3. Total time of intubation [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 [15 minutes]

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

  5. Cormack-Lehane grade [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 Outcome Measures

  1. Rate of External laryngeal pressure [15 minutes]

    Rate of external laryngeal pressure during laryngoscopy

  2. Rate of of post-laryngoscopy side effects [24 hours]

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

  3. Rate of Desaturation [15 minutes]

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

  4. Satisfaction Scale [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Patients candidates for general anesthesia in elective 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Campus Bio-medico University Hospital Foundation Rome Italy

Sponsors and Collaborators

  • Campus Bio-Medico University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Giuseppe Pascarella, Principal Investigator, Campus Bio-Medico University
ClinicalTrials.gov Identifier:
NCT05721690
Other Study ID Numbers:
  • PAR 72.22
First Posted:
Feb 10, 2023
Last Update Posted:
Feb 14, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 14, 2023