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

Not Applicable

Completed

• Conditions: Intubation; Difficult or Failed
• Interventions: Device: Glidescope Videolaryngoscopy; Device: UED-A Videolaryngoscopy

• Registration Number: NCT05721690
• Lead Sponsor: Campus Bio-Medico University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-02-01
• Study First Posted: 2023-02-10
• Primary Completion: 2023-05-12
• Study Completion: 2023-05-13
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLIDESCOPE	Glidescope Videolaryngoscopy	Tracheal Intubation with Glidescope Titanium videolaryngoscope
UED-A	UED-A Videolaryngoscopy	Tracheal Intubation with UED-A videolaryngoscope

Primary Outcome Measures

Name	Time	Method
Tracheal intubation rate	30 minutes	Successful tracheal intubation rate
Number of attempts	30 minutes	Number of attempts for a successful tracheal intubation
Time to glottis visualization	15 minutes	Time needed to visualize the glottis from the insertion of the video laryngoscope into the patient mouth
Total time of intubation	15 minutes	Time needed to perform a tracheal intubation from the insertion of the video laryngoscope into the patient mouth
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

Name	Time	Method
Rate of External laryngeal pressure	15 minutes	Rate of external laryngeal pressure during laryngoscopy
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)
Rate of of post-laryngoscopy side effects	24 hours	Rate of of post-laryngoscopy side effects (bleeding, postoperative sore throat and/or dysphonia)
Rate of Desaturation	15 minutes	Rate of Desaturation (spO2 \< 93%) during tracheal intubation attempts

Trial Locations

Locations (1)

Campus Bio-medico University Hospital Foundation; 🇮🇹 Rome, Italy