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

NCT05721690 | Completed DMC

• 1 other identifier: PAR 72.22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation; Difficult or Failed

Outcome Measures

Primary Outcomes (5)

• Tracheal intubation rate

  Successful tracheal intubation rate

  30 minutes

• Number of attempts

  Number of attempts for a successful tracheal intubation

  30 minutes

• Total time of intubation

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

  15 minutes

• Cormack-Lehane grade

  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 Outcomes (4)

• Rate of External laryngeal pressure

  15 minutes

• Rate of of post-laryngoscopy side effects

  24 hours

• Rate of Desaturation

  15 minutes

• Satisfaction Scale

  30 minutes

Study Arms (2)

UED-A

EXPERIMENTAL

Tracheal Intubation with UED-A videolaryngoscope

Device: UED-A Videolaryngoscopy

GLIDESCOPE

ACTIVE COMPARATOR

Tracheal Intubation with Glidescope Titanium videolaryngoscope

Device: Glidescope Videolaryngoscopy

Interventions

UED-A Videolaryngoscopy DEVICE

Tracheal Intubation with UED-A videolaryngoscope

UED-A

Glidescope Videolaryngoscopy DEVICE

Tracheal Intubation with Glidescope Titanium videolaryngoscope

GLIDESCOPE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients candidates for general anesthesia in elective general surgery
• Age over 18 years
• American Society of Anesthesiologists (ASA) physical status I-III.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Campus Bio-medico University Hospital Foundation

Rome, Italy

Location

Related Publications (8)

• Agro FE, Doyle DJ, Vennari M. Use of GlideScope(R) in adults: an overview. Minerva Anestesiol. 2015 Mar;81(3):342-51. Epub 2014 May 27.

  PMID: 24861718 BACKGROUND

• Law JA, Duggan LV, Asselin M, Baker P, Crosby E, Downey A, Hung OR, Kovacs G, Lemay F, Noppens R, Parotto M, Preston R, Sowers N, Sparrow K, Turkstra TP, Wong DT, Jones PM; Canadian Airway Focus Group. Canadian Airway Focus Group updated consensus-based recommendations for management of the difficult airway: part 2. Planning and implementing safe management of the patient with an anticipated difficult airway. Can J Anaesth. 2021 Sep;68(9):1405-1436. doi: 10.1007/s12630-021-02008-z. Epub 2021 Jun 8.

  PMID: 34105065 BACKGROUND

• Aziz MF, Healy D, Kheterpal S, Fu RF, Dillman D, Brambrink AM. Routine clinical practice effectiveness of the Glidescope in difficult airway management: an analysis of 2,004 Glidescope intubations, complications, and failures from two institutions. Anesthesiology. 2011 Jan;114(1):34-41. doi: 10.1097/ALN.0b013e3182023eb7.

  PMID: 21150569 BACKGROUND

• Aziz MF, Bayman EO, Van Tienderen MM, Todd MM; StAGE Investigator Group; Brambrink AM. Predictors of difficult videolaryngoscopy with GlideScope(R) or C-MAC(R) with D-blade: secondary analysis from a large comparative videolaryngoscopy trial. Br J Anaesth. 2016 Jul;117(1):118-23. doi: 10.1093/bja/aew128.

  PMID: 27317711 BACKGROUND

• Al-Ghamdi AA, El Tahan MR, Khidr AM. Comparison of the Macintosh, GlideScope(R), Airtraq(R), and King Vision laryngoscopes in routine airway management. Minerva Anestesiol. 2016 Dec;82(12):1278-1287. Epub 2016 Apr 22.

  PMID: 27103030 BACKGROUND

• Brozek T, Bruthans J, Porizka M, Blaha J, Ulrichova J, Michalek P. A Randomized Comparison of Non-Channeled GlidescopeTM Titanium Versus Channeled KingVisionTM Videolaryngoscope for Orotracheal Intubation in Obese Patients with BMI > 35 kg.m-2. Diagnostics (Basel). 2020 Nov 29;10(12):1024. doi: 10.3390/diagnostics10121024.

  PMID: 33260374 BACKGROUND

• Turkstra TP, Turkstra DC, Pavlosky AW, Jones PM. Simultaneous en bloc endotracheal tube insertion with GlideScope(R) Titanium video laryngoscope use: a randomized-controlled trial. Can J Anaesth. 2020 Nov;67(11):1515-1523. doi: 10.1007/s12630-020-01778-2. Epub 2020 Aug 19.

  PMID: 32815101 BACKGROUND

• Migliorelli S, Strumia A, Costa F, Puricelli G, Ruggiero A, Schiavoni L, Mattei A, Carassiti M, Cataldo R, Agro FE, Pascarella G. Hyper-angulated (Glidescope) versus intermediate-angled (UED-A) videolaryngoscopy for routine tracheal intubation in adults: a prospective randomized controlled trial. Sci Rep. 2026 Jan 14;16(1):1986. doi: 10.1038/s41598-025-30932-3.

  PMID: 41535320 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 10, 2023
• Study Start: February 1, 2023
• Primary Completion: May 12, 2023
• Study Completion: May 13, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)