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

Intubation; Difficult or Failed Clinical Trial

— UED-VLG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05721690
• Other study ID #: PAR 72.22
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: May 13, 2023

Study information

• Verified date: August 2023
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 13, 2023
• Est. primary completion date: May 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Intubation; Difficult or Failed

Intervention

Device:
• UED-A Videolaryngoscopy
Tracheal Intubation with UED-A videolaryngoscope
• Glidescope Videolaryngoscopy
Tracheal Intubation with Glidescope Titanium videolaryngoscope

Locations

Country	Name	City	State
Italy	Campus Bio-medico University Hospital Foundation	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tracheal intubation rate	Successful tracheal intubation rate	30 minutes
Primary	Number of attempts	Number of attempts for a successful tracheal intubation	30 minutes
Primary	Total time of intubation	Time needed to perform a tracheal intubation from the insertion of the video laryngoscope into the patient mouth	15 minutes
Primary	Time to glottis visualization	Time needed to visualize the glottis from the insertion of the video laryngoscope into the patient mouth	15 minutes
Primary	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	Rate of External laryngeal pressure	Rate of external laryngeal pressure during laryngoscopy	15 minutes
Secondary	Rate of of post-laryngoscopy side effects	Rate of of post-laryngoscopy side effects (bleeding, postoperative sore throat and/or dysphonia)	24 hours
Secondary	Rate of Desaturation	Rate of Desaturation (spO2 < 93%) during tracheal intubation attempts	15 minutes
Secondary	Satisfaction Scale	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