Clinical trial NCT05721690: UED-A Videolaryngoscope vs. Glidescope Titanium for Elective Tracheal Intubation
Official title: UED-A Videolaryngoscope vs. Glidescope Titanium for Elective Tracheal Intubation: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult or Failed
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Tracheal intubation rate
timeFrame: 30 minutes
measure: Number of attempts
timeFrame: 30 minutes
measure: Total time of intubation
timeFrame: 15 minutes
measure: Time to glottis visualization
timeFrame: 15 minutes
measure: Cormack-Lehane grade
timeFrame: 15 minutes
Secondary outcomes:
measure: Rate of External laryngeal pressure
timeFrame: 15 minutes
measure: Rate of of post-laryngoscopy side effects
timeFrame: 24 hours
measure: Rate of Desaturation
timeFrame: 15 minutes
measure: Satisfaction Scale
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Campus Bio-medico University Hospital Foundation
Study officials:
References:
citation: 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.
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.
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.
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.
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.
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.
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.