Clinical trial NCT02627755: GlideScope® vs GlideScope® + aScope® for Managing Difficult Airways.
Official title: GlideScope® vs GlideScope® + aScope® for Managing Difficult Airways. Assessment of a New Procedure for Endotracheal Intubation in Patients With Suspected Difficult Airways
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Airway Morbidity
Anesthesia Intubation Complication
Keywords: videolaryngoscopy
difficult airway management
Lead sponsor: Hospital de Manises
Sponsor class: OTHER
Collaborators: name: Instituto de Investigacion Sanitaria La Fe
First posted: 2015-12-11
Enrollment: 160
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 use in a combined way of two systems of intubation (Glidescope + aScope) would condition an increase in the success rate of endotracheal intubation maneuver compared to conventional isolated Glidescope use in patients with clinical criteria of difficult airway.

Detailed description: Worldwide, up to 600 patients are estimated to die annually as a result of the complications that occur during tracheal intubation The GlideScope® (videolaryngoscope) is used for endotracheal intubation in patients with difficult airway predictors, in this patients overall success intubation rate is 96%. but success intubation rate at first attempt is only 86%.

Despite this positive rates, due to high comorbidity when intubation fails, both failure rates (inverse of success rate) are impermissible. 14% failure at the first attempt intubation as well as 4% overall intubation failure.

in this study the investigators try to show that new procedure associating aScope® (disposable fiberscope) together with GlideScope® increases the success intubation rate of both ( overall and first attempt).

Eligibility criteria: Inclusion Criteria:

* Patients programed for general anesthesia with endotracheal intubation required that presents one or both criteria of difficult airway predictors:
* criteria 1: Arne test \>10 (Arne J,1998)
* criteria 2: Ratio between neck circumference and thyromental distance \> 4. (Kim WH, 2011)

Exclusion Criteria:

* Patients with mouth opening which does not allow the introduction of video laryngoscope.
* Patients with indication of flexible fiberoptic intubation with awake patient.

Primary outcomes:
measure: first attempt intubation success rate
timeFrame: through study completion, an average of 1 year.
Secondary outcomes:
measure: overall intubation success rate
timeFrame: through study completion, an average of 1 year.
measure: intubation time (in seconds)
timeFrame: through study completion, an average of 1 year
measure: complications related to intubation
timeFrame: 30 days postoperative
Other outcomes:
Locations:
city: Manises
country: Spain
facility: Hospital de Manises
state: Valencia
Study officials:
affiliation: Hospital de Manises
name: Lucas Rovira Soriano, PhD MD
role: STUDY_CHAIR
affiliation: Hospital de Manises
name: Guido Mazzinari, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Griesdale DE, Liu D, McKinney J, Choi PT. Glidescope(R) video-laryngoscopy versus direct laryngoscopy for endotracheal intubation: a systematic review and meta-analysis. Can J Anaesth. 2012 Jan;59(1):41-52. doi: 10.1007/s12630-011-9620-5. Epub 2011 Nov 1.
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: Niforopoulou P, Pantazopoulos I, Demestiha T, Koudouna E, Xanthos T. Video-laryngoscopes in the adult airway management: a topical review of the literature. Acta Anaesthesiol Scand. 2010 Oct;54(9):1050-61. doi: 10.1111/j.1399-6576.2010.02285.x. Epub 2010 Jul 28.
citation: Kim WH, Ahn HJ, Lee CJ, Shin BS, Ko JS, Choi SJ, Ryu SA. Neck circumference to thyromental distance ratio: a new predictor of difficult intubation in obese patients. Br J Anaesth. 2011 May;106(5):743-8. doi: 10.1093/bja/aer024. Epub 2011 Feb 24.
citation: Arne J, Descoins P, Fusciardi J, Ingrand P, Ferrier B, Boudigues D, Aries J. Preoperative assessment for difficult intubation in general and ENT surgery: predictive value of a clinical multivariate risk index. Br J Anaesth. 1998 Feb;80(2):140-6. doi: 10.1093/bja/80.2.140.
citation: Guay J, Williams SR, Robin F, Ruel M. Effect of Intravenous Dexamethasone on the Regression of Isobaric Bupivacaine Spinal Anesthesia: A Randomized Controlled Trial. Anesth Analg. 2019 Jun;128(6):e100-e103. doi: 10.1213/ANE.0000000000003670.
citation: Mazzinari G, Rovira L, Henao L, Ortega J, Casasempere A, Fernandez Y, Acosta M, Belaouchi M, Esparza-Minana JM. Effect of Dynamic Versus Stylet-Guided Intubation on First-Attempt Success in Difficult Airways Undergoing Glidescope Laryngoscopy: A Randomized Controlled Trial. Anesth Analg. 2019 Jun;128(6):1264-1271. doi: 10.1213/ANE.0000000000004102.