GlideScope® vs GlideScope® + aScope® for Managing Difficult Airways.

NCT02627755 | Unknown

• 1 other identifier: ROV-GLI-2015-02
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Morbidity; Anesthesia Intubation Complication

Keywords

videolaryngoscopy; difficult airway management

Outcome Measures

Primary Outcomes (1)

• first attempt intubation success rate

  first attempt intubation success rate

  through study completion, an average of 1 year.

Secondary Outcomes (3)

• overall intubation success rate

  through study completion, an average of 1 year.

• intubation time (in seconds)

  through study completion, an average of 1 year

• complications related to intubation

  30 days postoperative

Study Arms (2)

Glide group

ACTIVE COMPARATOR

Device: Glidescope® use

Device: Glidescope®

Glide+aScope group

EXPERIMENTAL

Device: combined use of two airway devices Glidescope® + aScope®

Device: aScope®; Device: Glidescope®

Interventions

aScope® DEVICE

we use the aScope® as a flexible and dirigible guide to facilitate the passage of the endotracheal tube through the vocal cords.

Glide+aScope group

Glidescope® DEVICE

use of Glidescope® in conventional manner to facilitate endotracheal intubation

Glide group; Glide+aScope group

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Manises: lead
• Instituto de Investigacion Sanitaria La Fe: collaborator

Study Sites (1)

Hospital de Manises

Manises, Valencia, 46940, Spain

Location

Related Publications (7)

• 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.

  PMID: 22042705 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

• 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.

  PMID: 20887406 BACKGROUND

• 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.

  PMID: 21354999 BACKGROUND

• 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.

  PMID: 9602574 BACKGROUND

• 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.

  PMID: 31094803 DERIVED

• 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.

  PMID: 31094798 DERIVED

Study Officials

• Lucas Rovira Soriano, PhD MD

  Hospital de Manises

  STUDY CHAIR

• Guido Mazzinari, PhD MD

  Hospital de Manises

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 11, 2015
• Study Start: November 21, 2016
• Primary Completion: October 1, 2017
• Study Completion: November 21, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

ES (1)