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

Anesthesia Intubation Complication Clinical Trial

Official title:

GlideScope® vs GlideScope® + aScope® for Managing Difficult Airways. Assessment of a New Procedure for Endotracheal Intubation in Patients With Suspected Difficult Airways

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02627755
• Other study ID #: ROV-GLI-2015-02
• Status: Active, not recruiting
• Phase: N/A
• First received: November 30, 2015
• Last updated: February 22, 2017
• Start date: November 21, 2016
• Est. completion date: November 21, 2017

Study information

• Verified date: February 2017
• Source: Hospital de Manises
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: November 21, 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Airway Morbidity
• Anesthesia Intubation Complication

Intervention

Device:
• aScope®
we use the aScope® as a flexible and dirigible guide to facilitate the passage of the endotracheal tube through the vocal cords.
• Glidescope®
use of Glidescope® in conventional manner to facilitate endotracheal intubation

Locations

Country	Name	City	State
Spain	Hospital de Manises	Manises	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Manises	Instituto de Investigacion Sanitaria La Fe

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Arné J, Descoins P, Fusciardi J, Ingrand P, Ferrier B, Boudigues D, Ariès 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. — 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

Griesdale DE, Liu D, McKinney J, Choi PT. Glidescope® 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	first attempt intubation success rate	first attempt intubation success rate	through study completion, an average of 1 year.
Secondary	overall intubation success rate	through study completion, an average of 1 year.	through study completion, an average of 1 year.
Secondary	intubation time (in seconds)	during anesthetic induction time until inflate pneumo tamponade after tracheal intubation	through study completion, an average of 1 year
Secondary	complications related to intubation	questionnaire	30 days postoperative