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

Not Applicable

• Conditions: Airway Morbidity; Anesthesia Intubation Complication
• Interventions: Device: aScope®; Device: Glidescope®

• Registration Number: NCT02627755
• Lead Sponsor: Hospital de Manises

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).

Study Timeline

• Study First Submitted: 2015-11-30
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-11
• Study Start: 2016-11-21
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-23
• Primary Completion: 2017-10
• Study Completion: 2017-11-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glide+aScope group	aScope®	Device: combined use of two airway devices Glidescope® + aScope®
Glide group	Glidescope®	Device: Glidescope® use
Glide+aScope group	Glidescope®	Device: combined use of two airway devices Glidescope® + aScope®

Primary Outcome Measures

Name	Time	Method
first attempt intubation success rate	through study completion, an average of 1 year.	first attempt intubation success rate

Secondary Outcome Measures

Name	Time	Method
overall intubation success rate	through study completion, an average of 1 year.	through study completion, an average of 1 year.
intubation time (in seconds)	through study completion, an average of 1 year	during anesthetic induction time until inflate pneumo tamponade after tracheal intubation
complications related to intubation	30 days postoperative	questionnaire

Trial Locations

Locations (1)

Hospital de Manises; 🇪🇸 Manises, Valencia, Spain