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

Sponsor
Hospital de Manises (Other)
Overall Status
Unknown status
CT.gov ID
NCT02627755
Collaborator
Instituto de Investigacion Sanitaria La Fe (Other)
160
1
2
12
13.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: aScope®
  • Device: Glidescope®
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
GlideScope® vs GlideScope® + aScope® for Managing Difficult Airways. Assessment of a New Procedure for Endotracheal Intubation in Patients With Suspected Difficult Airways
Actual Study Start Date :
Nov 21, 2016
Anticipated Primary Completion Date :
Oct 1, 2017
Anticipated Study Completion Date :
Nov 21, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Glide group

Device: Glidescope® use

Device: Glidescope®
use of Glidescope® in conventional manner to facilitate endotracheal intubation

Experimental: Glide+aScope group

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

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

Device: Glidescope®
use of Glidescope® in conventional manner to facilitate endotracheal intubation

Outcome Measures

Primary Outcome Measures

  1. first attempt intubation success rate [through study completion, an average of 1 year.]

    first attempt intubation success rate

Secondary Outcome Measures

  1. overall intubation success rate [through study completion, an average of 1 year.]

    through study completion, an average of 1 year.

  2. intubation time (in seconds) [through study completion, an average of 1 year]

    during anesthetic induction time until inflate pneumo tamponade after tracheal intubation

  3. complications related to intubation [30 days postoperative]

    questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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,

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital de Manises Manises Valencia Spain 46940

Sponsors and Collaborators

  • Hospital de Manises
  • Instituto de Investigacion Sanitaria La Fe

Investigators

  • Study Chair: Lucas Rovira Soriano, PhD MD, Hospital de Manises
  • Principal Investigator: Guido Mazzinari, PhD MD, Hospital de Manises

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hospital de Manises
ClinicalTrials.gov Identifier:
NCT02627755
Other Study ID Numbers:
  • ROV-GLI-2015-02
First Posted:
Dec 11, 2015
Last Update Posted:
Feb 23, 2017
Last Verified:
Feb 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospital de Manises

Study Results

No Results Posted as of Feb 23, 2017