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

February 22, 2017 updated by: Hospital de Manises

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Hospital de Manises

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
first attempt intubation success rate
Time Frame: through study completion, an average of 1 year.
first attempt intubation success rate
through study completion, an average of 1 year.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Manises

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

November 21, 2017

Study Registration Dates

First Submitted

November 30, 2015

First Submitted That Met QC Criteria

December 9, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ROV-GLI-2015-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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