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Trial record 3 of 4 for:    9602574 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT02627755
Recruitment Status : Active, not recruiting
First Posted : December 11, 2015
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
Instituto de Investigacion Sanitaria La Fe
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Airway Morbidity Anesthesia Intubation Complication Device: aScope® Device: Glidescope® Not Applicable

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  (Clinical Trial)
Estimated 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 : November 21, 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : November 21, 2017

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




Primary Outcome Measures :
  1. first attempt intubation success rate [ Time Frame: through study completion, an average of 1 year. ]
    first attempt intubation success rate


Secondary Outcome Measures :
  1. overall intubation success rate [ Time Frame: through study completion, an average of 1 year. ]
    through study completion, an average of 1 year.

  2. 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

  3. complications related to intubation [ Time Frame: 30 days postoperative ]
    questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02627755


Locations
Spain
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

Publications:
Responsible Party: Hospital de Manises
ClinicalTrials.gov Identifier: NCT02627755     History of Changes
Other Study ID Numbers: ROV-GLI-2015-02
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 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:
videolaryngoscopy
difficult airway management