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

NCT ID: NCT02627755

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-21

Study Completion Date

2017-11-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Airway Morbidity Anesthesia Intubation Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Glide group

Device: Glidescope® use

Group Type ACTIVE_COMPARATOR

Glidescope®

Intervention Type DEVICE

use of Glidescope® in conventional manner to facilitate endotracheal intubation

Glide+aScope group

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

Group Type EXPERIMENTAL

aScope®

Intervention Type DEVICE

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

Glidescope®

Intervention Type DEVICE

use of Glidescope® in conventional manner to facilitate endotracheal intubation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

aScope®

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

Intervention Type DEVICE

Glidescope®

use of Glidescope® in conventional manner to facilitate endotracheal intubation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Instituto de Investigacion Sanitaria La Fe

OTHER

Sponsor Role collaborator

Hospital de Manises

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lucas Rovira Soriano, PhD MD

Role: STUDY_CHAIR

Hospital de Manises

Guido Mazzinari, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Manises

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital de Manises

Manises, Valencia, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

Griesdale DE, Liu D, McKinney J, Choi PT. Glidescope(R) 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. Epub 2011 Nov 1.

Reference Type BACKGROUND
PMID: 22042705 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21150569 (View on PubMed)

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. Epub 2010 Jul 28.

Reference Type BACKGROUND
PMID: 20887406 (View on PubMed)

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. Epub 2011 Feb 24.

Reference Type BACKGROUND
PMID: 21354999 (View on PubMed)

Arne J, Descoins P, Fusciardi J, Ingrand P, Ferrier B, Boudigues D, Aries 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. doi: 10.1093/bja/80.2.140.

Reference Type BACKGROUND
PMID: 9602574 (View on PubMed)

Guay J, Williams SR, Robin F, Ruel M. Effect of Intravenous Dexamethasone on the Regression of Isobaric Bupivacaine Spinal Anesthesia: A Randomized Controlled Trial. Anesth Analg. 2019 Jun;128(6):e100-e103. doi: 10.1213/ANE.0000000000003670.

Reference Type DERIVED
PMID: 31094803 (View on PubMed)

Mazzinari G, Rovira L, Henao L, Ortega J, Casasempere A, Fernandez Y, Acosta M, Belaouchi M, Esparza-Minana JM. Effect of Dynamic Versus Stylet-Guided Intubation on First-Attempt Success in Difficult Airways Undergoing Glidescope Laryngoscopy: A Randomized Controlled Trial. Anesth Analg. 2019 Jun;128(6):1264-1271. doi: 10.1213/ANE.0000000000004102.

Reference Type DERIVED
PMID: 31094798 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ROV-GLI-2015-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.