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Flexible Tip Bougie vs Tube With Stylet for Intubation With Videolaryngoscopy.

NCT ID: NCT05429125

Last Updated: 2024-12-31

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-17

Study Completion Date

2025-12-31

Brief Summary

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Although VLs improve glottic visualization, on many occasions it may not be accompanied by intubation at the first attempt, because the endotracheal tube has to pass a sharp angle to enter the trachea. To avoid this limitation, a new flexible tip bougie is designed to flexibly navigate the distal tip and help facilitate precise insertion of the endotracheal tube in the trachea. The flexible tip bougie has an integrated slider along the surface which moves the tip anterior and posterior while the pre-curved distal portion of shaft allows the angulation to provide anterior flexion. This new flexible tip bougie could be used as a rescue when first intubation failure using the videolaryngoscopy, or as a first option to improve the percentage of patients intubated at the first attempt.

Detailed Description

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The purpose of this prospective randomized study is to compare successful intubation on the first attempt with the new flexible tip bougie versus endotracheal tube with stylet during awake intubation with videolaryngoscopy in patients with anticipated difficult airway.

Conditions

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Intubation; Difficult or Failed

Keywords

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intubation difficult airway videolaryngoscope operating room Awake intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Endotracheal Tube with Stylet

Patients randomised to Endotracheal Tube with Stylet will be intubated with a Videolaryngoscopy and with an endotracheal tube + stylet.

Group Type ACTIVE_COMPARATOR

Endotracheal Tube with Stylet

Intervention Type DEVICE

Patients randomised to Endotracheal Tube with Stylet will be intubated with a Videolaryngoscopy and with an endotracheal tube + stylet.

Flexible Tip Bougie

Patients randomised to Flexible Tip Bougie will be intubated with a Videolaryngoscopy and with a Flexible Tip Bougie.

Group Type ACTIVE_COMPARATOR

Flexible Tip Bougie

Intervention Type DEVICE

Patients randomised to Flexible Tip Bougie will be intubated with a Videolaryngoscopy and with a Flexible Tip Bougie.

Interventions

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Endotracheal Tube with Stylet

Patients randomised to Endotracheal Tube with Stylet will be intubated with a Videolaryngoscopy and with an endotracheal tube + stylet.

Intervention Type DEVICE

Flexible Tip Bougie

Patients randomised to Flexible Tip Bougie will be intubated with a Videolaryngoscopy and with a Flexible Tip Bougie.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years and older
* Patients with anticipated difficult airway requiring intubation under with a videolaryngoscopy
* Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.

Exclusion Criteria

* Pregnancy
* age \<18 years
* refusal of the patient
* patient's respiratory failure
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinico Universitario de Santiago

OTHER

Sponsor Role lead

Responsible Party

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Manuel Taboada Muñiz

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manuel Taboada Muñiz, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Clinical Hospital of Santiago de Compostela

Locations

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University Clinical Hospital of Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Manuel Taboada Muñiz, Ph.D.

Role: CONTACT

Phone: 0034-981950674

Email: [email protected]

Manuel Taboada Muñiz, Ph.D.

Role: CONTACT

Phone: 678195618

Email: [email protected]

Facility Contacts

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Manuel Taboada Muñiz, Ph.D.

Role: primary

María Teresa Cabaleiro Ocampo

Role: backup

References

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Ruetzler K, Smereka J, Abelairas-Gomez C, Frass M, Dabrowski M, Bialka S, Misiolek H, Plusa T, Robak O, Aniolek O, Ladny JR, Gorczyca D, Ahuja S, Szarpak L. Comparison of the new flexible tip bougie catheter and standard bougie stylet for tracheal intubation by anesthesiologists in different difficult airway scenarios: a randomized crossover trial. BMC Anesthesiol. 2020 Apr 20;20(1):90. doi: 10.1186/s12871-020-01009-7.

Reference Type BACKGROUND
PMID: 32312225 (View on PubMed)

Driver BE, Prekker ME, Klein LR, Reardon RF, Miner JR, Fagerstrom ET, Cleghorn MR, McGill JW, Cole JB. Effect of Use of a Bougie vs Endotracheal Tube and Stylet on First-Attempt Intubation Success Among Patients With Difficult Airways Undergoing Emergency Intubation: A Randomized Clinical Trial. JAMA. 2018 Jun 5;319(21):2179-2189. doi: 10.1001/jama.2018.6496.

Reference Type BACKGROUND
PMID: 29800096 (View on PubMed)

Other Identifiers

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VIDEOLAR-FLEXTIP-OR

Identifier Type: -

Identifier Source: org_study_id