Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID05429125

Comparison of Flexible Tip Bougie Versus Endotracheal Tube with Stylet for First-Attempt Intubation Success Using C-MAC Videolaryngoscopy in Patients with Difficult Airways

Led by Hospital Clinico Universitario de Santiago · Updated on 2024-12-31

140

Participants Needed

1

Research Sites

184 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare two devices used for intubation in patients with anticipated difficult airways. The study focuses on assessing which device achieves a higher success rate on the first attempt during awake intubation using videolaryngoscopy. The trial evaluates the new flexible tip bougie, designed to navigate the airway more precisely, against the traditional endotracheal tube with stylet. Participants will be randomly assigned to one of two groups: one using the flexible tip bougie and the other using the endotracheal tube with stylet. Both groups undergo intubation with videolaryngoscopy. The flexible tip bougie features an integrated slider that allows flexible movement of its tip to facilitate easier insertion, potentially improving first-attempt success rates. Throughout the study, researchers will monitor the first attempt intubation success rate during the procedure. Participants include adults aged 18 to 90 with anticipated difficult airways requiring intubation. Consent will be obtained prior to inclusion. Safety and effectiveness will be carefully observed during and immediately after intubation to determine which device better supports successful airway management.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years and older
  • Patients with anticipated difficult airway requiring intubation with videolaryngoscopy
  • Written informed consent from the patient or proxy before inclusion or when possible in emergency
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Age under 18 years
  • Patient refusal
  • Patient's respiratory failure

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Clinical Hospital of Santiago de Compostela

Santiago de Compostela, A Coruña, Spain, 15866

Actively Recruiting

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Research Team

M

Manuel Taboada Muñiz, Ph.D.

M

Manuel Taboada Muñiz, Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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.

Kurt Ruetzler, Jacek Smereka, Cristian Abelairas-Gomez...

https://pubmed.ncbi.nlm.nih.gov/32312225

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.

Brian E Driver, Matthew E Prekker, Lauren R Klein...

https://pubmed.ncbi.nlm.nih.gov/29800096