RecruitingNot ApplicableNCT05429125

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

A Randomized Comparison Between the Flexible Tip Bougie vs Tube With Stylet for First-attempt Intubation Success With the C-MAC Videolaryngoscopy in Patients With Anticipated Difficult Airway


Sponsor

Hospital Clinico Universitario de Santiago

Enrollment

140 participants

Start Date

Jun 17, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria3

  • 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 Criteria4

  • Pregnancy
  • age \<18 years
  • refusal of the patient
  • patient's respiratory failure

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Interventions

DEVICEEndotracheal Tube with Stylet

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

DEVICEFlexible Tip Bougie

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


Locations(1)

University Clinical Hospital of Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

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NCT05429125


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