Flexible Tip Bougie vs Tube With Stylet for Intubation With Videolaryngoscopy. (VIFLEXTIPOR)

Hospital Clinico Universitario de Santiago

Status: Enrolling

Conditions: Intubation; Difficult or Failed

Treatments: Device: Flexible Tip Bougie; Device: Endotracheal Tube with Stylet

Study type: Interventional

Funder types: Other

Identifiers

NCT05429125

VIDEOLAR-FLEXTIP-OR

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Endotracheal Tube with Stylet

Active Comparator group

Description:

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

Treatment:

Device: Endotracheal Tube with Stylet

Flexible Tip Bougie

Active Comparator group

Description:

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

Treatment:

Device: Flexible Tip Bougie