Flexible Tip Bougie Vs Tube with Stylet for Intubation with a Videolaryngoscopy in ICU (VIDEOL-FLEXTIP) (VIFLEXTIPICU)

Hospital Clinico Universitario de Santiago

Status: Completed

Conditions: Intubation; Difficult or Failed

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05429112

VIDEOLAR-FLEXTIP-ICU

Details and patient eligibility

About

Tracheal intubation in the intensive care unit (ICU) is associated with high incidence of difficult intubation and complications . Videolaryngoscopes (VLs) devices have been proposed to improve airway management, and the use of VLs are recommended as first-line or after a first-attempt failure using direct laryngoscopy in ICU airway management algorithms. Although two meta-analysis showed that videolaryngoscopy improves visualization of the glottis and the first-attempt success, other two meta-analysis reported that videolaryngoscopy didn´t improve first-attempt success rate. The reason may be that 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 .

Full description

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.

The purpose of this prospective randomized study is to compare successful intubation on the first attempt wuth the new flexible tip bougie versus endotracheal tube with stylet during intubation with videolaryngoscopy of critically ill adults in ICU.

Enrollment: 140 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients admitted in the intensive care unit (ICU) and require mechanical ventilation through a tracheal tube.
• Adult (age ≥ 18 years)
• 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

• Refusal of study participation or to pursue the study by the patient
• Pregnancy

Trial design

Primary purpose: Supportive Care

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 a 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