Flexible Tip Bougie vs Tube With Stylet for Intubation With a

Status Recruiting

Clinical Trial Summary

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 .

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Intubation; Difficult or Failed

Clinical Trial Details

NCT number	NCT05429112
Study type	Interventional
Source	Hospital Clinico Universitario de Santiago
Contact	Manuel Taboada Muñiz, Ph.D.
Phone	0034-981950674
Email	manutabo@yahoo.es
Status	Recruiting
Phase	N/A
Start date	May 17, 2022
Completion date	December 31, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Flexible Tip Bougie vs Tube With Stylet for Intubation With a Videolaryngoscopy in ICU (VIDEOL-FLEXTIP) — VIFLEXTIPICU

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms