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

NCT05429112 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2024-10-22

No results posted yet for this study

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 .

Conditions

  • Intubation; Difficult or Failed

Interventions

DEVICE

Flexible Tip Bougie

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

DEVICE

Endotracheal Tube with Stylet

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

Sponsors & Collaborators

  • Hospital Clinico Universitario de Santiago

    lead OTHER

Principal Investigators

  • Manuel Taboada Muñiz, Ph.D. · University Clinical Hospital of Santiago de Compostela

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-17
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05429112 on ClinicalTrials.gov