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Completed

NCT Number: NCT05429112

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

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 .

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Key information

Conditions

Intubation; Difficult or Failed

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinical Hospital of Santiago de Compostela

Santiago de Compostela, A Coruña, 15866, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flexible Tip Bougie

Device

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

Endotracheal Tube with Stylet

Device

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

Primary outcomes

  1. Difference in the first attempt success rate (percentage)

    Time frame: during intubation

    To compare the difference in the first attempt success rate (percentage) of different techniques for tracheal intubation.

Secondary outcomes

  1. Difference in the overall success rate (percentage)

    Time frame: during intubation

    To compare the difference overall success rate (percentage) of different techniques for tracheal intubation.

  2. Difference in the incidence of complications related to intubation

    Time frame: Participants will be followed from the beginning of the intervention to 30 minutes after the intervention

    To compare the difference in complications (percentage) of different techniques for tracheal intubation:

    Hypoxemia (SpO2) < 90 %, Hypoxemia severe (SpO2) < 80 %, Hypotension defined as systolic blood pressure less than 80 mm Hg, Severe hypotension defined as systolic blood pressure less than 65 mm Hg, Cardiac arrest, death during intubation, Moderate or difficult intubation, oesophageal intubation, pulmonary aspiration, dental injuries.

  3. Difficulty of intubation

    Time frame: during intubation

    Operator-assessed subjective difficulty of intubation by means of a special analogue numerical scale from 0 to 10, where 0=no subjective difficulty and 10=maximal subjective difficulty

  4. Modified Cormack-Lehane grade of glottic view

    Time frame: during intubation

    Modified Cormack-Lehane grade of glottic view:

    I: full view of the glottis IIa: partial view of the glottis IIb: arytenoid or posterior part of the vocal cords just visible III: only epiglottis visible IV: neither glottis nor epiglottis visible

  5. Additional airway equipment

    Time frame: during intubation

    Need for additional airway equipment

  6. Number of intubation attempts

    Time frame: during intubation

    Number of intubation attempts

Sponsors and collaborators

Lead sponsor

Hospital Clinico Universitario de Santiago

Other

Registry information

Official study title

A Randomized Comparison Between the Flexible Tip Bougie Vs Tube with Stylet for First-attempt Intubation Success with a Videolaryngoscopy in ICU Patients

Acronym: VIFLEXTIPICU

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 23, 2022
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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