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

Study Overview
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Brief Summary
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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 .

Detailed Description
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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.

Official Title
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A Randomized Comparison Between the Flexible Tip Bougie vs Tube With Stylet for First-attempt Intubation Success With a Videolaryngoscopy in ICU Patients

Conditions
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Intubation; Difficult or Failed

Intervention / Treatment
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* Device: Flexible Tip Bougie
* Device: Endotracheal Tube with Stylet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endotracheal Tube with Stylet<br>Patients randomised to Endotracheal Tube with Stylet will be intubated with a Videolaryngoscopy and with a endotracheal tube + stylet. | Device: Endotracheal Tube with Stylet<br>* Patients randomised to Endotracheal Tube with Stylet will be intubated with a Videolaryngoscopy and with a endotracheal tube + stylet.<br>|
| Active Comparator: Flexible Tip Bougie<br>Patients randomised to Flexible Tip Bougie will be intubated with a Videolaryngoscopy and with a Flexible Tip Bougie. | Device: Flexible Tip Bougie<br>* Patients randomised to Flexible Tip Bougie will be intubated with a Videolaryngoscopy and with a Flexible Tip Bougie.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the first attempt success rate (percentage) | To compare the difference in the first attempt success rate (percentage) of different techniques for tracheal intubation. | during intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the overall success rate (percentage) | To compare the difference overall success rate (percentage) of different techniques for tracheal intubation. | during intubation | 
| Difference in the incidence of complications related to intubation | 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. | Participants will be followed from the beginning of the intervention to 30 minutes after the intervention | 
| Difficulty of 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 | during intubation | 
| Modified Cormack-Lehane grade of glottic view | 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 | during intubation | 
| Additional airway equipment | Need for additional airway equipment | during intubation | 
| Number of intubation attempts | Number of intubation attempts | during intubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intubation, difficult airway, videolaryngoscope, Intensive Care Unit, bougie