C-MAC Videolaryngoscopy Versus Direct Laryngoscopy for Percutaneous Tracheostomy

Study Overview
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Brief Summary
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When preparing an ICU patient for percutaneous dilational tracheostomy, correct positioning of the endotracheal tube is important. During the procedure, it is possible to puncture the cuff. Tracheal tube cuff puncture can lead to failure of ventilation, loss of positive end-expiratory pressure, and possible aspiration of gastric contents blood or secretions. To minimize the risk, in our ICU, we withdraw the endotracheal tube under direct laryngoscopic vision until the cuff is visible at the vocal cords. This maneuver would also facilitate insertion of the Seldinger needle and insertion of the tracheostomy tube below the endotracheal tube. However, this maneuver to remove the endotracheal tube under direct laryngoscopy can sometimes be difficult. ICU patients present frecuently difficult laryngoscopic vision due to airway edema or secretions. In ICU, the videolaryngopy has been shown to be superior to direct laryngoscopy in visualization the upper airway, allowing better laryngoscopic vision.

Detailed Description
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The investigators aim to compare C-MAC videolaryngoscopy versus conventional direct laryngoscopy for positioning the tracheal tube to facilitate insertion of the Seldinger needle and the tracheostomy tube below the endotracheal tube during percutaneous tracheostomy.

Official Title
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Videolaryngoscopy Versus Direct Laryngoscopy for Positioning the Tracheal Tube During Percutaneous Tracheostomy: A Randomized Controlled Trial (VIDLARTRAQUEO).

Conditions
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Intubated Patients, Percutaneous Tracheostomy

Intervention / Treatment
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* Device: C-MAC videolayngoscopy technique
* Device: Laryngoscopy technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ICU intubated patients that require a percutaneous dilational tracheostomy for clinical reasons (prolonged mechanical ventilation, airway protection or weaning failure). Exclusion Criteria: Patients younger than 18 years and older than 85 years Trachea and neck abnormalities. Soft tissue infection in the neck. History of neck surgery. Coagulation disorders or changes in coagulation parameters (platelet count < 50.000 mm3, an activated partial thromboplastin time 1.5-fold longer than the control value, and international normalized ratio > 1.5). Consent refusal for participating in the trial.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional direct laryngoscopy technique<br>Endotracheal tube will be removed before percutaneous tracheostomy using a traditional direct laryngoscopy technique. | Device: Laryngoscopy technique<br>* Endotracheal tube will be removed before percutaneous tracheostomy using a laryngoscopy<br>|
| Active Comparator: C-MAC videolaryngoscope technique<br>Endotracheal tube will be removed before percutaneous tracheostomy using a C-MAC videolaryngoscope technique. | Device: C-MAC videolayngoscopy technique<br>* Endotracheal tube will be removed before percutaneous tracheostomy using a C-MAC videolaryngoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Introduction of the Seldinger needle below the endotracheal tube | Percentage of patients in whom the introduction of the Seldinger needle is below the tip of the endotracheal tube | during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Puncture of the cuff of the endotracheal tube with the Seldinger needle | Percentage of patients suffering puncture the cuff of the endotracheal tube with the Seldinger needle | during the procedure | 
| patients who need to remove the endotracheal tube to introduce the percutaneous tracheostomy cannula | Percentage of patients who need to remove the endotracheal tube to introduce the percutaneous tracheostomy cannula | during the procedure | 
| Laryngoscopy vision using de Modified Cormack-Lehane grade of glottic view | Differences in laryngoscopy vision using de modified Cormack-Lehane grade of glottic view Modified Cormack-Lehane grade of glottic view: I: full view of the glottis (better outcome) 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 (worse outcome) | during the procedure | 
| Difficulty of removing the endotracheal tube | Differences in the difficulty of removing the endotracheal tube due to poor visualization, secretions.... Operator-assessed subjective difficulty of removing the endotracheal tube: No difficulty, mild difficulty, moderate difficulty, severe difficulty. | during the procedure | 
| Difficulty of performing percutaneous tracheotomy | Differences in the difficulty of performing percutaneous tracheotomy Operator-assessed subjective difficulty of performing percutaneous tracheotomy: No difficulty, mild difficulty, moderate difficulty, severe difficulty. | during the procedure | 
| Complications | Percentage of complications | during the ICU stay | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tracheostomy, Critical care, Videolaryngoscopy, Direct laryngoscopy, Airway management