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C-MAC Videolaryngoscopy Versus Direct Laryngoscopy for Percutaneous Tracheostomy

Not Applicable
Recruiting
Conditions
Intubated Patients
Percutaneous Tracheostomy
Interventions
Device: C-MAC videolayngoscopy technique
Device: Laryngoscopy technique
Registration Number
NCT05416489
Lead Sponsor
Hospital Clinico Universitario de Santiago
Brief Summary

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

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
90
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
C-MAC videolaryngoscope techniqueC-MAC videolayngoscopy techniqueEndotracheal tube will be removed before percutaneous tracheostomy using a C-MAC videolaryngoscope technique.
Traditional direct laryngoscopy techniqueLaryngoscopy techniqueEndotracheal tube will be removed before percutaneous tracheostomy using a traditional direct laryngoscopy technique.
Primary Outcome Measures
NameTimeMethod
Introduction of the Seldinger needle below the endotracheal tubeduring the procedure

Percentage of patients in whom the introduction of the Seldinger needle is below the tip of the endotracheal tube

Secondary Outcome Measures
NameTimeMethod
Complicationsduring the ICU stay

Percentage of complications

patients who need to remove the endotracheal tube to introduce the percutaneous tracheostomy cannuladuring the procedure

Percentage of patients who need to remove the endotracheal tube to introduce the percutaneous tracheostomy cannula

Laryngoscopy vision using de Modified Cormack-Lehane grade of glottic viewduring the procedure

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)

Difficulty of performing percutaneous tracheotomyduring the procedure

Differences in the difficulty of performing percutaneous tracheotomy Operator-assessed subjective difficulty of performing percutaneous tracheotomy: No difficulty, mild difficulty, moderate difficulty, severe difficulty.

Puncture of the cuff of the endotracheal tube with the Seldinger needleduring the procedure

Percentage of patients suffering puncture the cuff of the endotracheal tube with the Seldinger needle

Difficulty of removing the endotracheal tubeduring the procedure

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.

Trial Locations

Locations (1)

University Clinical Hospital of Santiago de Compostela

🇪🇸

Santiago de Compostela, A Coruña, Spain

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