Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT05416489

C-MAC Videolaryngoscopy Versus Direct Laryngoscopy for Percutaneous Tracheostomy

Led by Hospital Clinico Universitario de Santiago · Updated on 2025-09-15

90

Participants Needed

2

Research Sites

234 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

C-MAC Videolaryngoscopy Versus Direct Laryngoscopy for Percutaneous Tracheostomy

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ICU intubated patients that require a percutaneous dilational tracheostomy for clinical reasons such as prolonged mechanical ventilation, airway protection, or weaning failure
Not Eligible

You will not qualify if you...

  • 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, activated partial thromboplastin time 1.5-fold longer than control value, international normalized ratio > 1.5)
  • Consent refusal for participating in the trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University Clinical Hospital of Santiago de Compostela

Santiago de Compostela, A Coruña, Spain, 15866

Actively Recruiting

2

University Clinical Hospital of Santiago de Compostela

Santiago de Compostela, A Coruña, Spain, 15866

Actively Recruiting

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Research Team

M

Manuel Taboada, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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C-MAC Videolaryngoscopy Versus Direct Laryngoscopy for Percutaneous Tracheostomy | DecenTrialz