C-MAC Videolaryngoscopy Versus Direct Laryngoscopy for Percutaneous Tracheostomy

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Not applicable

Age range

18 years - 85 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

90 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (2)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

2 locations

Study team and timeline

Lead sponsor

Hospital Clinico Universitario de Santiago

Study start

Jan 1, 2022 Actual

Primary completion

Dec 30, 2026 Estimated

Study completion

Dec 30, 2026 Estimated

First posted

Jun 13, 2022 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts