C-MAC Videolaryngoscopy Versus Direct Laryngoscopy for Percutaneous Tracheostomy (VIDLARTRAQ)

Hospital Clinico Universitario de Santiago

Status: Enrolling

Conditions: Intubated Patients; Percutaneous Tracheostomy

Treatments: Device: Laryngoscopy technique; Device: C-MAC videolayngoscopy technique

Study type: Interventional

Funder types: Other

Identifiers

NCT05416489

VIDLARTRAQUEO

Details and patient eligibility

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Traditional direct laryngoscopy technique

Active Comparator group

Description:

Endotracheal tube will be removed before percutaneous tracheostomy using a traditional direct laryngoscopy technique.

Treatment:

Device: Laryngoscopy technique

C-MAC videolaryngoscope technique

Active Comparator group

Description:

Endotracheal tube will be removed before percutaneous tracheostomy using a C-MAC videolaryngoscope technique.

Treatment:

Device: C-MAC videolayngoscopy technique