C-MAC Videolaryngoscopy Versus Direct Laryngoscopy for Percutaneous Tracheostomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2026-06-30

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.

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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.

Conditions

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Intubated Patients Percutaneous Tracheostomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Traditional direct laryngoscopy technique

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

Group Type ACTIVE_COMPARATOR

Laryngoscopy technique

Intervention Type DEVICE

Endotracheal tube will be removed before percutaneous tracheostomy using a laryngoscopy

C-MAC videolaryngoscope technique

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

Group Type ACTIVE_COMPARATOR

C-MAC videolayngoscopy technique

Intervention Type DEVICE

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

Interventions

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C-MAC videolayngoscopy technique

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

Intervention Type DEVICE

Laryngoscopy technique

Endotracheal tube will be removed before percutaneous tracheostomy using a laryngoscopy

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No