Clinical trial NCT05416489: C-MAC Videolaryngoscopy Versus Direct Laryngoscopy for Percutaneous Tracheostomy
Official title: Videolaryngoscopy Versus Direct Laryngoscopy for Positioning the Tracheal Tube During Percutaneous Tracheostomy: a Randomized Controlled Trial (VIDLARTRAQUEO).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intubated Patients
Percutaneous Tracheostomy
Keywords: Tracheostomy
Critical care
Videolaryngoscopy
Direct laryngoscopy
Airway management
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Introduction of the Seldinger needle below the endotracheal tube
timeFrame: during the procedure
Secondary outcomes:
measure: Puncture of the cuff of the endotracheal tube with the Seldinger needle
timeFrame: during the procedure
measure: patients who need to remove the endotracheal tube to introduce the percutaneous tracheostomy cannula
timeFrame: during the procedure
measure: Laryngoscopy vision using de Modified Cormack-Lehane grade of glottic view
timeFrame: during the procedure
measure: Difficulty of removing the endotracheal tube
timeFrame: during the procedure
measure: Difficulty of performing percutaneous tracheotomy
timeFrame: during the procedure
measure: Complications
timeFrame: during the ICU stay
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: University Clinical Hospital of Santiago de Compostela
state: A Coruña
city: Santiago de Compostela
country: Spain
facility: University Clinical Hospital of Santiago de Compostela
state: A Coruña
Study officials:
References:
citation: Johnson-Obaseki S, Veljkovic A, Javidnia H. Complication rates of open surgical versus percutaneous tracheostomy in critically ill patients. Laryngoscope. 2016 Nov;126(11):2459-2467. doi: 10.1002/lary.26019. Epub 2016 Apr 14.