This trial (BRONCUS) is a randomized one designed to evaluate the overall safety of ultrasound guided compared to bronchoscopy guided compared to ultrasound-bronchoscopy guided percutaneous tracheostomy, in order to find out if universal standardization is required or customized approach can be sufficient.
Enrolled patients will be randomized in a 1:1:1 ratio to ultrasound or bronchoscopy or ultrasound-bronchoscopy arms, and then the procedure related complications and clinical outcomes will be evaluated and compared between the groups. The procedures will be performed according to standardized practices following hospital guidelines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
150
Percutaneous dilatational tracheostomy
Emergency County Clinical Hospital
Cluj-Napoca, Cluj, Romania
RECRUITINGPDT feasibility/failure
Conversion to a surgical tracheostomy in any case, associated use of bronchoscopy in the case of ultrasound-guided PDT, associated use of ultrasound in the case of bronchoscopy-guided PDT, or the occurrence of a major complication.
Time frame: During PDT - 15-25 minutes
Minor complication - hypotension
a drop of MAP\<65 mmHg for less than 5 minutes without the requirement of fluids or vasopressors
Time frame: During PDT (an expected average of 15-30 minutes)
Procedure difficulty
(1) easy, (2) somewhat difficult, (3) difficult, (4) very difficult, or (5) impossible
Time frame: During PDT (an expected average of 15-30 minutes)
ICU mortality
We will measure ICU mortality at the discharge and 60 days after discharge.
Time frame: During hospital LOS (an expected average of 4 weeks )
Hospital mortality
We will measure hospital mortality at the discharge and 60 days after discharge.
Time frame: During hospital LOS (an expected average of 4 weeks)
Procedure duration
We will measure the procedure duration from the point beginning of the procedure and the end of it.
Time frame: During PDT (an expected average of 15-30 minutes)
Mechanical ventilation
Days of MV before and after PDT
Time frame: During hospital LOS (an expected average of 4 weeks)
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Minor complication - hypoxemia
A drop in peripheral oxygen saturation \< 90% for more than 2 minutes as measured by pulse oxymeter during the procedure while the patient is of 100% FiO2
Time frame: During PDT (an expected average of 15-30 minutes)
Minor complication - Accidental decannulation
Accidental decannulation
Time frame: During hospital LOS (an expected average of 4 weeks)
Minor complication - Tracheostomy stoma infection
Tracheostomy stoma infection
Time frame: During hospital LOS (an expected average of 4 weeks)
Minor complication - Localized minor bleeding
Localized minor bleeding
Time frame: During PDT (an expected average of 15-30 minutes)
Minor complication - Localized subcutaneous emphysema
Localized subcutaneous emphysema
Time frame: During PDT (an expected average of 15-30 minutes)
Lenght of ICU stay
Lenght of ICU stay
Time frame: (an expected average of 4 weeks)
Lenght of hospital stay
Lenght of hospital stay
Time frame: (an expected average of 4 weeks)