TRACHUS trial is a randomized non-inferiority trial designed to evaluate the safety and efficacy of ultrasound guided percutaneous tracheostomy compared to bronchoscopy guided percutaneous tracheostomy.
TRACHUS trial is a randomized non-inferiority trial designed to evaluate the safety and efficacy of ultrasound guided percutaneous tracheostomy compared to bronchoscopy guided percutaneous tracheostomy. Patients will be randomly assigned to be submitted to ultrasound or bronchoscopy guided percutaneous tracheostomy and then the procedure related complications and clinical outcomes will be evaluated and compared between groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
118
Ultrasound guided percutaneous tracheostomy
Bronchoscopy guided percutaneous tracheostomy
Hospital das Cínicas da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Procedure failure
Combined endpoint procedure failure (defined as conversion to surgical tracheostomy, or associated use of bronchoscopy in the case of ultrasound-guided tracheostomy or associated use of ultrasound in bronchoscopy-guided tracheostomy) or occurrence of of a major complications defined as transfusion, hypotension or surgical intervention in the operative room due to bleeding, tracheal laceration, tracheal posterior wall injury, esophageal injury, tracheoesophageal fistula, cardiorespiratory arrest or death due to tracheostomy.
Time frame: During PDT - an expected average of 15 minutes
Hypoxemia
Drop in peripheral oxygen saturation \< 90% for more than 2 minutes as measured by pulse oxymeter during the procedure
Time frame: During PDT - an expected average of 15 minutes
Hypotension
Systolic blood pressure \< 90mmHg for more than 5 minutes and any intervention aimed to raise blood pressure such as vasopressor or fluid administration.
Time frame: During PDT - an expected average of 15 minutes
Pneumothorax
Pneumothorax due to the PDT detected by clinical examination during the procedure or chest x-ray after the procedure.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Atelectasis
Atelectasis due to the PDT detected by clinical examination during the procedure or chest x-ray after the procedure.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Conversion to surgical tracheostomy
Conversion to surgical tracheostomy due to technical limitations or complications during PDT.
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Time frame: During PDT - an expected average of 15 minutes
Tracheal posterior wall injury
Tracheal posterior wall injury as detected by bronchoscopy after the procedure
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Accidental decanulation
Accidental decanulation after the procedure during Hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Cardiorespiratoty arrest
Cardiorespiratory arrest due to PDT
Time frame: During PDT - an expected average of 15 minutes
Death
Death due to PDT complications
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Liberation from mechanical ventilation
Breathing without ventilator assistance for at least 48 hours after the PDT
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Length of ICU Stay
Length of ICU Stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Length of Hospital Stay
Length of Hospital Stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Length of Mechanical Ventilation
Length of Mechanical Ventilation
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Surgical site infection
Surgical site infection defined as antibiotic introduction directed to surgical site
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Tracheal ring fracture
Tracheal ring fracture detected by bronchosocopy after the PDT
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Tracheal-esophageal fistula
Trachealesophageal fistula detected by bronchosocopy after PDT
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Minor bleeding
Clinical relevant bleeding attributed to PDT defined as need for any intervention to stop the bleeding such as vessel ligature or local wound care.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Major bleeding
Blood transfusion or hypotension or surgical intervention in the operating room due to bleeding during PDT
Time frame: During the procedure - an expected average of 15 minutes
Major bleeding
Blood transfusion or hypotension or surgical intervention in the operating room due to bleeding related to PDT during hospital stay after the procedure
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks