Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 488506 | Other Identifier | CAPPesq |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound | Experimental | Ultrasound guided percutaneous tracheostomy |
|
| Bronchoscopy | Active Comparator | Bronchoscopy guided percutaneous tracheostomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound guided percutaneous tracheostomy | Device | Ultrasound guided percutaneous tracheostomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During PDT - an expected average of 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoxemia | Drop in peripheral oxygen saturation < 90% for more than 2 minutes as measured by pulse oxymeter during the procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure duration | Time elapsed between skin incision and connection of mechanical ventilation to tracheostomy cannula | During PDT - an expected average of 15 minutes |
| Time to procedure performance | Time elapsed between participant randomization and PDT performance |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| André Gobatto, MD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Cínicas da Universidade de São Paulo | São Paulo | São Paulo | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bronchoscopy guided percutaneous tracheostomy | Device | Bronchoscopy guided percutaneous tracheostomy |
|
| 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. | 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. | 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. | During PDT - an expected average of 15 minutes |
| Tracheal posterior wall injury | Tracheal posterior wall injury as detected by bronchoscopy after the procedure | 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 | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Cardiorespiratoty arrest | Cardiorespiratory arrest due to PDT | During PDT - an expected average of 15 minutes |
| Death | Death due to PDT complications | 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 | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Length of ICU Stay | Length of ICU Stay | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Length of Hospital Stay | Length of Hospital Stay | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Length of Mechanical Ventilation | Length of Mechanical Ventilation | 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 | 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 | 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 | 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. | 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 | 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 | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |