Tracheostomy Complications
Conditions
Keywords
Tracheostomy, Ultrasound
Brief summary
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.
Detailed description
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.
Interventions
Ultrasound guided percutaneous tracheostomy
Bronchoscopy guided percutaneous tracheostomy
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All intubated and mechanically ventilated patients indicated for a tracheostomy by the ICU assistant team
Exclusion criteria
* Patients with unfavorable anatomy judged by the patient assistant team (short neck, tracheal deviation, cervical anatomical anomaly, previous cervical surgery, cervical trauma or inability to perform neck extension), preference for surgical tracheostomy by the patient assistant team or patients unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure failure | During PDT - an expected average of 15 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Mechanical Ventilation | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | Length of Mechanical Ventilation |
| Length of Hospital Stay | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | Length of Hospital Stay |
| Hypoxemia | During PDT - an expected average of 15 minutes | Drop in peripheral oxygen saturation \< 90% for more than 2 minutes as measured by pulse oxymeter during the procedure |
| Hypotension | During PDT - an expected average of 15 minutes | Systolic blood pressure \< 90mmHg for more than 5 minutes and any intervention aimed to raise blood pressure such as vasopressor or fluid administration. |
| Pneumothorax | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | Pneumothorax due to the PDT detected by clinical examination during the procedure or chest x-ray after the procedure. |
| Atelectasis | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | Atelectasis due to the PDT detected by clinical examination during the procedure or chest x-ray after the procedure. |
| Conversion to surgical tracheostomy | During PDT - an expected average of 15 minutes | Conversion to surgical tracheostomy due to technical limitations or complications during PDT. |
| Tracheal posterior wall injury | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | Tracheal posterior wall injury as detected by bronchoscopy after the procedure |
| Accidental decanulation | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | Accidental decanulation after the procedure during Hospital stay |
| Minor bleeding | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | Clinical relevant bleeding attributed to PDT defined as need for any intervention to stop the bleeding such as vessel ligature or local wound care. |
| Major bleeding | During the procedure - an expected average of 15 minutes | Blood transfusion or hypotension or surgical intervention in the operating room due to bleeding during PDT |
| Cardiorespiratoty arrest | During PDT - an expected average of 15 minutes | Cardiorespiratory arrest due to PDT |
| Death | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | Death due to PDT complications |
| Liberation from mechanical ventilation | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | Breathing without ventilator assistance for at least 48 hours after the PDT |
| Length of ICU Stay | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | Length of ICU Stay |
| Surgical site infection | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | Surgical site infection defined as antibiotic introduction directed to surgical site |
| Tracheal ring fracture | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | Tracheal ring fracture detected by bronchosocopy after the PDT |
| Tracheal-esophageal fistula | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | Trachealesophageal fistula detected by bronchosocopy after PDT |
Other
| Measure | Time frame | Description |
|---|---|---|
| Procedure duration | During PDT - an expected average of 15 minutes | Time elapsed between skin incision and connection of mechanical ventilation to tracheostomy cannula |
| Time to procedure performance | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | Time elapsed between participant randomization and PDT performance |
Countries
Brazil
Outcome results
None listed