Ultrasound Guided Percutaneous Tracheostomy Compared to Bronchoscopy Guided Percutaneous Tracheostomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ultrasound Guided Percutaneous Tracheostomy Compared to Bronchoscopy Guided Percutaneous Tracheostomy - A Randomized Non-inferiority Trial

Conditions
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Tracheostomy Complications

Intervention / Treatment
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* Device: Ultrasound guided percutaneous tracheostomy
* Device: Bronchoscopy guided percutaneous tracheostomy


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound<br>Ultrasound guided percutaneous tracheostomy | Device: Ultrasound guided percutaneous tracheostomy<br>* Ultrasound guided percutaneous tracheostomy<br>|
| Active Comparator: Bronchoscopy<br>Bronchoscopy guided percutaneous tracheostomy | Device: Bronchoscopy guided percutaneous tracheostomy<br>* Bronchoscopy guided percutaneous tracheostomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tracheostomy, Ultrasound