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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound guided percutaneous tracheostomy | Experimental | The PDT will be performed by the attending physician exclusively with the aid of the ultrasound. |
|
| Bronchoscopy guided percutaneous tracheostomy | Active Comparator | The PDT will be performed by the attending physician exclusively with the aid of the bronchoscope. |
|
| Ultrasound-bronchoscopy guided percutaneous tracheostomy | Active Comparator | The PDT will be performed by the attending physician with the aid of the ultrasound and bronchoscope. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous dilatational tracheostomy | Procedure | Percutaneous dilatational tracheostomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| PDT 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. | During PDT - 15-25 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Minor complication - hypotension | a drop of MAP<65 mmHg for less than 5 minutes without the requirement of fluids or vasopressors | During PDT (an expected average of 15-30 minutes) |
| Procedure difficulty |
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Inclusion Criteria:
Exclusion Criteria:
Patients with contraindications for PDT:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catalin Constantinescu, MD, PhD | Contact | 0040743903224 | constantinescu.catalin@ymail.com | |
| Olga Grajdieru, MD | Contact | olgadoinag@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Cristina Petrisor, Prof | Iuliu Hatieganu University of Medicine and Pharmacy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency County Clinical Hospital | Recruiting | Cluj-Napoca | Cluj | 400006 | Romania |
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Enrolled patients will be randomized in a 1:1:1 ratio to ultrasound or bronchoscopy or ultrasound-bronchoscopy percutaneous dilatational tracheostomy.
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(1) easy, (2) somewhat difficult, (3) difficult, (4) very difficult, or (5) impossible
| During PDT (an expected average of 15-30 minutes) |
| ICU mortality | We will measure ICU mortality at the discharge and 60 days after discharge. | During hospital LOS (an expected average of 4 weeks ) |
| Hospital mortality | We will measure hospital mortality at the discharge and 60 days after discharge. | 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. | During PDT (an expected average of 15-30 minutes) |
| Mechanical ventilation | Days of MV before and after PDT | During hospital LOS (an expected average of 4 weeks) |
| 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 | During PDT (an expected average of 15-30 minutes) |
| Minor complication - Accidental decannulation | Accidental decannulation | During hospital LOS (an expected average of 4 weeks) |
| Minor complication - Tracheostomy stoma infection | Tracheostomy stoma infection | During hospital LOS (an expected average of 4 weeks) |
| Minor complication - Localized minor bleeding | Localized minor bleeding | During PDT (an expected average of 15-30 minutes) |
| Minor complication - Localized subcutaneous emphysema | Localized subcutaneous emphysema | During PDT (an expected average of 15-30 minutes) |
| Lenght of ICU stay | Lenght of ICU stay | (an expected average of 4 weeks) |
| Lenght of hospital stay | Lenght of hospital stay | (an expected average of 4 weeks) |