Tracheostomy Complication, Tracheostomy Hemorrhage, Tracheostomy Infection
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Percutaneous dilatational tracheostomy
Sponsors
Iuliu Hatieganu University of Medicine and Pharmacy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Enrolled patients will be randomized in a 1:1:1 ratio to ultrasound or bronchoscopy or ultrasound-bronchoscopy percutaneous dilatational tracheostomy.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* adult patients (over 18 years old), intubated, mechanically ventilated, and with an indication for a tracheostomy
Exclusion criteria
Patients with contraindications for PDT: * short neck * tracheal deviation * difficult anatomy * previous neck surgery * cervical trauma or inability to perform neck extension * preference for surgical tracheostomy by the patient assistant team * patients unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PDT feasibility/failure | During PDT - 15-25 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure difficulty | During PDT (an expected average of 15-30 minutes) | (1) easy, (2) somewhat difficult, (3) difficult, (4) very difficult, or (5) impossible |
| ICU mortality | During hospital LOS (an expected average of 4 weeks ) | We will measure ICU mortality at the discharge and 60 days after discharge. |
| Hospital mortality | During hospital LOS (an expected average of 4 weeks) | We will measure hospital mortality at the discharge and 60 days after discharge. |
| Procedure duration | During PDT (an expected average of 15-30 minutes) | We will measure the procedure duration from the point beginning of the procedure and the end of it. |
| Mechanical ventilation | During hospital LOS (an expected average of 4 weeks) | Days of MV before and after PDT |
| Minor complication - hypoxemia | During PDT (an expected average of 15-30 minutes) | 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 |
| Minor complication - hypotension | During PDT (an expected average of 15-30 minutes) | a drop of MAP\<65 mmHg for less than 5 minutes without the requirement of fluids or vasopressors |
| Minor complication - Tracheostomy stoma infection | During hospital LOS (an expected average of 4 weeks) | Tracheostomy stoma infection |
| Minor complication - Localized minor bleeding | During PDT (an expected average of 15-30 minutes) | Localized minor bleeding |
| Minor complication - Localized subcutaneous emphysema | During PDT (an expected average of 15-30 minutes) | Localized subcutaneous emphysema |
| Lenght of ICU stay | (an expected average of 4 weeks) | Lenght of ICU stay |
| Lenght of hospital stay | (an expected average of 4 weeks) | Lenght of hospital stay |
| Minor complication - Accidental decannulation | During hospital LOS (an expected average of 4 weeks) | Accidental decannulation |
Countries
Romania
Contacts
Primary ContactCatalin Constantinescu, MD, PhD
Backup ContactOlga Grajdieru, MD
Outcome results
None listed