Tracheostomy Complications
Conditions
Keywords
tracheostomy, complications, ultrasound, bronchoscopy
Brief summary
Trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy and bronchoscopy guided percutaneous tracheostomy.
Detailed description
Trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy and bronchoscopy guided percutaneous tracheostomy. Patients will be randomly assigned to be submitted to evaluate safety, complication rates, easy to perform , clinical outcomes and effectivity.
Interventions
Ultrasound guided percutaneous tracheostomy
Bronchoscopy guided percutaneous tracheostomy
Sponsors
Prof.Dr.A.İlhan Özdemir State Hospital
Aykut Saritas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All intubated and mechanically ventilated patients indicated for a tracheostomy
Exclusion criteria
* Patients with tracheal or neck abnormalities, soft tissue infection in the neck, neck surgery history, oxygenation problems , coagulation disorders or coagulation parameter changes and those requiring urgent or surgery patients unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| procedure failure of ultrasound to provide this anatomical information and ease of perform | During percutaneous tracheostomy an expected average time 20 minutes | occurence of a major complications: bleeding, subcutaneous emphysema, oesophageal perforation, number of applied needle interventions, procedure duration, cardiorespiratory arrest |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| procedure time | during percutaneous tracheostomy ( average expected time 20 minutes) | the procedure duration was taken as the time that elapsed from the placement of the needle to the placement of the tracheostomy cannula. |
| Pneumothorax | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | Pneumothorax due to the percutaneous tracheostomy detected by clinical examination during the procedure or chest x-ray after the procedure. |
| 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 |
| Cardiorespiratory arrest | during percutaneous tracheostomy an expected average of 20 minutes | Cardiorespiratory arrest due to percutaneous tracheostomy |
| Minor bleeding | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | Haemorrhage that could not be stopped by sponge wrapping the stoma after the procedure and/or blood coming with aspiration inside the tracheostomy tube was defined as minor bleeding |
| Major bleeding | During the procedure an expected average of 20 minutes | Continuous haemorrhage from the stoma and/or from the trachea with aspiration despite compresses was defined as a major haemorrhage. |
| Accidental decannulation | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | Accidental decannulation after the procedure during Hospital stay |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hypoxemia | During percutaneous tracheostomy an expected average of 20 minutes | Drop in peripheral oxygen saturation \< 90% for more than 2 minutes as measured by pulse oximeter during the procedure |
Outcome results
None listed