Comparison Between Bronchoscopy and Real- Time Ultrasound Guided Percutaneous Tracheostomy

Study Overview
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Brief Summary
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Trial is a randomized study to compare between ultrasound guided percutaneous tracheostomy and bronchoscopy guided percutaneous tracheostomy.

Detailed Description
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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.

Official Title
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Comparison Between Bronchoscopy and Real- Time Ultrasound Guided Percutaneous Dilatational Tracheostomy for Safety, Complications and Efficiency in Critically Ill Patient

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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

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 of ultrasound to provide this anatomical information and ease of perform | occurence of a major complications: bleeding, subcutaneous emphysema, oesophageal perforation, number of applied needle interventions, procedure duration, cardiorespiratory arrest | During percutaneous tracheostomy an expected average time 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedure time | the procedure duration was taken as the time that elapsed from the placement of the needle to the placement of the tracheostomy cannula. | during percutaneous tracheostomy ( average expected time 20 minutes) | 
| Pneumothorax | Pneumothorax due to the percutaneous tracheostomy 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 | 
| 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 decannulation | Accidental decannulation after the procedure during Hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 
| Cardiorespiratory arrest | Cardiorespiratory arrest due to percutaneous tracheostomy | during percutaneous tracheostomy an expected average of 20 minutes | 
| Minor bleeding | 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 | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 
| Major bleeding | Continuous haemorrhage from the stoma and/or from the trachea with aspiration despite compresses was defined as a major haemorrhage. | During the procedure an expected average of 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tracheostomy, complications, ultrasound, bronchoscopy