Routine Use of FIBERoptic Bronchoscopic Guidance in Percutaneous TRACHeostomy

Study Overview
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Brief Summary
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Tracheostomy is one of the most frequently performed techniques in intensive care units. For some authors endoscopic guide as part of the percutaneous tracheostomy (PT) might reduces the incidence of serious complications. However, for others, endoscopic guide increases the procedure cost, increases airway pressure and PaCO2 and sometimes requires the presence of another physician. International guidelines conclude that there is insufficient evidence to support the routine use of bronchoscopy during PT in order to decrease the number of complications. In addition the routine use of endoscopic guide is heterogeneous according the results of six published nation surveys. Extensive randomized trials to compare PT with endoscopic guide and without endoscopic guide are needed in order to clarify this controversial issue. This constitutes the justification of this trial. Hypothesis: Percutaneous tracheotomy performed under endoscopic guide decreases the incidence of perioperative complications of the procedure.

Detailed Description
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Background Tracheostomy is one of the most frequently performed techniques in intensive care units (ICU). A few years after the description of the percutaneous dilatational tracheostomy (PDT), endoscopic guide as part of the technique was performed in four patients. The authors concluded that the endoscopic guide provided advantages to the realization of PDT. Other authors have state that endoscopy, significantly reduces the incidence of serious complications such as posterior tracheal tears, false passage, pneumothorax and subcutaneous emphysema. However, currently endoscopic guide as part of the percutaneous tracheostomy is controversial. Although for some authors its use reduces the number of complications, others found that endoscopic guide increases the procedure cost, increases airway pressure and PaCO2 and sometimes requires the presence of another physician. Thus, some do not consider it necessary when the physicians have enough experience with percutaneous tracheostomy. International guidelines conclude that there is insufficient evidence to support the routine use of bronchoscopy during percutaneous tracheostomy in order to decrease the number of complications. In addition the routine use of endoscopic guide is heterogeneous according the published surveys. Specifically, in Spain its use was the lowest of the six published nation surveys. Extensive randomized trials to compare percutaneous tracheostomy with endoscopic guide and without endoscopic guide are needed in order to clarify this controversial issue. This constitutes the justification of this trial. Hypothesis Percutaneous tracheotomy performed under endoscopic guidance decreases the incidence of perioperative complications of the procedure. Main goal - To assess the incidence of perioperative complications of percutaneous tracheotomy under endoscopic guide versus blind percutaneous tracheotomy. - To assess the ventilatory parameters during percutaneous tracheostomy with and without endoscopic control. Methodology Prospective, multicenter randomized study. Patients admitted to the ICU who need tracheostomy due to prolonged mechanical ventilation, who do not have neither contraindications to perform the percutaneous technique nor contraindications to perform fibrobronchoscopy will be randomized. The percutaneous tracheostomy will be carried out with the single-step dilation method. For its realization, the usual protocol will be followed. The included patients will be randomized 1:1 (percutaneous tracheostomy with endoscopic guide vs percutaneous tracheostomy without endoscopic guide). The randomization system will be by closed envelope. A sample size of 221 patients in each branch has been calculated. The percutaneous tracheostomy and fiberoptic bronchoscopy will be performed by staff with experience with both procedures.

Official Title
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The Role of Routine Fiberoptic Bronchoscopic Guidance During Percutaneous Tracheostomy. A Prospective Randomized Trial

Conditions
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Tracheostomy Complication

Intervention / Treatment
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* Device: endoscopic guidance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years old requiring tracheotomy due to prolonged mechanical ventilation That Family members or legal representatives have signed the information sheet and informed consent Exclusion Criteria: Patients with increased intracranial pressure according to intracranial pressure monitoring or suspected. Patients who have any absolute or relative contraindication for the percutaneous tracheostomy realization Patients with difficult airway

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: blind tracheotomy<br>no endoscopic guidance tracheotomy | |
| Experimental: endoscopic guidance tracheotomy<br>With endoscopic guidance tracheotomy | Device: endoscopic guidance<br>* Percutaneous tracheotomy performed by endoscopic guidance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with bleeding | Bleeding with haemodynamic derangement or needing surgical review or transfusion of packed red cells. | 24 hours | 
| Number of patients with hypoxemia | Hypoxemia: Oxygen arterial saturation (SaO2) < 85% during more than 90 seconds and/or arrhythmia or cardiac arrest related to hypoxemia. | During the procedure | 
| Number of patients in whom a loss of airway has ocurred | Loss of airway: Failure to be able to access the airway > 30 seconds. | During the procedure | 
| Number of patients with atelectasis | Atelectasis: Total or partial lung collapse not present before the technique, evidenced at postoperative control. | 24 hours | 
| Number of patients with hypotension | Hypotension requiring treatment with vasopressors or >1000 ml of fluids during the procedure. | During the procedure | 
| Number of patients with barotrauma | Barotrauma: Subcutaneous emphysema, mediastinal emphysema or pneumothorax related to the technique. | 24 hours | 
| Number of patients with posterior tracheal wall injury | Posterior tracheal wall injury: Injury to membranous trachea from needle, guide or dilator. | During the procedure | 
| Number of patients in whom false passage has ocurred | False passage: Dilatation or insertion of the cannula out of the trachea lumen. | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak airway pressure | Maximum peak airway pressure (cmH2O) | During the procedure | 
| Plateau pressure | Maximum plateau pressure (cmH2O) | During the procedure | 
| Tidal volume | Minimum tidal volume (mL) | During the procedure | 
| Arterial Blood Gas | Arterial blood gase at the beginning and the end of the procedure | 2 hours | 
| Oxygen saturation (SaO2) | Minimum arterial oxygen saturation (SaO2) | During the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous tracheostomy, Fiberoptic bronchoscopic guidance