A Prospective, Randomized Trial of Early Versus Late Tracheostomy in Trauma Patients With Severe Brain Injury

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of early conversion tracheostomy from endotracheal intubation (ET) to percutaneous, dilatational tracheostomy (PDT) in traumatic brain-injured patients requiring prolonged mechanical ventilation.

Detailed Description
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This is a prospective, randomized trial to evaluate the efficacy of early (less than or equal to 72 hours) versus late (10 to 14 days) conversion from endotracheal intubation to percutaneous, dilatational, translaryngeal tracheostomy for mechanical ventilation of traumatic brain injured patients. The primary efficacy parameter will be the number of days on mechanical ventilation. Secondary objectives include: Number of days in the hospital To assess the incidence of ventilator-acquired pneumonia in each group To assess the incidence of accidental extubation in each group To assess the incidence of death in each group

Official Title
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A Prospective, Randomized Trial of Early Versus Conventional Conversion From Endotracheal Intubation to Percutaneous Tracheostomy for Ventilatory Support of Trauma Patients With Severe Brain Injury

Conditions
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Respiratory Failure, Traumatic Brain Injury

Intervention / Treatment
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* Procedure: Early tracheostomy
* Procedure: Late tracheostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older TBI defined as penetrating or blunt brain injury including 1)subarachnoid hemorrhage, 2)subdural hemorrhage, 3) epidural hemorrhage, 4)brain contusion, 5)diffuse axonal injury mechanically ventilated by endotracheal intubation projected to need ventilation support for more than 14 days according to: GCS measured in field less than or equal to 8 and a GCS on day 3 which remains less than or equal to 8 informed consent obtained from patient or legal representative Exclusion Criteria: less than 18 years of age projected to need ventilation support for less than 14 days anatomical deformity of the neck, including thyromegaly and cervical tumors previous tracheostomy uncontrolled coagulopathy existence of platelet count less than 50,000/mm2 anti-platelet agents clinical evidence of ongoing infection at the proposed tracheostomy site as per physician mechanical ventilation with a positive end-expiratory pressure greater than 12 cm H20 intubated more than 72 hours patient has undergone cricothyroidotomy cricoid cartilage, trachea, or sternal notch not palpable with neck in position

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: 1<br>Early conversion from endotracheal intubation to percutaneous tracheostomy for ventilator support of trauma patients with severe brain injury | Procedure: Early tracheostomy<br>* early conversion - less than or equal to 72 hours<br>|
| Active Comparator: 2<br>Conventional conversion from endotracheal intubation to percutaneous tracheostomy for ventilator support of trauma patients with severe brain injury | Procedure: Late tracheostomy<br>* Late conversion (10-14 days)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of mechanical ventilation days |  | until discharged | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of hospital days |  | until discharged | 
| Incidence of ventilator-associated pneumonia |  | until discharged | 
| Incidence of accidental extubation |  | until discharged | 
| Incidence of death |  | until discharged | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory failure, Tracheostomy, Percutaneous dilatation tracheostomy, Endotracheal Conversion, Traumatic brain injury