A Prospective, Randomized Trial of Early Versus Late Tracheostomy in Trauma Patients With Severe Brain Injury
Respiratory Failure, Traumatic Brain Injury
About this trial
This is an interventional treatment trial for Respiratory Failure focused on measuring Respiratory failure, Tracheostomy, Percutaneous dilatation tracheostomy, Endotracheal Conversion, Traumatic brain injury
Eligibility Criteria
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
Sites / Locations
- Memorial Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
1
2
Early conversion from endotracheal intubation to percutaneous tracheostomy for ventilator support of trauma patients with severe brain injury
Conventional conversion from endotracheal intubation to percutaneous tracheostomy for ventilator support of trauma patients with severe brain injury