Status:
TERMINATED
A Prospective, Randomized Trial of Early Versus Late Tracheostomy in Trauma Patients With Severe Brain Injury
Lead Sponsor:
Memorial Medical Center
Conditions:
Respiratory Failure
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 pat...
Detailed Description
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, dilatati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00292097
Start Date
February 1 2006
End Date
May 1 2008
Last Update
June 5 2008
Active Locations (1)
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1
Memorial Medical Center
Johnstown, Pennsylvania, United States, 15905