A Prospective, Randomized Trial of Early Versus Late Tracheostomy in Trauma Patients With Severe Brain Injury
Stopped early · Not applicable
Conditions studied: Respiratory Failure, Traumatic Brain Injury
In brief
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.
Key facts
- Study ID
- NCT00292097
- Run by
- Memorial Medical Center
- People needed
- 5
- Starts
- 2006-02-01
- Expected to finish
- 2008-05-01
- Last updated by the study team
- 2008-06-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Memorial Medical Center — Johnstown, Pennsylvania, United States
Full record on ClinicalTrials.gov
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