A Prospective Trial of Elective Extubation in Brain Injured Patients.
Completed · Phase 1
Conditions studied: Brain Injury
In brief
Identifying the optimal time of extubation in a brain injured population should improve patient outcome. Brain injured patients usually remain intubated due to concerns of airway maintenance. Current practice argues that unconscious patients need to remain intubated to protect their airways. More recent data however suggests that delaying extubation in this population increases pneumonias and worsens patient outcomes. We designed a safety and feasibility study of randomizing brain injured patients into early or delayed extubation. The purpose was to gain insight into patient safety concerns and to obtain estimates of sample size needed for a larger study.
Key facts
- Study ID
- NCT00729261
- Run by
- Mayo Clinic
- People needed
- 16
- Starts
- 2004-08-01
- Expected to finish
- 2006-05-01
- Last updated by the study team
- 2015-04-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Resolution or improvement of any pulmonary process requiring mechanical ventilation.
- Adequate gas exchange.
- Adequate ventilation.
- Respiratory rate to tidal volume ratio <105.
- Core body temperature < 38 degrees celsius.
- Hemoglobin > 8 grams per deciliter.
- No sedative medications for 2 hours.
- Neurological requirements included:
- GCS ≤ 8.
- Intracranial pressure (ICP) < 15 cm of water and a cerebral perfusion pressure (CPP) > 60 mm Hg for patients with intracranial pressure monitors.
You may not qualify if…
- Age < 18 years.
- Lack of informed consent by the patients' surrogate.
- Dependence on mechanical ventilation for at least two weeks prior to enrollment.
- Patients with tracheostomies.
- Intubation instituted for therapeutic hyperventilation.
- Planned surgical or radiological intervention within the next 72 hours.
- Anticipated neurological or medically worsening conditions (i.e develop cerebral edema or vasospasm).
- Patients intubated for airway preservation due to airway edema (cervical neck injuries or surgery) as opposed to airway protection.
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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