Status:
COMPLETED
A Prospective Trial of Elective Extubation in Brain Injured Patients.
Lead Sponsor:
Mayo Clinic
Conditions:
Brain Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00729261
Start Date
August 1 2004
End Date
May 1 2006
Last Update
April 28 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Rochester, Minnesota, United States, 55905