Brain Injury
Conditions
Keywords
mechanical ventilation, extubation, outcomes, brain injury
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 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.
Interventions
PROCEDUREextubation
Brian injured patients that remained intubation solely because of a depressed level of consciousness were randomized into immediate extubation or delayed extubation until their level of consciousness improved.All patients met standard ventilatory, and airway criteria for extubation.
PROCEDUREcontinued intubation
patients remain intubated until their Glasgow coma scores improve to greater than 8.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Resolution or improvement of any pulmonary process requiring mechanical ventilation. 2. Adequate gas exchange. 3. Adequate ventilation. 4. Respiratory rate to tidal volume ratio \<105. 5. Core body temperature \< 38 degrees celsius. 6. Hemoglobin \> 8 grams per deciliter. 7. No sedative medications for 2 hours. Neurological requirements included: 1. GCS ≤ 8. 2. Intracranial pressure (ICP) \< 15 cm of water and a cerebral perfusion pressure (CPP) \> 60 mm Hg for patients with intracranial pressure monitors.
Exclusion criteria
1. Age \< 18 years. 2. Lack of informed consent by the patients' surrogate. 3. Dependence on mechanical ventilation for at least two weeks prior to enrollment. 4. Patients with tracheostomies. 5. Intubation instituted for therapeutic hyperventilation. 6. Planned surgical or radiological intervention within the next 72 hours. 7. Anticipated neurological or medically worsening conditions (i.e develop cerebral edema or vasospasm). 8. Patients intubated for airway preservation due to airway edema (cervical neck injuries or surgery) as opposed to airway protection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Rankin Score | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| nosocomial pneumonias | hospital discharge |
| reintubations | hospital discharge |
| ICU length of stay | hospital discharge |
| hospital length of stay | hospital discharge |
Countries
United States
Outcome results
None listed