Status:
COMPLETED
Inhaled Nitric Oxide in Brain Injury
Lead Sponsor:
University of Cincinnati
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the changes in respiratory mechanics following traumatic brain injury and determine the effect of inhaled nitric oxide on gas exchange.
Detailed Description
Intubation and mechanical ventilation are common treatments in the care of patients with traumatic brain injury (TBI). Intubation allows for airway control and facilitates removal of respiratory secre...
Eligibility Criteria
Inclusion
- Hospital admission with traumatic brain injury (penetrating or blunt)
- Requirement for mechanical ventilation
- Glasgow Coma Score \> 3
Exclusion
- Brain death
- Expected survival \< 48 hours
- Air leak (bronchopleural fistula, tracheal injury)
- Current inspired oxygen concentration (FiO2) \> 0.65
- Hemodynamic instability (systolic blood pressure \< 100 mm Hg, cardiac arrhythmia)
- Uncontrolled intracranial pressure (\> 20 mm Hg)
- Spinal cord injury with hypotension
- Severe acute respiratory distress syndrome (ARDS) (PaO2/FiO2 \< 100)
- Chest abbreviated injury score (AIS) \> 3
- First rib fracture
- Flail chest
Key Trial Info
Start Date :
December 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03260569
Start Date
December 12 2018
End Date
December 28 2023
Last Update
April 30 2025
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45267