Treating Spinal Cord Injury With Early Normobaric Hyperoxia

Exclusion Criteria10

• Evidence of traumatic brain injury by neuroimaging (either CT or MRI) including, but not limited to, traumatic subarachnoid hemorrhage, subdural hematoma, epidural hematoma, intracranial hemorrhage, parenchymal contusions, and blunt cerebrovascular injury grades II-V
• AIS grades D or E at time of arrival to hospital
• Persistent hypoxia requiring >40% FiO2 to maintain PaO2 >80 mmHg
• Concurrent injuries contraindicating lumbar drain placement, including, but not limited to: signs of infection at insertion site, elevated intracranial pressure, supratentorial mass lesion with mass effect, posterior fossa mass or uncorrected coagulopathy (thrombocytopenia <100,000/μL or International Normalized Ratio >1.5)
• Pre-existing neurologic conditions that would confound neurologic assessment or would make difficult to accurately assess neurologic and/or functional outcomes
• Pre-existing respiratory or pulmonary conditions that would impact ventilation mechanics or confound the assessment of respiratory recovery
• Participation in a concurrent investigational/interventional study (observational studies allowed)
• Known to be pregnant, or with a positive pregnancy test
• Vulnerable populations such as prisoners and inmates (abiding GCP per the study IRB)
• Patient has any other clinically significant medical condition as determined by the investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results