Treating Spinal Cord Injury With Early Normobaric Hyperoxia - A Phase IIa Feasibility Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Feasibility of early normobaric hyperoxic therapy
研究概览
简要总结
SpiCoH is a phase IIa, single center, open-label, clinical trial of intermittent normobaric hyperoxia in mechanically ventilated patients with traumatic cervical and/or thoracic spinal cord injury.
详细描述
Intermittent normobaric hyperoxia (NBH) by increasing FiO2 to 100% for a duration of 4.5h (270 min), twice daily over five consecutive days. Instead of fixed 12-hour intervals between sessions, the two daily treatments will follow a pre-specified interval: a minimum of 1.5h (90min) between sessions for treatment B, and 10h (600min) for treatment A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated ICF by the subject or LAR
- •Stated willingness to comply with all study procedures for the duration of the study
- •Male or female subjects, aged ≥18 and ≤ 85 years
- •Admitted with a diagnosis of blunt or penetrating traumatic cervical and/or thoracic SCI (maintaining dural sac integrity)
- •Awake and able to interact and follow commands
- •American Spinal Injury Association (ASIA) Impairment Scale (AIS) grades A, B or C
- •Need for mechanical ventilation (MV), as determined by the treating physician
- •Baseline PaO2 >80 mmHg before enrollment
- •Capacity to initiate the study intervention within 24 hours of injury
排除标准
- •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
研究组 & 干预措施
Intervention
Normobaric hyperoxia
干预措施: Normobaric Hyperoxia (Other)
结局指标
主要结局
Feasibility of early normobaric hyperoxic therapy
时间窗: 24 hours from injury
Proportion of subjects receiving first normobaric hyperoxia therapy.
Preliminary efficacy of intermittent normobaric hyperoxia in achieving high oxygen concentrations systemically
时间窗: From enrollment to the end of intervention period at 5 days
Serial PaO2
Preliminary safety of intermittent normobaric hyperoxia
时间窗: From completion of first treatment to end of 6 month follow up period
Four-point end-organ toxicity surveillance.
次要结局
- Feasibility of intermittent therapeutic hyperoxemia and elevated oxygen concentration(From enrollment to the end of intervention period at 5 days)
- Exploratory safety objectives(From enrollment to end of 6 month follow up period)
- Feasibility - Timely Placement of Lumbar Drain(Time of injury to 24hr post injury.)
- Feasibility - Completion of Required Monitoring Lines(Day 0 to day 5)
- Protocol Adherence - Sampling Deviations(Enrollment to end of 6 month follow up period)
- Sample Handling - Discarded Specimens(From enrollment to end of 6 month follow up period)