Treating Spinal Cord Injury With Early Normobaric Hyperoxia
A legfontosabb adatok
- Hol
- Gainesville (Egyesült Államok)A helyszín megnézése
- Fázis
- 2. fázis
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 85 év között vagy?
Forrás: NCT07465302: ki vehet részt
Helyszínek itt: Egyesült Államok
- University of FloridaGainesville, Egyesült ÁllamokContact: Andrew KlineRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- University of Florida
- Azonosító
- NCT07465302
- A regiszteradat frissítve
- 2026. november 9.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Treating Spinal Cord Injury With Early Normobaric Hyperoxia - A Phase IIa Feasibility Trial
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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); Participation in a concurrent investigational/interventional study (observational studies allowed); 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; 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; 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; AIS grades D or E at time of arrival to hospital; Persistent hypoxia requiring >40% FiO2 to maintain PaO2 >80 mmHg; Known to be pregnant, or with a positive pregnancy test; Vulnerable populations such as prisoners and inmates (abiding GCP per the study IRB).