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Идёт набор NCT07465302

Treating Spinal Cord Injury With Early Normobaric Hyperoxia

Фаза II С лечением Traumatic Spinal Cord Injuries

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Normobaric Hyperoxia.
Кому может быть актуально
Состояния в реестре: Traumatic Spinal Cord Injuries. Базовые параметры: 18 лет — 85 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Treating Spinal Cord Injury With Early Normobaric Hyperoxia - A Phase IIa Feasibility Trial

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое Normobaric Hyperoxia
    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.

Первичные конечные точки

  • Feasibility of early normobaric hyperoxic therapy [Срок оценки: 24 hours from injury]
  • Preliminary efficacy of intermittent normobaric hyperoxia in achieving high oxygen concentrations systemically [Срок оценки: From enrollment to the end of intervention period at 5 days]
  • Preliminary safety of intermittent normobaric hyperoxia [Срок оценки: From completion of first treatment to end of 6 month follow up period]
Вторичные конечные точки (6)
  • Feasibility of intermittent therapeutic hyperoxemia and elevated oxygen concentration [Срок оценки: From enrollment to the end of intervention period at 5 days]
  • Exploratory safety objectives [Срок оценки: From enrollment to end of 6 month follow up period]
  • Feasibility - Timely Placement of Lumbar Drain [Срок оценки: Time of injury to 24hr post injury.]
  • Feasibility - Completion of Required Monitoring Lines [Срок оценки: Day 0 to day 5]
  • Protocol Adherence - Sampling Deviations [Срок оценки: Enrollment to end of 6 month follow up period]
  • Sample Handling - Discarded Specimens [Срок оценки: From enrollment to end of 6 month follow up period]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Florida — Gainesville

Идентификаторы

NCT: NCT07465302 · IRB202400873 · 4R00GM159353-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗