Acute Stroke, Ischemic Stroke, Acute
Conditions
Keywords
Acute stroke, Normobaric oxygen, Stroke neuroprotection
Brief summary
The primary purpose of this study is to explore the feasibility and safety of normobaric oxygen therapy (NBO) under pre-hospital condition in patients with suspected stroke.
Detailed description
Despite the application of thrombolytic drugs and endovascular treatment, there is still a gap between the successful recanalization and ideal clinical outcomes for stroke patients. Neuroprotective treatment is considered as a promising adjuvant to ameliorate this situation. Previous researches demonstrated the neuroprotective effects of Normobaric Hyperoxia (NBO) in animal models from multiple perspectives. Moreover, NBO is distinctive for its ubiquity, conveniency, high compatibility, and wide adaptability, making it superior to other neuroprotective interventions in a pre-hospital setting. Therefore, the investigators conducted this pilot study to further explore the feasibility and safety of NBO under a pre-hospital condition in patients with suspected stroke.
Interventions
DRUGNBO
Oxygen inhalation through a mask at a rate of 10 L/min at 1 absolute atmosphere pressure (1 ATA = 101.325 kPa)
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or more. 2. Suspected stroke screened by the Gaze- Face Arm Speech Time scale (G-FAST score ≥ 1). 3. Within 24 hours of symptom onset 4. SpO2 \> 94%.
Exclusion criteria
1. Coma: Glasgow coma score (GCS) \< 8. 2. Hypoglycemia: Blood glucose \< 2.8mmol /L. 3. Known history of seizure. 4. Recent stroke or brain trauma within past 30 days. 5. Previous Modified Rankin Scale (mRS) ≥2. 6. Rapid improvement of neurological dysfunction (deficit present less than 15 min). 7. Unstable vital signs. 8. Known respiratory distress, respiratory dysfunction, or any contraindications to high-flow oxygen inhalation therapy. 9. Patient unable to cooperate with the trial procedure. 10. Any condition which might increase the risk to the patient in the judgment of the investigator. 11. Patient or available legally authorized representative unable to provide written or witnessed oral consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time intervals of the prehospital transportation process | Day 1 | Time intervals between stroke onset, paramedic arrival on the scene, the departure from the scene, and admission to the hospital emergency department. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | From the date of recruitment initiation until the date of recruitment completion, assessed up to 24 months. | The rate of patients successfully recruited to the trial by prehospital paramedics. |
| Final diagnosis | From the date of recruitment initiation until the date of recruitment completion, assessed up to 24 months. | The final diagnosis of the patients enrolled in the trial. |
| Safety Outcome | Day 1 | Incidence of adverse events during oxygen inhalation reported by the ambulance nurses. |
| Systemic immune-inflammation index (SII) | Day 1 | Systemic immune-inflammation index (SII) is calculated with the formula SII = (Peripheral platelet counts× Neutrophil counts)/Lymphocyte counts. |
| Neutrophil-to-lymphocyte ratio (NLR) | Day 1 | Neutrophil to lymphocyte ratio (NLR) is calculated as the absolute count of neutrophils divided by the absolute count of lymphocytes. |
| Plateletto-lymphocyte ratio(PLR) | Day1 | The platelet-to-lymphocyte ratio (PLR) is calculated as the absolute count of platelet divided by the absolute count of lymphocytes. |
Countries
China
Outcome results
None listed