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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normobaric Oxygen Inhalation Group | Experimental | Participants in the intervention group will receive oxygen inhalation through a mask at a rate of 10 L/min at 1 absolute atmosphere pressure (1 ATA = 101.325 kPa) after randomization until adimisson to the hospital. Participants will subsequently receive standard diagnosis and treatment service according to the guidelines during hospitalization. |
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| Control Group | No Intervention | Participants in the control group will not receive oxygen inhalation therapy during ambulance transportation. Participants will subsequently receive standard diagnosis and treatment service according to the guidelines during hospitalization. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBO | Drug | Oxygen inhalation through a mask at a rate of 10 L/min at 1 absolute atmosphere pressure (1 ATA = 101.325 kPa) |
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| Measure | Description | Time Frame |
|---|---|---|
| Time intervals of the prehospital transportation process | Time intervals between stroke onset, paramedic arrival on the scene, the departure from the scene, and admission to the hospital emergency department. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome | Incidence of adverse events during oxygen inhalation reported by the ambulance nurses. | Day 1 |
| Recruitment rate | The rate of patients successfully recruited to the trial by prehospital paramedics. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital,Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100053 | China |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| From the date of recruitment initiation until the date of recruitment completion, assessed up to 24 months. |
| Final diagnosis | The final diagnosis of the patients enrolled in the trial. | From the date of recruitment initiation until the date of recruitment completion, assessed up to 24 months. |
| Plateletto-lymphocyte ratio(PLR) | The platelet-to-lymphocyte ratio (PLR) is calculated as the absolute count of platelet divided by the absolute count of lymphocytes. | Day1 |
| Systemic immune-inflammation index (SII) | Systemic immune-inflammation index (SII) is calculated with the formula SII = (Peripheral platelet counts× Neutrophil counts)/Lymphocyte counts. | Day 1 |
| Neutrophil-to-lymphocyte ratio (NLR) | Neutrophil to lymphocyte ratio (NLR) is calculated as the absolute count of neutrophils divided by the absolute count of lymphocytes. | Day 1 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |