The Prehospital Administration of Normobaric Oxygen in Suspected Stroke

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Safety and Feasibility of Normobaric Oxygen Administration for SUSPEcted Acute Stroke uNder Pre-hoSpItal cONdition--A Pilot Trial

Conditions
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Acute Stroke, Ischemic Stroke, Acute

Intervention / Treatment
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* Drug: NBO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or more. Suspected stroke screened by the Gaze- Face Arm Speech Time scale (G-FAST score ≥ 1). Within 24 hours of symptom onset SpO2 > 94%. Exclusion Criteria: Coma: Glasgow coma score (GCS) < 8. Hypoglycemia: Blood glucose < 2.8mmol /L. Known history of seizure. Recent stroke or brain trauma within past 30 days. Previous Modified Rankin Scale (mRS) ≥2. Rapid improvement of neurological dysfunction (deficit present less than 15 min). Unstable vital signs. Known respiratory distress, respiratory dysfunction, or any contraindications to high-flow oxygen inhalation therapy. Patient unable to cooperate with the trial procedure. Any condition which might increase the risk to the patient in the judgment of the investigator. Patient or available legally authorized representative unable to provide written or witnessed oral consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normobaric Oxygen Inhalation Group<br>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. | Drug: NBO<br>* Oxygen inhalation through a mask at a rate of 10 L/min at 1 absolute atmosphere pressure (1 ATA = 101.325 kPa)<br>|
| No Intervention: Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute stroke, Normobaric oxygen, Stroke neuroprotection