The Prehospital Administration of Normobaric Oxygen in Suspected Stroke

Capital Medical University100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Acute Stroke Ischemic Stroke, Acute

Interventions

NBODRUG

Oxygen inhalation through a mask at a rate of 10 L/min at 1 absolute atmosphere pressure (1 ATA = 101.325 kPa)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Xuanwu Hospital，Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Day 1

Secondary Outcomes

Safety Outcome

Incidence of adverse events during oxygen inhalation reported by the ambulance nurses.

Time frame: Day 1

Recruitment rate

The rate of patients successfully recruited to the trial by prehospital paramedics.

Time frame: 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.

Time frame: 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.

Time frame: Day1

Systemic immune-inflammation index (SII)

Systemic immune-inflammation index (SII) is calculated with the formula SII = (Peripheral platelet counts× Neutrophil counts)/Lymphocyte counts.

Time frame: 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.

Data from ClinicalTrials.gov

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