Status:
UNKNOWN
The Prehospital Administration of Normobaric Oxygen in Suspected Stroke
Lead Sponsor:
Capital Medical University
Conditions:
Acute Stroke
Ischemic Stroke, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 tr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 20 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05351073
Start Date
January 21 2022
End Date
October 20 2022
Last Update
April 28 2022
Active Locations (1)
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1
Xuanwu Hospital，Capital Medical University
Beijing, Beijing Municipality, China, 100053