The Prehospital Administration of Normobaric Oxygen in Suspected Stroke

Phase 2

• Conditions: Acute Stroke; Ischemic Stroke, Acute
• Interventions: Drug: NBO

• Registration Number: NCT05351073
• Lead Sponsor: Capital Medical University

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.

Study Timeline

• Study Start: 2022-01-21
• Study First Submitted: 2022-02-22
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-24
• Last Update Submitted: 2022-04-24
• Study First Posted: 2022-04-28
• Last Update Posted: 2022-04-28
• Primary Completion: 2022-07-20
• Study Completion: 2022-10-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normobaric Oxygen Inhalation Group	NBO	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Safety Outcome	Day 1	Incidence of adverse events during oxygen inhalation reported by the ambulance nurses.
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.
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.
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.
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.

Trial Locations

Locations (1)

Xuanwu Hospital，Capital Medical University; 🇨🇳 Beijing, Beijing, China