The Prehospital Administration of Normobaric Oxygen in Suspected Stroke (NO SUSPENSION)

Capital Medical University

Status and phase: Unknown; Phase 2

Conditions: Ischemic Stroke, Acute; Acute Stroke

Treatments: Drug: NBO

Study type: Interventional

Funder types: Other

Identifiers

NCT05351073

NO-SUSPENSION

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

Normobaric Oxygen Inhalation Group

Experimental group

Description:

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.

Treatment:

Drug: NBO

Control Group

No Intervention group

Description:

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.