The Prehospital Administration of Normobaric Oxygen in Suspected Stroke

NCT ID: NCT05351073

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-21
• Study Completion Date: 2022-10-20

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.

Conditions

Acute Stroke; Ischemic Stroke, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Normobaric Oxygen Inhalation Group

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.

Group Type: EXPERIMENTAL

NBO

Intervention Type: DRUG

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

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

NBO

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming,MD,PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xuanwu Hospital，Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Xunming Ji, MD

Role: primary

jixm@ccmu.edu.cn

010-83198952

Milan Jia, MM

Role: backup

jiaml@ccmu.edu.cn

8618323209109

Other Identifiers

NO-SUSPENSION

Identifier Type: -

Identifier Source: org_study_id