The Prehospital Administration of Normobaric Oxygen in Suspected Stroke

Acute Stroke Clinical Trial

— NO SUSPENSION  

Official title:

The Safety and Feasibility of Normobaric Oxygen Administration for SUSPEcted Acute Stroke uNder Pre-hoSpItal cONdition--A Pilot Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05351073
• Other study ID #: NO-SUSPENSION
• Status: Recruiting
• Phase: Phase 2
• Start date: January 21, 2022
• Est. completion date: October 20, 2022

Study information

• Verified date: April 2022
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 20, 2022
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Stroke
• Ischemic Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
China	Xuanwu Hospital,Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Secondary	Safety Outcome	Incidence of adverse events during oxygen inhalation reported by the ambulance nurses.	Day 1
Secondary	Recruitment rate	The rate of patients successfully recruited to the trial by prehospital paramedics.	From the date of recruitment initiation until the date of recruitment completion, assessed up to 24 months.
Secondary	Final diagnosis	The final diagnosis of the patients enrolled in the trial.	From the date of recruitment initiation until the date of recruitment completion, assessed up to 24 months.
Secondary	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.	Day1
Secondary	Systemic immune-inflammation index (SII)	Systemic immune-inflammation index (SII) is calculated with the formula SII = (Peripheral platelet counts× Neutrophil counts)/Lymphocyte counts.	Day 1
Secondary	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.	Day 1