Adjuvant Cerebroprotection Using Normobaric Hyperoxia in Pre-hospital Patients with Suspected Stroke

Launched by CAPITAL MEDICAL UNIVERSITY · Jan 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called normobaric hyperoxia therapy, which involves inhaling extra oxygen, to see if it can help protect the brain in patients who may be having a stroke. The focus is on people who show signs of a specific type of stroke caused by a blockage in the blood vessels in the brain and who arrive at the hospital within 6 hours of their symptoms starting. The researchers aim to find out if this treatment is safe and effective when given before patients reach the hospital.

To be eligible for the trial, participants should be between 18 and 80 years old and have symptoms that strongly suggest a new stroke, with no prior strokes or significant disabilities affecting them. They also need to be able to give consent or have a representative do so for them. If someone joins the trial, they will receive the oxygen therapy and will be monitored closely to see how well it works and any side effects that may occur. It's important to note that certain health conditions or other treatments may prevent someone from participating in this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 to 80 years old;
• • Signs and symptoms are consistent with a new acute stroke, with low possibility of stroke mimics (e.g., no sudden coma, prior seizure disorder, suspected hypoglycemia);
• • No prior stroke;
• • The time from stroke onset/last seen well to randomization is within 6 hours;
• • Paramedic-obtained FAST-ED score \>= 3 (The enrollment of patients with a FAST-ED score of 3 is prespecified to constitute no more than 10% of the total study population);
• • No significant pre-stroke disability (pre-stroke mRS 0-1);
• • Signed informed consent from the patient or the legally authorized representative (LAR).
• Exclusion Criteria:
• • Endotracheal intubation in the field (prior to consent);
• • Respiratory rate \<= 10 or \>= 30 breaths per minute;
• • Oxygen-dependence at baseline to maintain SaO2 \> 95%;
• • Known history of severe chronic obstructive pulmonary disease (FEV1 less than 1.0), New York Heart Association (NYHA) Heart Failure Class III, acute pulmonary infection or aspiration pneumonia, prior to enrollment;
• • Seizure at stroke onset;
• • Exhibiting symptoms of vomiting, severe headache, or unconscious;
• • Known pregnancy: women of childbearing age (18 to 44 years old according to the CDC's Division of Reproductive Health) will be asked about their pregnancy status.
• • Participating in another clinical trial, or completed participation within prior 30 days;
• • Receiving other neuroprotective agent (e.g., edaravone dexborneol, n-butylphthalide);
• • Life expectancy \< 90 days due to comorbidities;
• • Unlikely to complete the 90-day follow-up visit.