Adjuvant Cerebroprotection Using Normobaric Hyperoxia in Pre-hospital Patients with Suspected Stroke (NCT06801457) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Adjuvant Cerebroprotection Using Normobaric Hyperoxia in Pre-hospital Patients with Suspected Stroke
China1,000 participantsStarted 2025-02-01
Plain-language summary
The primary objective of this study is to determine the efficacy and safety of inhaled normobaric hyperoxia therapy (NBO) beginning in the pre-hospital setting in patients with suspected acute cerebral ischemia (ACI) due to large vessel occlusion presenting within 6 hours of symptom onset.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Level of disability at 90 days measured by modified Rankin scale (mRS) score