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Not yet taking people in ChinaPhase 3

Tests inhaled oxygen to protect the brain in suspected stroke

Tests inhaled high-oxygen therapy started before hospital in adults with suspected acute stroke.

Key facts

Who runs it
Capital Medical University
Where
Beijing, ChinaSee the site
Trial code
Registry title
Adjuvant Cerebroprotection Using Normobaric Hyperoxia in Pre-hospital Patients with Suspected Stroke
Status
Not yet recruiting
Phase
Phase 3
People taking part
1,000 people, planned
Started
1 Feb 2025
Expected to end
30 Jan 2028
Type of study
Interventional, 2 groups
Treatments tested
  • NBO
  • Control
Record updated
30 January 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 80 with signs of a new stroke who can start oxygen treatment within 6 hours of symptom onset, beginning before reaching the hospital.

Age
18 to 80 years old.
Sex
All sexes can join.
Disease stage
New acute stroke with a low chance of looking like another condition, within 6 hours of onset or last seen well. FAST-ED score of 3 or more, measured by the paramedic.
Earlier treatment
Must not be receiving another neuroprotective drug (for example edaravone dexborneol or n-butylphthalide). Must not be in another clinical trial now or have finished one in the past 30 days.

Main reasons for not taking part

  • Any earlier stroke or significant disability before the stroke (pre-stroke mRS above 1)
  • Needing extra oxygen at baseline, or severe lung or heart disease (severe COPD, NYHA Class III heart failure)
  • Seizure at stroke onset, vomiting, severe headache or being unconscious
  • Known pregnancy
  • Life expectancy under 90 days or unlikely to complete the 90-day follow-up visit

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Endotracheal intubation in the field (prior to consent)
  • 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
  • Participating in another clinical trial, or completed participation within prior 30 days
  • Receiving other neuroprotective agent (e.g., edaravone dexborneol, n-butylphthalide)
  • Seizure at stroke onset
  • 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
  • Respiratory rate <= 10 or >= 30 breaths per minute
  • Oxygen-dependence at baseline to maintain SaO2 > 95%
  • Exhibiting symptoms of vomiting, severe headache, or unconscious
  • Life expectancy < 90 days due to comorbidities
  • Unlikely to complete the 90-day follow-up visit

Where in China

  • Xuanwu Hospital, Capital Medical UniversityBeijing, ChinaContact: Wenbo Hu, MDNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • NBOTreatment being tested

    NBO will be conducted with inhalation of 100% oxygen. NBO will be used in conjunction with best medical practice.

  • ControlOther group

    Best medical treatment

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Adjuvant Cerebroprotection Using Normobaric Hyperoxia in Pre-hospital Patients with Suspected Stroke
Plain-language title
Tests inhaled oxygen to protect the brain in suspected strokeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
30 January 2025