Status:
COMPLETED
Treatment Duration on Normobaric Hyperoxia in Acute Ischemic Stroke
Lead Sponsor:
Capital Medical University
Collaborating Sponsors:
Tianjin Huanhu Hospital
Conditions:
Stroke, Acute
Neuroprotection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Normoxia Hyperoxia (NBO) is a neuroprotective approach that can be implemented early. NBO is simple and non-invasive and can be used at home or in an ambulance to ensure the shortest possible time aft...
Eligibility Criteria
Inclusion
- Symptoms and signs were consistent with acute anterior circulation stroke,
- NIHSS score≥6分;Alberta Stroke Program Early CT score (ASPECTS)≥6;
- Met the indications for endovascular therapy;
- (Level of consciousness)NIHSS score 0 or 1; MRS score was 0-1 before stroke
- The time from onset to randomization was within 24 hours;
- Preoperative CTA or MRA confirmed the presence of large vessel occlusion (internal carotid artery or middle cerebral artery M1, M2 segments);
- Patients and their families signed informed consent
Exclusion
- Rapid neurological function improvement, NIHSS score less than 10 points, or evidence of vessel recanalization prior to randomization;
- Seizures at stroke onset;
- Intracranial hemorrhage;
- Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal;
- Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with INR \> 3.0 or PTT \> 3 times normal;
- Platelet count of less than 100,000 per cubic millimeter;
- Severe hepatic or renal dysfunction;
- Severe, sustained hypertension (Systolic Blood Pressure \>185 mmHg or Diastolic Blood Pressure \>110 mmHg)
- Baseline blood glucose of \<50mg/dL (2.78 mmol) or \>400mg/dL (22.20 mmol) Active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;
- \>3 L/min oxygen required to maintain peripheral arterial oxygen saturation (SaO2) 95% as per current stroke management guidelines;
- Medically unstable;
- Life expectancy\<90 days;
- Patients who could not complete the 90-day follow-up;
- Evidence of intracranial tumor;
- Patients with anemia or polycythemia vera or other situations that require urgent oxygen inhalation;
- Patients with upper gastrointestinal bleeding or nausea or vomiting so that they cannot cooperate with the mask to inhale oxygen.
- A history of severe allergies to contrast agents;
Key Trial Info
Start Date :
June 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05404373
Start Date
June 20 2022
End Date
September 30 2023
Last Update
December 6 2023
Active Locations (1)
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1
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China