Treatment Duration on Normobaric Hyperoxia in Acute Ischemic Stroke
NCT ID: NCT05404373
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2022-06-20
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Low flow oxygen group
patients were randomized into the Low flow oxygen group and immediately given 100% oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 1L/ min using a oxygen storage mask and keep giving oxygen for 4 hours.
Low flow oxygen
immediately given oxygen inhalation at a ventilation rate of 1L/ min using a oxygen storage mask and keep giving oxygen for 4 hours.
NBO group (2h)
patients were randomized into the NBO group (2h) and immediately given 100% oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 10L/ min using a oxygen storage mask and keep giving oxygen for 2 hours.
Normobaric Hyperoxia (NBO)
NBO was inhaled as early as possible before revascularization, and inhaled for 1h/2h/4h according to different groups
NBO group (4h)
patients were randomized into the NBO group (4h) and immediately given 100% oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 10L/ min using a oxygen storage mask and keep giving oxygen for 4 hours.
Normobaric Hyperoxia (NBO)
NBO was inhaled as early as possible before revascularization, and inhaled for 1h/2h/4h according to different groups
NBO group (6h)
patients were randomized into the NBO group (6h) and immediately given 100% oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 10L/ min using a oxygen storage mask and keep giving oxygen for 6 hours.
Normobaric Hyperoxia (NBO)
NBO was inhaled as early as possible before revascularization, and inhaled for 1h/2h/4h according to different groups
Interventions
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Normobaric Hyperoxia (NBO)
NBO was inhaled as early as possible before revascularization, and inhaled for 1h/2h/4h according to different groups
Low flow oxygen
immediately given oxygen inhalation at a ventilation rate of 1L/ min using a oxygen storage mask and keep giving oxygen for 4 hours.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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;
18 Years
ALL
No
Sponsors
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Tianjin Huanhu Hospital
OTHER
Capital Medical University
OTHER
Responsible Party
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Ji Xunming,MD,PhD
Principal Investigator
Locations
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Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China
Countries
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References
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Li W, Wang S, Liu L, Chen J, Lan J, Ding J, Chen Z, Yuan S, Qi Z, Wei M, Ji X. Normobaric Hyperoxia Combined With Endovascular Treatment Based on Temporal Gradient: A Dose-Escalation Study. Stroke. 2024 Jun;55(6):1468-1476. doi: 10.1161/STROKEAHA.123.046106. Epub 2024 May 15.
Other Identifiers
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TD-NBO
Identifier Type: -
Identifier Source: org_study_id