Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China
NCT Number: NCT05404373
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 after cerebral ischemia occurs. The previous study by the investigators suggested that NBO therapy in the early stage of cerebral ischemia has a neuroprotective effect on ischemic brain injury. Although the neuroprotective effect of NBO has been demonstrated, the optimal duration of treatment for NBO to exert neuroprotective effect is still unclear. Therefore, further discussion of the duration of NBO treatment will contribute to the clinical application of NBO and provide a definite theoretical basis for the treatment of cerebral infarction.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Tianjin, Tianjin Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
NBO was inhaled as early as possible before revascularization, and inhaled for 1h/2h/4h according to different groups
immediately given oxygen inhalation at a ventilation rate of 1L/ min using a oxygen storage mask and keep giving oxygen for 4 hours.
Time frame: Within 72 hours after randomization
The infarct volume is evaluated by MRI or CT scan
Time frame: 24hours, 72hours, day7 after randomization
secondary clinical efficacy endpoint; the NIHSS is a stroke severity score composed of 11 items (range from 0 to 41, higher values indicate more severe deficits)
Time frame: 90 ± 10 days after randomization
the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death;with higher scores indicating more severe disability);The ratio of 0 to 2;
Time frame: Time Frame: 24 ± 6 hours
NIHSS score increased by more than 4 points);the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits);
Time frame: 30 ± 7 days, 90 ± 10 days after randomization;
secondary clinical efficacy endpoint; the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability,and 6=death)
Time frame: Time Frame: 4 hours ± 15 minutes
secondary imaging efficacy endpoint; Extended Treatment In Cerebral Ischemia (eTICI);The eTICI is an ordinal hierarchical scale ranging from 0 to 3, with higher scores indicating better antegrade reperfusion of the previously occluded target artery ischemic territory; eTICI 2B or 3 are defined as successful recanalization;
Time frame: 24 ± 6 hours, 72 ± 24 hours
Biomarkers for evaluation of BBB damage , brain injury and inflammation,etc:
Time frame: 24 ± 6 hours,
Including Headache, dizziness, nausea, vomiting, chest tightness, shortness of breath, cough,etc;
Time frame: 24 ± 6 hours;
NIHSS score increased by more than 4 points);the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits);clinical safety endpoint;
Time frame: 24± 12 hours hours after randomization
imaging safety endpoints;Deterioration in NIHSS score of ≥4 points within 24 hours;per ECASS III definition and per Heidelberg bleeding classification
Time frame: 24± 12 hours hours after randomization
imaging safety endpoints;per ECASS III definition and per Heidelberg bleeding classification
Time frame: 90 ± 10 days after randomization
clinical safety endpoint; Ratio of total deaths from all causes to all enrollments
Time frame: 90 ± 10 days after randomization
clinical safety endpoint;
Time frame: 24± 12 hours hours after randomization
clinical safety endpoint;
Time frame: 90 ± 10 days after randomization;
clinical safety endpoint; Stroke-related deaths as a proportion of all participants
Time frame: 0 hours, 2 hours, 4 hours after randomization;
clinical safety endpoint;
Time frame: 0 hours, 2 hours, 4 hours after randomization;
clinical safety endpoint;
Time frame: 0 hours, 2 hours, 4 hours after randomization;
clinical safety endpoint;
Time frame: 0 hours, 2 hours, 4 hours after randomization;
clinical safety endpoint;
Capital Medical University
Other
The Efficacy and Safety of Normobaric Hyperoxia on Treatment Duration for Acute Ischemic Stroke Patients With Endovascular Treatment
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