Actively Recruiting
Oxygen Concentration Target in Stroke Endovascular Treatment
Led by Beijing Tiantan Hospital · Updated on 2024-12-02
200
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to compare the effects of different concentrations of normobaric oxygen on early neurological improvement in acute ischemic stroke (AIS) patients receiving endovascular therapy (EVT). The main questions it aims to answer are: * Evaluating the impact of normobaric high-concentration oxygen versus low-concentration oxygen on early neurological function after EVT. * Evaluating the safety of high and low normobaric oxygen concentration in patients with ischemic stroke. Participants will (1) receive EVT under general anesthesia; (2) be randomly assigned 1:1 to receive oxygen therapy with FiO2=80% or FiO2=30% through endotracheal intubation during the operation, and the gas flow rate was set at 4L /min.
CONDITIONS
Official Title
Oxygen Concentration Target in Stroke Endovascular Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed anterior circulation occlusive stroke involving the intracranial internal carotid artery or M1 segment of the middle cerebral artery by CTA, MRA, or DSA
- NIH Stroke Scale score at admission between 6 and 20
- Ability to complete randomization within 24 hours after stroke onset
You will not qualify if you...
- Stroke onset 6 to 24 hours prior with CT perfusion imaging showing mismatched area less than 15 ml
- Anemia with hemoglobin below 120 g/L for men or below 110 g/L for women
- Pre-stroke modified Rankin scale score of 2 or higher
- Severe agitation or seizures
- Evidence of intracranial hemorrhage at admission
- Chronic obstructive pulmonary disease, asthma, or other respiratory conditions requiring daily supplemental oxygen or mechanical ventilation
- Baseline arterial blood gas showing impaired gas exchange (PaO2 less than 60 mmHg on room air or oxygenation index below 300 mmHg with supplemental oxygen)
- Emergency chest CT showing significant lung infection
- Need for oxygen mask or ventilator before anesthesia to keep SpO2 at or above 94%
- Loss of airway protective reflex or vomiting aspiration upon admission
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
Research Team
R
Ruquan Han, Ph.D
CONTACT
Z
Zhengfang Hu, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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