Ischemic Stroke
Conditions
Keywords
Endovascular therapy, Acute ischemic stroke, Normobaric hyperoxia, Early neurological improvement, General anesthesia
Brief summary
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.
Detailed description
The optimal fraction of inspired oxygen (FiO2) during EVT under general anesthesia is currently uncertain. This is a randomized controlled trial (RCT) designed to assess the impact of normobaric high-concentration oxygen versus low-concentration oxygen on early neurological function following EVT. It is a prospective, open-label, parallel-design RCT planned to be conducted at Beijing Tiantan Hospital, Capital Medical University. It is anticipated that 200 cases of AIS patients undergoing EVT under general anesthesia will be consecutively enrolled from 2024 to 2026. Eligible participants will be randomly assigned in a 1:1 ratio. After general anesthesia induction, patients will receive continuous inhalation of oxygen with either FiO2=80% or FiO2=30% through endotracheal intubation until the end of the procedure, with a gas flow rate set at 4 L/min. The positive end-expiratory pressure (PEEP) is uniformly set to 5 cmH2O to balance its effect on pulmonary oxygen delivery. The primary outcome will be the occurrence of early neurological improvement (NIHSS score of 10 points 24±2 hours after EVT). Safety outcomes include potential adverse events such as site infection, three-month mortality, etc.
Interventions
OTHERNormobaric high-concentration oxygen
During endovascular therapy, eligible participants will receive FiO2=80% through endotracheal intubation, with a gas flow rate set at 4 L/min.
OTHERNormobaric low-concentration oxygen
During endovascular therapy, eligible participants will receive FiO2=30% through endotracheal intubation, with a gas flow rate set at 4 L/min.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years. 2. Anterior circulation occlusive stroke is confirmed by CT angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography (DSA), and occlusions of intracranial internal carotid artery (ICA) or M1 segment of the middle cerebral artery (MCA) were involved. 3. NIHSS score at admission: 6-20. 4. Randomization can be completed within 24 hours after stroke onset.
Exclusion criteria
1. Stroke onset within 6-24 hours with a CT perfusion imaging (CTP)-assessed mismatched area\<15 ml. 2. Presence of anemia, defined as hemoglobin levels o below 120 g/L in men and below 110 g/L in women. 3. Pre-stroke modified Rankin scale (mRS) score ≥2. 4. Complicated by severe agitation and seizures. 5. Evidence of intracranial hemorrhage at admission. 6. Presence of chronic obstructive pulmonary disease, asthma, or other respiratory conditions, or requirement for daily supplemental oxygen or mechanical ventilation. 7. Baseline arterial blood gas analysis indicating impaired gas exchange: PaO2 \< 60 mmHg on room air, or oxygenation index (PaO2/FiO2) \< 300 mmHg with supplemental oxygen. 8. Emergency chest CT reveals significant pulmonary parenchymal infection. 9. An oxygen mask or ventilator must be used before anesthesia to maintain a SpO2≥94%. 10. Loss of airway protective reflex or vomiting aspiration upon admission.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the incidence of early neurological improvement (ENI) | 24±2 hours after EVT | ENI is defined as an NIHSS score of \<10 points at 24±2 hours after EVT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the final infarct volume | 72 hours post-randomization | After collecting cranial CT images, the infarct volume was delineated using ITK-SNAP software. |
| ΔNIHSS at 24±2 hours after EVT | 24±2 hours after EVT | baseline NIHSS score - NIHSS score at 24±2 h |
| early neurological deterioration (END) | 1 day after reperfusion therapy | an increase of ≥4 from the baseline NIHSS score on day 1 after reperfusion therapy in AIS patients |
| Postoperative pulmonary complications | within 7 days after endovascular therapy | defined as a composite measure encompassing pulmonary infections, atelectasis, pleural effusion, respiratory failure, bronchospasm, and pneumothorax |
| overall mRS distribution at 90 days | 90 days after stroke onset | modified Rankin scale (mRS) scores are distributed between 0 and 6 |
| favorable functional outcome | 90 days after stroke onset | an mRS score of 0-2 at 90 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| symptomatic ICH | 24±12 hours after EVT | defined as the presence of hemorrhage on CT at 24±12 h accompanied by an NIHSS score increase≥4 |
| all-cause mortality at 90 days | 90 days after stroke onset | deaths from any cause during the 3-month follow-up period |
| stroke-related death | within 7 days after endovascular therapy | typically defined as death directly attributable to the stroke and its complications, encompassing but not limited to severe cerebral edema, brain herniation, infections, cardiac diseases, pulmonary embolism, and deep vein thrombosis occurring during the acute phase of AIS |
| Postoperative baseline oxygenation index | From the end of the intervention procedure until the time just before the tracheal tube is removed. | oxygenation index=PaCO2/FiO2 |
| Postoperative baseline PaO2 | From the end of the intervention procedure until the time just before the tracheal tube is removed. | Arterial partial oxygen pressure based on arterial blood gas |
Countries
China
Contacts
Primary ContactRuquan Han, Ph.D
Backup ContactZhengfang Hu, M.D
Outcome results
None listed