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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normobaric high-concentration oxygen (NBHO) group | Experimental | After preoxygenating (FiO2=100%, 6 L/min) with a face mask for 3 min, patients will be sequentially administered intravenous sufentanil 0.2 µg/kg followed by propofol 2 mg/kg. Once the eyelash reflex was absent, all patients received 0.6 mg/kg rocuronium, with an endotracheal tube inserted approximately 90 seconds later. Mechanical ventilation is set to volume-controlled ventilation (VCV) mode, fresh gas flow 4 L/min, tidal volume (Vt) 6-8 ml/kg, respiratory rate (RR) 12-14 breaths/min, and positive end-expiratory pressure (PEEP) 5 cmH2O. End-tidal carbon dioxide (PetCO2) will be continuously monitored, maintaining it between 35-40 mmHg. Based on group allocation, the NBHO group will adjust the FiO2 at 80% throughout the surgery. Anesthesia will be maintained through total intravenous anesthesia, continuously infusing remifentanil 0.05-0.1 µg/kg/min and propofol 4-6 mg/kg/min, with intermittent 10 mg rocuronium as needed. |
|
| Normobaric low-concentration oxygen (NBLO) group | Experimental | After preoxygenating (FiO2=100%, 6 L/min) with a face mask for 3 min, patients will be sequentially administered intravenous sufentanil 0.2 µg/kg followed by propofol 2 mg/kg. Once the eyelash reflex was absent, all patients received 0.6 mg/kg rocuronium, with an endotracheal tube inserted approximately 90 seconds later. Mechanical ventilation is set to volume-controlled ventilation (VCV) mode, fresh gas flow 4 L/min, tidal volume (Vt) 6-8 ml/kg, respiratory rate (RR) 12-14 breaths/min, and positive end-expiratory pressure (PEEP) 5 cmH2O. End-tidal carbon dioxide (PetCO2) will be continuously monitored, maintaining it between 35-40 mmHg. Based on group allocation, the NBLO group will adjust the FiO2 at 30% throughout the surgery. Anesthesia will be maintained through total intravenous anesthesia, continuously infusing remifentanil 0.05-0.1 µg/kg/min and propofol 4-6 mg/kg/min, with intermittent 10 mg rocuronium as needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normobaric high-concentration oxygen | Other | During endovascular therapy, eligible participants will receive FiO2=80% through endotracheal intubation, with a gas flow rate set at 4 L/min. |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of early neurological improvement (ENI) | ENI is defined as an NIHSS score of <10 points at 24±2 hours after EVT | 24±2 hours after EVT |
| Measure | Description | Time Frame |
|---|---|---|
| ΔNIHSS at 24±2 hours after EVT | baseline NIHSS score - NIHSS score at 24±2 h | 24±2 hours after EVT |
| the final infarct volume | After collecting cranial CT images, the infarct volume was delineated using ITK-SNAP software. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative baseline PaO2 | Arterial partial oxygen pressure based on arterial blood gas | From the end of the intervention procedure until the time just before the tracheal tube is removed. |
| Postoperative baseline oxygenation index |
Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruquan Han, Ph.D | Contact | +86 13701285393 | ruquan.han@ccmu.edu.cn | |
| Zhengfang Hu, M.D | Contact | +86 13041084927 | huzhengfang78@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ruquan Han, Ph.D | Department of Anesthesiology, Beijing TianTan Hospital, Capital Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100070 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39755573 | Derived | Hu Z, Zhang K, Wu Y, Wang X, Zhang Z, Hou X, Jian M, Wang Y, Liu H, Wang A, Han R, Liang F. Oxygenation targets for endovascular therapy in acute ischemic stroke patients (Oxy-TARGET): protocol for a single-centre, open-label randomised controlled trial. BMJ Open. 2025 Jan 4;15(1):e086234. doi: 10.1136/bmjopen-2024-086234. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Normobaric low-concentration oxygen | Other | During endovascular therapy, eligible participants will receive FiO2=30% through endotracheal intubation, with a gas flow rate set at 4 L/min. |
|
| 72 hours post-randomization |
| early neurological deterioration (END) | an increase of ≥4 from the baseline NIHSS score on day 1 after reperfusion therapy in AIS patients | 1 day after reperfusion therapy |
| Postoperative pulmonary complications | defined as a composite measure encompassing pulmonary infections, atelectasis, pleural effusion, respiratory failure, bronchospasm, and pneumothorax | within 7 days after endovascular therapy |
| overall mRS distribution at 90 days | modified Rankin scale (mRS) scores are distributed between 0 and 6 | 90 days after stroke onset |
| favorable functional outcome | an mRS score of 0-2 at 90 days | 90 days after stroke onset |
oxygenation index=PaCO2/FiO2
| From the end of the intervention procedure until the time just before the tracheal tube is removed. |
| symptomatic ICH | defined as the presence of hemorrhage on CT at 24±12 h accompanied by an NIHSS score increase≥4 | 24±12 hours after EVT |
| all-cause mortality at 90 days | deaths from any cause during the 3-month follow-up period | 90 days after stroke onset |
| stroke-related death | 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 | within 7 days after endovascular therapy |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |