Oxygen Concentration Target in Stroke Endovascular Treatment
NCT ID: NCT06224426
Last Updated: 2024-12-02
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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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-02-01
2026-12-31
Brief Summary
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* 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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Normobaric high-concentration oxygen (NBHO) group
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 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.
Normobaric low-concentration oxygen (NBLO) group
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.
Normobaric 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.
Interventions
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Normobaric 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.
Normobaric 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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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Ruquan Han
Lead Investigator
Principal Investigators
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Ruquan Han, Ph.D
Role: STUDY_DIRECTOR
Department of Anesthesiology, Beijing TianTan Hospital, Capital Medical University
Locations
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Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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zkd20231121
Identifier Type: -
Identifier Source: org_study_id