Clinical trial NCT06224426: Oxygen Concentration Target in Stroke Endovascular Treatment
Official title: Oxygenation Targets for Endovascular Therapy in Acute Ischemic Stroke Patients (Oxy-TARGET)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Keywords: Endovascular therapy
Acute ischemic stroke
Normobaric hyperoxia
Early neurological improvement
General anesthesia
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the incidence of early neurological improvement (ENI)
timeFrame: 24±2 hours after EVT
Secondary outcomes:
measure: ΔNIHSS at 24±2 hours after EVT
timeFrame: 24±2 hours after EVT
measure: the final infarct volume
timeFrame: 72 hours post-randomization
measure: early neurological deterioration (END)
timeFrame: 1 day after reperfusion therapy
measure: Postoperative pulmonary complications
timeFrame: within 7 days after endovascular therapy
measure: overall mRS distribution at 90 days
timeFrame: 90 days after stroke onset
measure: favorable functional outcome
timeFrame: 90 days after stroke onset
Other outcomes:
measure: Postoperative baseline PaO2
timeFrame: From the end of the intervention procedure until the time just before the tracheal tube is removed.
measure: Postoperative baseline oxygenation index
timeFrame: From the end of the intervention procedure until the time just before the tracheal tube is removed.
measure: symptomatic ICH
timeFrame: 24±12 hours after EVT
measure: all-cause mortality at 90 days
timeFrame: 90 days after stroke onset
measure: stroke-related death
timeFrame: within 7 days after endovascular therapy
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Department of Anesthesiology, Beijing TianTan Hospital, Capital Medical University
name: Ruquan Han, Ph.D
role: STUDY_DIRECTOR
References: